Abviva, Inc. was established to develop and commercialize diagnostic and therapeutic products from a novel breast cancer growth inhibitory protein. Research scientists at the prestigious University of Michigan Cancer Center discovered a secreted protein produced in normal breast epithelial cells that inhibits the growth of breast cancer.
The document discusses the use of genomics in early stage breast cancer treatment. It describes how genomics can provide personalized treatment by understanding each tumor's biology and risk of recurrence. Two multi-gene assays, Mammaprint and Oncotype DX, are discussed. Oncotype DX has been clinically validated to predict recurrence risk and chemotherapy benefit in node-negative patients. Studies also show it can predict outcomes for node-positive patients treated with tamoxifen. The results from these assays often change treatment decisions by identifying patients unlikely to benefit from chemotherapy.
Speaker: Lisette Stork-Sloots, Sr Program Director at Agendia, discusses how their technology, MammaPrint was commercialized.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
The document discusses several gene expression profiling tests for early breast cancer, including OncotypeDX, MammaPrint, and TAILORx. OncotypeDX analyzes the expression of 21 genes to calculate a recurrence score that predicts the likelihood of distant recurrence within 10 years for tamoxifen-treated patients. MammaPrint analyzes 70 genes to classify patients into low or high risk groups. The TAILORx clinical trial aims to determine which patients with early breast cancer and OncotypeDX scores of 11-25 benefit from chemotherapy using a randomized design.
There are several genomic tests that can help predict the risk of recurrence of early-stage breast cancer and determine the benefits of chemotherapy, including Oncotype DX, MammaPrint, Mammostrat, and Prosigna. Oncotype DX analyzes the activity of 21 genes and assigns a Recurrence Score between 0-100, with scores below 18 indicating a low risk cancer unlikely to benefit from chemotherapy. MammaPrint analyzes 70 genes to determine a low or high risk classification. Mammostrat measures levels of 5 genes to calculate a risk index score. Prosigna analyzes 58 genes to estimate the risk of distant recurrence within 10 years as low, intermediate, or high risk. Of the tests, Oncotype
The document provides an overview of genomics in breast cancer and summarizes the Oncotype DX genomic assay. It discusses how the assay analyzes the expression levels of 21 genes in breast tumor tissue to provide a Recurrence Score that quantifies a patient's risk of recurrence and predicts who will benefit from chemotherapy. Clinical studies have shown the assay stratifies patients into low, intermediate, and high risk groups and identifies those unlikely to benefit from chemotherapy while high risk patients see significant reduction in recurrence with chemotherapy. The assay is recommended in clinical guidelines and widely covered by insurance.
OVA1 is a blood test that can help physicians evaluate whether an ovarian mass is likely to be cancerous or benign prior to planned surgery. It measures biomarkers in blood to provide a numerical risk score. A score at or above certain thresholds indicates higher risk of malignancy and potential need for referral to an oncologist. The test has been shown in clinical trials to identify 96% of cancers with 95% accuracy in ruling out malignancy.
This document discusses Oncotype DX, a 21-gene diagnostic test for breast cancer recurrence developed by Genomic Health. It measures gene expression from tumor samples using RT-qPCR to determine a Recurrence Score predicting recurrence risk and chemotherapy benefit. Oncotype DX was validated using large clinical trials and provides a quantitative recurrence risk assessment to guide treatment decisions. Though regulated under CLIA, Oncotype DX avoids the lengthy FDA approval process required for diagnostic tests. Genomic Health continues developing additional cancer diagnostic tests.
The document discusses the use of genomics in early stage breast cancer treatment. It describes how genomics can provide personalized treatment by understanding each tumor's biology and risk of recurrence. Two multi-gene assays, Mammaprint and Oncotype DX, are discussed. Oncotype DX has been clinically validated to predict recurrence risk and chemotherapy benefit in node-negative patients. Studies also show it can predict outcomes for node-positive patients treated with tamoxifen. The results from these assays often change treatment decisions by identifying patients unlikely to benefit from chemotherapy.
Speaker: Lisette Stork-Sloots, Sr Program Director at Agendia, discusses how their technology, MammaPrint was commercialized.
Part of Dx2010, a workshop at MaRS focused on best practices and regulatory considerations for developing gene-based diagnostic and prognostic tests.
The document discusses several gene expression profiling tests for early breast cancer, including OncotypeDX, MammaPrint, and TAILORx. OncotypeDX analyzes the expression of 21 genes to calculate a recurrence score that predicts the likelihood of distant recurrence within 10 years for tamoxifen-treated patients. MammaPrint analyzes 70 genes to classify patients into low or high risk groups. The TAILORx clinical trial aims to determine which patients with early breast cancer and OncotypeDX scores of 11-25 benefit from chemotherapy using a randomized design.
There are several genomic tests that can help predict the risk of recurrence of early-stage breast cancer and determine the benefits of chemotherapy, including Oncotype DX, MammaPrint, Mammostrat, and Prosigna. Oncotype DX analyzes the activity of 21 genes and assigns a Recurrence Score between 0-100, with scores below 18 indicating a low risk cancer unlikely to benefit from chemotherapy. MammaPrint analyzes 70 genes to determine a low or high risk classification. Mammostrat measures levels of 5 genes to calculate a risk index score. Prosigna analyzes 58 genes to estimate the risk of distant recurrence within 10 years as low, intermediate, or high risk. Of the tests, Oncotype
The document provides an overview of genomics in breast cancer and summarizes the Oncotype DX genomic assay. It discusses how the assay analyzes the expression levels of 21 genes in breast tumor tissue to provide a Recurrence Score that quantifies a patient's risk of recurrence and predicts who will benefit from chemotherapy. Clinical studies have shown the assay stratifies patients into low, intermediate, and high risk groups and identifies those unlikely to benefit from chemotherapy while high risk patients see significant reduction in recurrence with chemotherapy. The assay is recommended in clinical guidelines and widely covered by insurance.
OVA1 is a blood test that can help physicians evaluate whether an ovarian mass is likely to be cancerous or benign prior to planned surgery. It measures biomarkers in blood to provide a numerical risk score. A score at or above certain thresholds indicates higher risk of malignancy and potential need for referral to an oncologist. The test has been shown in clinical trials to identify 96% of cancers with 95% accuracy in ruling out malignancy.
This document discusses Oncotype DX, a 21-gene diagnostic test for breast cancer recurrence developed by Genomic Health. It measures gene expression from tumor samples using RT-qPCR to determine a Recurrence Score predicting recurrence risk and chemotherapy benefit. Oncotype DX was validated using large clinical trials and provides a quantitative recurrence risk assessment to guide treatment decisions. Though regulated under CLIA, Oncotype DX avoids the lengthy FDA approval process required for diagnostic tests. Genomic Health continues developing additional cancer diagnostic tests.
This study evaluated the association between preoperative serum CA-125 levels and clinical pathological characteristics in 87 women with endometriosis. The study found significant correlations between higher CA-125 levels and more advanced endometriosis stage, larger lesion size, and higher adhesion scores. However, there were no significant associations between CA-125 levels and age, marital status, patient complaints, or pelvic pain scores. The study suggested CA-125 cut-off levels of 37 U/ml for premenopausal patients and 35 U/ml for postmenopausal patients to help determine if surgery is needed.
Oncotype DX is a 21-gene diagnostic test developed by Genomic Health to analyze gene expression in breast cancer tumors. It provides a Recurrence Score that quantitatively estimates the likelihood of cancer recurrence and predicts whether chemotherapy will provide benefit. The test analyzes the expression of 16 cancer-related genes and 5 reference genes using RT-qPCR. Validation studies have shown the Recurrence Score strongly correlates with actual cancer recurrence. While approved through CLIA, Genomic Health is also pursuing FDA approval and expanding the test to other cancers.
- Three major molecular assays have been developed for prognostic assessment of breast cancer: Oncotype DX, Mammaprint, and Prosigna.
- Oncotype DX uses a 21-gene signature to predict recurrence risk in ER+ breast cancer. Mammaprint uses a 70-gene signature and Prosigna uses the PAM50 intrinsic subtyping algorithm.
- Clinical trials have validated the use of these assays in lymph node positive and negative disease to predict chemotherapy benefit and guide treatment decisions. Ongoing research aims to further refine risk assessment and subclassify breast cancer.
ROMA is a risk stratification tool that uses a patient's levels of HE4, CA125, and menopausal status to provide a numerical score indicating their risk of having ovarian cancer. The score is derived through an established formula and classifies a patient as either high or low risk. Studies show ROMA correctly identifies 94% of ovarian cancers and has superior performance over single biomarker tests in assessing cancer risk. However, it is not intended as a standalone diagnostic and still requires clinical evaluation.
Breast cancer is the most common cancer among American women (American Cancer Society), but only 5-10 percent of breast cancer cases are hereditary. Of those cases, roughly 20-25 percent are linked to mutations in the BRCA1 and BRCA2 genes (BRCA stands for BReast CAncer susceptibility). View the infographic above for more on the genetics of breast cancer.
For more information on breast cancer, visit the website for Dana-Farber’s Susan F. Smith Center for Women’s Cancers Breast Oncology Program: http://www.dana-farber.org/Adult-Care/Treatment-and-Support/Breast-Cancer.aspx
This document provides a guide to understanding BRCA1 and BRCA2 genes and managing cancer risks for carriers. It discusses background on the genes and associated cancer risks, screening and risk reduction options for breast and ovarian cancer, sharing genetic information with family, and other topics like insurance and family planning considerations. The key points are that BRCA1/2 carriers have high lifetime risks of breast and ovarian cancer, and screening and risk-reducing surgeries are options to help manage those risks, though neither prevent cancer. Genetic testing of relatives is also recommended to identify others who may benefit from similar risk management strategies.
A review of breast cancer in Saudi Arabia with an update on all aspects of breast cancer management including Diagnosis, Family History, Surgery (& Reconstructive Surgery), Sentinel Node Biopsy and Adjuvant Chemo, Radio and Hormone Therapy.
This document provides updates to guidelines for several types of cancer screening, including breast, colorectal, cervical, prostate, lung, and ovarian cancer. For each cancer, it discusses what screening tests are recommended, for which populations and age groups, and how frequently screening should occur. It also notes some controversial issues and new recommendations from groups like the US Preventive Services Task Force.
Via Christi 50+ Lunch and Learn: Can I prevent breast cancer?Via Christi Health
This document discusses breast cancer risks, prevention, and screening. It outlines risk factors such as age, family history, breast density, and lifestyle factors. Some risks cannot be reduced, but maintaining a healthy weight, exercise, limiting alcohol, and avoiding long-term hormone replacement therapy can potentially lower risk. Screening through mammograms is key to early detection when cancer is most treatable. Improving screening rates and minimizing treatment delays have led to declining mortality rates for breast cancer.
Us breast cancer therapy market opportunity analysisRajesh Sarma
"US Breast Cancer Therapy Market Opportunity Analysis" Report Highlight:
US Breast Cancer Incidence & Prevalence
US Breast Cancer Therapy Market Overview
US Breast Cancer Drug Clinical Pipeline by Company & Phase
US Breast Cancer Drug Clinical Pipeline: 251 Drugs
Majority Drugs in Phase-II Trials: 73 Drugs
Marketed Breast Cancer Drugs in US: 32 Drugs
Breast Cancer Patent Analysis
This document discusses genetic cancer risk assessment and precision therapy approaches. It provides information on genes associated with increased risks of breast and ovarian cancer like BRCA1 and BRCA2. It summarizes lifetime cancer risks for mutation carriers and risk-reducing strategies. The document also covers multigene panel testing, challenges in interpreting results, and implications for surveillance and treatment. Advances in sequencing technologies have improved genetic testing but also require specialized expertise to apply testing and counseling appropriately.
This document discusses cancer risks associated with hereditary cancer syndromes like BRCA1/2 mutations and HNPCC. It provides lifetime risk percentages for various cancers in mutation carriers compared to the general population. It describes screening and prevention strategies like surveillance, chemoprevention, and prophylactic surgery that can reduce cancer risk. Genetic testing considerations and the importance of informing at-risk relatives is also covered.
This document summarizes a presentation on recurrent ovarian cancer given by Dr. Sarah Adams. It discusses the likelihood of recurrence based on initial cancer stage, common symptoms of recurrence, methods for diagnosing recurrence including physical exam, CA125 levels, and imaging, and treatment options based on platinum sensitivity including surgery, chemotherapy regimens, targeted therapies, and clinical trials. It also describes a 2010 European study that found initiating treatment earlier based on a CA125 doubling led to longer treatment-free intervals and improved overall survival compared to delayed treatment until symptom recurrence.
This document discusses hereditary breast and ovarian cancer syndrome, which is caused by mutations in the BRCA1 and BRCA2 genes. Carriers of these mutations have significantly increased risks of developing breast cancer and ovarian cancer. The document provides estimates of cancer risks associated with BRCA1 and BRCA2 mutations and discusses clinical management recommendations, including who should be referred for genetic counseling and testing. Genetic counseling is important to discuss test results, cancer risks, and risk reduction options like increased screening and preventative surgeries.
This document summarizes a study examining the expression of BRCA1 and BRCA2 genes in premenopausal Mexican women with breast cancer. The study analyzed 62 premenopausal women under age 45 with breast cancer to evaluate the clinical and immunohistochemical correlates of BRCA1 and BRCA2 mRNA expression. Low levels of BRCA1 expression were associated with younger patient age and more advanced clinical stage, but BRCA2 expression did not correlate with disease severity. Neither gene expression correlated with tumor characteristics like histology, differentiation, metastasis, or markers like p53 and HER-2.
This document discusses genetic counseling for cancer risk assessment. It begins with an introduction to Sandra Brown and her role as manager of the Cancer Genetics Program. It then provides information on various genes associated with cancer risks and how damage to these genes can cause uncontrolled growth and malignant tumors. The rest of the document discusses the differences between sporadic, familial, and inherited cancers; the process of genetic counseling before and after genetic testing; recommendations for who should receive genetic counseling; challenges like interpreting results and informing family; and current issues and controversies in cancer genetics.
This document discusses ovarian cancer research and clinical trials. It provides an overview of ovarian cancer subtypes and gene mutations associated with serous cancer. It also summarizes various drug targets and clinical trials being studied for ovarian cancer treatment, including PARP inhibitors, Akt inhibitors, angiogenesis inhibitors, monoclonal antibodies, immune therapies, vaccines, and CAR-T cells. Challenges in ovarian cancer research like intra-tumor variability and the complexity of genetics are discussed. The importance of patient participation in clinical trials to advance scientific progress is emphasized.
Tumour Markers are substances present in the tumour, produced by the tumour or by the host as a response to the presence of the tumour, providing information about biological characteristics of the tumour. these tumour markers may specific for the tissue but often get elevated in neoplastic as well non-neoplastic lesions, further Various analytical platforms available for serum tumour markers lack standardisation. These factors add to interpretative challenges in serum tumour markers
BRCA – Importance in Hereditary Breast & Ovarian CancerLifecare Centre
BRCA – Importance in Hereditary
Breast & Ovarian Cancer
DGF & WOW India
presentation was made by
Dr Sharda Jain
based on presentation made by
Dr Sunil Tadepalli
This study evaluated the association between preoperative serum CA-125 levels and clinical pathological characteristics in 87 women with endometriosis. The study found significant correlations between higher CA-125 levels and more advanced endometriosis stage, larger lesion size, and higher adhesion scores. However, there were no significant associations between CA-125 levels and age, marital status, patient complaints, or pelvic pain scores. The study suggested CA-125 cut-off levels of 37 U/ml for premenopausal patients and 35 U/ml for postmenopausal patients to help determine if surgery is needed.
Oncotype DX is a 21-gene diagnostic test developed by Genomic Health to analyze gene expression in breast cancer tumors. It provides a Recurrence Score that quantitatively estimates the likelihood of cancer recurrence and predicts whether chemotherapy will provide benefit. The test analyzes the expression of 16 cancer-related genes and 5 reference genes using RT-qPCR. Validation studies have shown the Recurrence Score strongly correlates with actual cancer recurrence. While approved through CLIA, Genomic Health is also pursuing FDA approval and expanding the test to other cancers.
- Three major molecular assays have been developed for prognostic assessment of breast cancer: Oncotype DX, Mammaprint, and Prosigna.
- Oncotype DX uses a 21-gene signature to predict recurrence risk in ER+ breast cancer. Mammaprint uses a 70-gene signature and Prosigna uses the PAM50 intrinsic subtyping algorithm.
- Clinical trials have validated the use of these assays in lymph node positive and negative disease to predict chemotherapy benefit and guide treatment decisions. Ongoing research aims to further refine risk assessment and subclassify breast cancer.
ROMA is a risk stratification tool that uses a patient's levels of HE4, CA125, and menopausal status to provide a numerical score indicating their risk of having ovarian cancer. The score is derived through an established formula and classifies a patient as either high or low risk. Studies show ROMA correctly identifies 94% of ovarian cancers and has superior performance over single biomarker tests in assessing cancer risk. However, it is not intended as a standalone diagnostic and still requires clinical evaluation.
Breast cancer is the most common cancer among American women (American Cancer Society), but only 5-10 percent of breast cancer cases are hereditary. Of those cases, roughly 20-25 percent are linked to mutations in the BRCA1 and BRCA2 genes (BRCA stands for BReast CAncer susceptibility). View the infographic above for more on the genetics of breast cancer.
For more information on breast cancer, visit the website for Dana-Farber’s Susan F. Smith Center for Women’s Cancers Breast Oncology Program: http://www.dana-farber.org/Adult-Care/Treatment-and-Support/Breast-Cancer.aspx
This document provides a guide to understanding BRCA1 and BRCA2 genes and managing cancer risks for carriers. It discusses background on the genes and associated cancer risks, screening and risk reduction options for breast and ovarian cancer, sharing genetic information with family, and other topics like insurance and family planning considerations. The key points are that BRCA1/2 carriers have high lifetime risks of breast and ovarian cancer, and screening and risk-reducing surgeries are options to help manage those risks, though neither prevent cancer. Genetic testing of relatives is also recommended to identify others who may benefit from similar risk management strategies.
A review of breast cancer in Saudi Arabia with an update on all aspects of breast cancer management including Diagnosis, Family History, Surgery (& Reconstructive Surgery), Sentinel Node Biopsy and Adjuvant Chemo, Radio and Hormone Therapy.
This document provides updates to guidelines for several types of cancer screening, including breast, colorectal, cervical, prostate, lung, and ovarian cancer. For each cancer, it discusses what screening tests are recommended, for which populations and age groups, and how frequently screening should occur. It also notes some controversial issues and new recommendations from groups like the US Preventive Services Task Force.
Via Christi 50+ Lunch and Learn: Can I prevent breast cancer?Via Christi Health
This document discusses breast cancer risks, prevention, and screening. It outlines risk factors such as age, family history, breast density, and lifestyle factors. Some risks cannot be reduced, but maintaining a healthy weight, exercise, limiting alcohol, and avoiding long-term hormone replacement therapy can potentially lower risk. Screening through mammograms is key to early detection when cancer is most treatable. Improving screening rates and minimizing treatment delays have led to declining mortality rates for breast cancer.
Us breast cancer therapy market opportunity analysisRajesh Sarma
"US Breast Cancer Therapy Market Opportunity Analysis" Report Highlight:
US Breast Cancer Incidence & Prevalence
US Breast Cancer Therapy Market Overview
US Breast Cancer Drug Clinical Pipeline by Company & Phase
US Breast Cancer Drug Clinical Pipeline: 251 Drugs
Majority Drugs in Phase-II Trials: 73 Drugs
Marketed Breast Cancer Drugs in US: 32 Drugs
Breast Cancer Patent Analysis
This document discusses genetic cancer risk assessment and precision therapy approaches. It provides information on genes associated with increased risks of breast and ovarian cancer like BRCA1 and BRCA2. It summarizes lifetime cancer risks for mutation carriers and risk-reducing strategies. The document also covers multigene panel testing, challenges in interpreting results, and implications for surveillance and treatment. Advances in sequencing technologies have improved genetic testing but also require specialized expertise to apply testing and counseling appropriately.
This document discusses cancer risks associated with hereditary cancer syndromes like BRCA1/2 mutations and HNPCC. It provides lifetime risk percentages for various cancers in mutation carriers compared to the general population. It describes screening and prevention strategies like surveillance, chemoprevention, and prophylactic surgery that can reduce cancer risk. Genetic testing considerations and the importance of informing at-risk relatives is also covered.
This document summarizes a presentation on recurrent ovarian cancer given by Dr. Sarah Adams. It discusses the likelihood of recurrence based on initial cancer stage, common symptoms of recurrence, methods for diagnosing recurrence including physical exam, CA125 levels, and imaging, and treatment options based on platinum sensitivity including surgery, chemotherapy regimens, targeted therapies, and clinical trials. It also describes a 2010 European study that found initiating treatment earlier based on a CA125 doubling led to longer treatment-free intervals and improved overall survival compared to delayed treatment until symptom recurrence.
This document discusses hereditary breast and ovarian cancer syndrome, which is caused by mutations in the BRCA1 and BRCA2 genes. Carriers of these mutations have significantly increased risks of developing breast cancer and ovarian cancer. The document provides estimates of cancer risks associated with BRCA1 and BRCA2 mutations and discusses clinical management recommendations, including who should be referred for genetic counseling and testing. Genetic counseling is important to discuss test results, cancer risks, and risk reduction options like increased screening and preventative surgeries.
This document summarizes a study examining the expression of BRCA1 and BRCA2 genes in premenopausal Mexican women with breast cancer. The study analyzed 62 premenopausal women under age 45 with breast cancer to evaluate the clinical and immunohistochemical correlates of BRCA1 and BRCA2 mRNA expression. Low levels of BRCA1 expression were associated with younger patient age and more advanced clinical stage, but BRCA2 expression did not correlate with disease severity. Neither gene expression correlated with tumor characteristics like histology, differentiation, metastasis, or markers like p53 and HER-2.
This document discusses genetic counseling for cancer risk assessment. It begins with an introduction to Sandra Brown and her role as manager of the Cancer Genetics Program. It then provides information on various genes associated with cancer risks and how damage to these genes can cause uncontrolled growth and malignant tumors. The rest of the document discusses the differences between sporadic, familial, and inherited cancers; the process of genetic counseling before and after genetic testing; recommendations for who should receive genetic counseling; challenges like interpreting results and informing family; and current issues and controversies in cancer genetics.
This document discusses ovarian cancer research and clinical trials. It provides an overview of ovarian cancer subtypes and gene mutations associated with serous cancer. It also summarizes various drug targets and clinical trials being studied for ovarian cancer treatment, including PARP inhibitors, Akt inhibitors, angiogenesis inhibitors, monoclonal antibodies, immune therapies, vaccines, and CAR-T cells. Challenges in ovarian cancer research like intra-tumor variability and the complexity of genetics are discussed. The importance of patient participation in clinical trials to advance scientific progress is emphasized.
Tumour Markers are substances present in the tumour, produced by the tumour or by the host as a response to the presence of the tumour, providing information about biological characteristics of the tumour. these tumour markers may specific for the tissue but often get elevated in neoplastic as well non-neoplastic lesions, further Various analytical platforms available for serum tumour markers lack standardisation. These factors add to interpretative challenges in serum tumour markers
BRCA – Importance in Hereditary Breast & Ovarian CancerLifecare Centre
BRCA – Importance in Hereditary
Breast & Ovarian Cancer
DGF & WOW India
presentation was made by
Dr Sharda Jain
based on presentation made by
Dr Sunil Tadepalli
This presentation talks about the nonconventional ways to look for cancer. It discusses next generation sequencing for multilane panels for cancer predisposition syndromes, whole genome sequencing, circulating tumor cells, circulating tumor DNA, and CancerSEEK. It also discusses the traditional cancer screening guidelines by the American Cancer Society and the USPSTF.
1. The document discusses the debate around prostate cancer screening in elderly men over age 65, with arguments on both sides.
2. Screening may detect cancers early that would not have progressed or caused harm in a man's lifetime given his life expectancy. However, screening also risks overdiagnosis and overtreatment of biologically unimportant cancers.
3. Guidelines in the US do not recommend routine screening for low-risk, elderly patients due to the scientific uncertainties around the balance of benefits and harms. Patient-clinician discussion is important to make informed, individual decisions.
This document discusses benign breast disease, risk factors for breast cancer, hereditary breast cancer syndromes, screening and surveillance for breast cancer, evaluation of breast symptoms such as lumps, nipple discharge, and abnormal mammogram findings. It provides guidelines for managing increased risk and evaluating various breast abnormalities to determine if biopsy or other follow up is needed.
Mon 8-00 Prostate Cancer Screening in the Post-USPSTF Era_0.pptxRonitEnterprises
This document discusses prostate cancer screening and recommendations. It begins with a case presentation of a 54-year-old man before discussing the US Preventive Services Task Force recommendations against PSA screening. It then reviews the goals of cancer screening, basics of PSA testing and prostate cancer, impact of the Task Force, and ways to improve screening through risk stratification using newer biomarkers, imaging, and genetic profiling to avoid overdiagnosis while identifying high-risk cancers.
1. The document discusses whether prostate cancer screening should be recommended for elderly men over age 65 given the high prevalence of prostate cancer but also the slow growing nature in many cases and short life expectancy.
2. While screening can detect cancer early, it also risks overdiagnosing biologically unimportant cancers and subjects men to potential harms of treatment without clear benefits due to their age.
3. Guidelines in the US have differing recommendations regarding screening older men, reflecting the ongoing debate around the balance of risks and benefits in this population.
Tumor markers can play roles in early detection, diagnosis, prognosis, monitoring treatment response, and detecting recurrence of certain cancers. This document discusses various tumor markers including their reference ranges, associated cancers, clinical applications, and methods of detection. Key points covered include the roles of AFP for liver cancer screening, CEA and CA19-9 for colorectal cancer monitoring, PSA for prostate cancer screening and follow up, and CA125 for ovarian cancer treatment assessment and recurrence detection. The document also provides recommendations for optimal use of tumor marker tests.
Audio and slides for this presentation are also available on YouTube: http://youtu.be/ukXhuy5cXrE
Huma Q. Rana, MD, a cancer geneticist with Dana-Farber Cancer Institute, explains the cancer risk associated with BRCA1 and BRCA2 gene mutations. This presentation was originally given on July 23, 2013 as part of the "What Every Woman Should Know" event put on by Dana-Farber's Susan F. Smith Center for Women's Cancers.
This document discusses genetic testing guidelines for breast and ovarian cancer. It provides an overview of current guidelines from organizations like USPSTF, NCCN, ACOG, and NICE. The USPSTF recommends testing only for those with a suggestive family history. NCCN guidelines provide more detailed criteria for testing breast cancer patients. Studies have found a high percentage (around 10%) of Ashkenazi Jewish women with breast cancer carry BRCA mutations, suggesting all such women should undergo genetic testing. Overall, the guidelines are evolving to expand testing to more patients as the therapeutic implications of mutations are better understood.
This document discusses tumor markers, which are biological substances that can indicate the presence of cancer. It describes several potential uses of tumor markers, including screening, diagnosis, prognosis, and monitoring treatment. Several specific tumor markers are mentioned, such as CA 15-3, CA 27-29, HER2, and hormone receptors. The document notes that an ideal tumor marker would be highly sensitive and specific, correlate with tumor stage and mass, and predict prognosis. However, no single marker is perfect, and research is ongoing to discover new markers and improved methods of detection such as genomics and proteomics.
All in the Family: Hereditary Risk for Gynecologic Cancerbkling
Knowing and understanding your inherited genetics is important for ovarian and uterine cancer patients. Dr. Melissa Frey, gynecologic oncologist at Weill Cornell Medicine, discusses how genetic factors affect women with ovarian and uterine cancer and influence treatment decisions, with a particular focus on BRCA1 & 2 and Lynch Syndrome.
This webinar was being put on in partnership with FORCE.
Prostate cancer screening and early detection is an ongoing area of research and debate. While screening can detect prostate cancer earlier when it may be more treatable, it also leads to overdiagnosis and overtreatment. Several large clinical trials have had conflicting results on the benefits of prostate cancer screening. Guidelines from organizations also vary in their recommendations for screening. New biomarkers and imaging techniques are being studied to improve screening specificity and reduce unnecessary biopsies and treatment. Overall, the effectiveness of prostate cancer screening remains uncertain, and any decision to be screened requires informed discussion of risks and benefits.
Breast cancer screening-2021 chan hio tongjim kuok
This document discusses breast cancer screening and provides guidance on screening strategies based on risk level. It covers:
1) Screening modalities like mammography, ultrasound, MRI and their limitations. Mammography is the primary screening tool for average risk women aged 50-74.
2) Risk assessment factors like family history, genetic mutations, breast density, reproductive history which determine screening frequency and additional tests. Women at high risk start screening earlier and more frequently.
3) Two case studies where mammography limitations are demonstrated. Early detection through clinical exams and additional tests led to cancer diagnosis in both cases. Regular screening tailored to risk level can improve early detection.
CA-125 is a protein marker that is elevated in many ovarian cancer patients. While it returns a true positive result in only 50% of stage I ovarian cancer, serial CA-125 testing over time can achieve a high specificity of 99.6%. Combining CA-125 testing with transvaginal ultrasound and examination increases accuracy for detection. HE4 is another protein marker that is elevated in epithelial ovarian cancer and not benign gynecological conditions. Using both CA-125 and HE4 tests in an algorithm called ROMA can help determine likelihood of malignancy in women with ovarian masses, outperforming CA-125 alone. ROMA and ultrasound are useful first-line tests to select high risk patients for referral and further diagn
Oncovue jorge power point presentation.ppt(2)mariuslehaci
OncoVue is a breast cancer risk assessment test that uses a multivariate logistic regression model incorporating 125 candidate gene SNPs and personal history measures to provide a more personalized risk estimation compared to existing models like Gail. The document describes the development of the OncoVue model through a case-control study genotyping over 20,000 individuals to identify genetic and personal risk factors. Validation studies showed OncoVue improved risk estimation over the Gail model, identifying up to 51% more high risk cases. OncoVue is now used in clinical settings to guide screening and prevention decisions.
Cervical cancer screening guidelines 2013 on 7th septLifecare Centre
The document summarizes the 2013 guidelines for cervical cancer screening in the United States. The key points are:
1. Screening should begin at age 21 with cytology alone every 3 years until age 30.
2. From ages 30-65, co-testing with cytology and HPV testing every 5 years is the preferred method. Cytology alone every 3 years is acceptable.
3. Screening can stop at age 65 for women with adequate negative prior screening and no history of CIN2 or worse. Screening after a hysterectomy also depends on whether the cervix was removed.
1) Breast cancer screening, particularly mammography, allows for early detection of breast cancer when it is smaller and more treatable. Mammography can find non-palpable cancers.
2) Early detection results in better survival rates, less need for chemotherapy, and allows for more breast-conserving surgeries.
3) Screening guidelines recommend annual mammograms starting at age 40-50 depending on risk factors. Additional tests like MRI may be used for dense-breasted or high-risk women.
1) Breast cancer screening, particularly mammography, allows for early detection of breast cancer when it is smaller and more treatable. Mammography can find non-palpable cancers.
2) Early detection results in better survival rates, less need for chemotherapy, and allows for more breast-conserving surgeries.
3) Screening guidelines recommend annual mammograms starting at age 40-50 depending on risk factors. Additional tests like MRI may be used for dense-breasted or high-risk women.
1) Breast cancer screening, particularly mammography, allows for early detection of breast cancer when it is smaller and more treatable. Mammography can find non-palpable cancers.
2) Early detection results in better survival rates, less need for chemotherapy, and allows for more breast-conserving surgeries.
3) Screening guidelines recommend annual mammograms starting at age 40-50 depending on risk factors. Additional tests like MRI may be used for dense-breasted or high-risk women.
Similar to Abviva, Inc. (PK ABVV) presentation OneMedForum-New York (20)
Can you stand out in the Sea of JP Morgan Healthcare Conference Suits?Chelli Miller
This document describes a JPM Investor Awareness Program that combines equity research with targeted digital investor outreach. The program includes distributing tearsheets with investment thesis and company data before JPM, posting about key discussion points the week before, and a marketing campaign with weekly custom posts to boost awareness. During JPM, it highlights meetings/presentations, posts the company presentation twice, and provides real-time analyst commentary. After JPM, it includes a wrap-up article, full report on impressions and engaged investors, and ongoing growth of social/media outreach aligned with IR strategy and recommendations for 2017. The fee for the 8-week program is $4K.
A medical student at Saba University shares their experience going on their first night dive in Saba. They saw many of the same fish they see during day dives but everything appeared different at night. With just a flashlight, it felt like they were investigating clues on a crime show. During the dive, they encountered a group of 6 nurse sharks swimming alongside them along with several stingrays and many other fish. The student encourages others with questions to contact them for more information about life as a medical student on Saba.
Another Year of Top Residencies for SabaChelli Miller
How well students do in obtaining residency appointments is a primary measure of success of a medical school and based on the 2016 results Saba continues its place as a leading international medical school.
Xchange reception @ JP Morgan Healthcare Conference Week!Chelli Miller
Join us during the JP Morgan Healthcare Conference Monday, January 12 from 6-9pm at 545 Powell Street, San Francisco for an opportunity to meet VC's, accredited investors and emerging companies!
AdvaMed2014 Invites mHealth to Chicago!Chelli Miller
Exclusive AdvaMed 2014 Conference Registration
Available only to Chicagoland Digital/mHealth Companies
mHealth credentials provide limited access to the conference on Tuesday, October 7 and Wednesday, October 8, 2014.
DEVELOPMENT OF ESSENTIAL SAMPLE PREPARATION TECHNIQUES IN PROTEOMICS USING UL...Chelli Miller
Alexander R. Ivanov
HSPH Proteomics Resource
Department of Genetics and Complex Diseases
Harvard School of Public Health
www.hsph.harvard.edu/proteomics
E-clinical providers are fighting to reposition and re-assert themselves amid changing customer needs...article by Peter Mansell, interviewing Steve Kent, President of Parexel and Laurence Birch, Chairman of DATATRAK International. www.Pharmatimes.com
B2B payments are rapidly changing. Find out the 5 key questions you need to be asking yourself to be sure you are mastering B2B payments today. Learn more at www.BlueSnap.com.
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Abviva, Inc. (PK ABVV) presentation OneMedForum-New York
1. Diagnostic and Therapeutic Innovation
Abviva, Inc.
402 East Gutierrez Street
Santa Barbara, CA 93101
t: 800.970.5870 | f: 800.970.5874
www.abviva.com
2. FORWARD LOOKING STATEMENTS
Statements in this presentation that are not strictly historical facts are
“forward looking” statements (identified by the words “believe”,
“estimate”, “project”, “expect” or similar expressions) within the meaning
of the Private Securities Litigation Reform Act of 1995. These statements
inherently involve risks and uncertainties that could cause actual results to
differ materially from the forward-looking statements. Factors that would
cause or contribute to such differences include, but are not limited to,
continued acceptance of the Company’s products and services in the
marketplace, competitive factors, changes in the regulatory environment,
and other risks detailed in the Company’s periodic report filings with the
Securities and Exchange Commission. The statements in this presentation
are made as of today, based upon information currently known to
management, and the Company does not undertake any obligation to
publicly update or revise any forward-looking statements.
3. Mammastatin Serum Assay
Breast Cancer Risk Assessment
Mammastatin Serum Assay (MSA)
MSA Is A Simple Blood Test
Clinical Studies Demonstrate Value
Patented Technology
Exclusive License
MSA Assay Developed
Commercialize Current MSA - CLIA
$3.3 Billion US Addressable Market
4. Mammastatin Serum Assay
Favorable PSA Assay Statistical Comparison
Negative Positive
Screening Test Sensitivity Specificity Predictive Predictive Accuracy
Value Value
Mammastatin Serum
Assay (MSA)
71% 86% 98% 25% 85%
Prostate-Specific
Antigen Assay (PSA)
68% - 80% 60% - 70% 98% 30% 67%
PSA Assay Statistical Performance References:
“Prostate-Specific Antigen (PSA) Best Practice Policy” Oncology Vo. 14, No 2 (February 6, 2000)
“Predictors of Prostate Carcinoma: Accuracy of Gray-Scale and Color Doppler US and Serum Markers” Radiology. 2001; 220: 757-764
“Prostate Screening – Learn More: Accuracy of the PSA Test” http://www.realage.com/health_guides/ProstateCancer/topics/fs_topics.asp?memberId=&cbr=&topic=23
5. Mammastatin Science
Science Of Mammastatin:
Normally Present In Healthy Women
Secreted From Breast Epithelial Cells
Inhibits Growth of Breast Cancer Cells
Detected In Peripheral Blood Serum
Published In Scientific Journals
Science 1989
IVD Technology – MSA – 2003
High Levels (Normal) ~ Low Risk
Low Levels (Not Normal) ~ High Risk
6. Mammastatin US Patent Portfolio
ISSUED US
PATENTS PATENT NAME
6,451,765 Methods for Treating Breast Cancer Using Mammastatin
6,492,504 Nucleotide Sequence of Mammastatin and Methods of Use
6,500,937 Nucleotide Sequence Encoding a Mammary Cell Growth Inhibitor
6,599,495 Nucleotide and Protein Sequence of Mammastatin and Methods of Use
7,256,277 Nucleotide and Protein Sequence of Mammastatin and Methods of Use
7,323,173 Methods for Treating Breast Cancer Using a Mammary Cell Growth Inhibitor
7,332,287 Methods and Compositions for Diagnosing Breast Cancer
7. Breast Cancer Screening Market
No Equivalent Risk Assessment Test Available Today
Simple, Cost Effective Broad-Based Population Screening
Global Market Potential:
US Target Market:
82 Million Women Over 30
500 Million Women Worldwide*
US Addressable Market:
Women > 30 Yrs. Getting Annual Mammograms
48 Million in US
Over $3.3 Billion US Addressable Market
Predictive Screening Growing In Popularity
Benefits Of Earlier Breast Cancer Detection:
Higher Survival Rate – Up To 98%
Reduction In Death Rate
Lower Health Care Costs
• Women With Access To Health Care
• National Health Interview Survey Public Use Data File 2005, National Center for Health Statistics, Centers for Disease Control and Prevention, 2006;
• American Cancer Society, Surveillance Research, 2007
• Breast Cancer Facts & Figures 2007 – 2008; American Cancer Society
• Algood et al. (2007) British Journal of Cancer
8. Breast Cancer Testing
Breast Type Use Benefits Disadvantages Cost
Cancer Test
Mammogram Diagnostic Identifies Masses For Screening Standard Radiation Exposure $100 - $150
Imaging Follow Up and Biopsy To Identifies Masses False Positives
Confirm Breast Cancer Difficult On Dense Breasts
Ultrasound Diagnostic Identify Masses For Follow Adjunct To Mammography Not Mammogram Substitute $150 - $450
Imaging Up and Biopsy To Confirm Preferred For Dense Limited Access Early In
Breast Cancer Breasts Adoption Cycle
Lower False Positive Rate
MRI Diagnostic Identifies Masses For High Resolution Radiation Exposure $1,000 - $1,500
Imaging Follow Up and Biopsy To Better Identification Many False Positives
Confirm Breast Cancer Pin-point accuracy Costly
BRCA-1; BRCA-2 Genetic Test – Positive result indicates Blood Test 1 in 800 people have gene $300 - $3,000
Blood Test mutations in BRCA gene Accurate if gene present Genetic Screening Issues
associated with breast Positive Indicates High Negative test does not rule
cancer predisposition Risk out breast cancer
Her-2/neu Tumor Marker- Indicates how aggressive Specific for Her-2/neu After Cancer Diagnosed $50 - $100
Blood Test breast cancer may be, and positive breast cancer < 12% of breast cancers
indicates Herceptin Rresponse to Herceptin Not adequate for screening
treatment Blood test
Oncotype Dx Test Estrogen Sets guidelines for hormone Indicates therapies if tumor Tissue Sample $3,500
Receptor Test therapy, and evaluates risk influenced by hormones Not adequate for screening
– Tissue Test of cancer recurrence Use After Cancer Diagnosed
Mammastatin Blood Test Measure mammastatin High Simple Blood Test Pre-Launch Assay $150
Serum Assay Levels = Low Risk Identify High Risk Women Early Clinical Validation
Low Levels = High Risk Efficacy Demonstrated Mammastatin Mechanism of
Universal Screening Action Uncertain
Access CLIA Only Test Today
Therapeutic Monitoring Initially Private Pay
Test for future mammastatin
drug
9. Commercial Development Timeline
2010 2011 2012 2013 2014 2015
Launch Current MSA Test
Retrospective Study
Commercial Launch
ASR Designation
Submit ASR Application
FDA Approval
Lab Partner & National Distribution
FDA MSA PMA
File PMA I (Mfn.) Start Clinicals
File PMA II (Data)
File Original PMA
FDA Approval
Insurance Reimbursement
International Distribution
FDA MSA Test Kit 510(k)
Test Kit Developed
Clinical Studies
File 510(k)
FDA Approval
10. Breast Cancer Diagnostic Test
Mammastatin Serum Assay (MSA)
Operating and Financial Targets*:
Revenue in 2nd Quarter 2011
Positive Cash Flow in 2011
Accelerated Growth Rate in Year 3
Year 5 Targets*:
+ $200 mm Revenue
Sustainable Double Digit Earnings
Market Value ~ 25 to 35 P/E Multiple
11. MSA Test Summary
Patented Breast Cancer Risk Assessment Diagnostic
Addresses Unmet Medical Need
Large Global Market Opportunity
Initial Diagnostic Technology Validated
Serum MSA Test Ready for Commercialization
Well Defined, Achievable Commercial Development
High Value Commercial Opportunity
12. Mammastatin Breast Cancer Therapy
Protein Present In Healthy Women
Secreted From Breast Epithelial Cells
Early Protein Replacement Therapy
29 Women Treated - Compassionate Use
Compelling Patient Results
Palliative Stage IV Breast Cancer Patients
Physical Health of Women Improved
Metastatic Tumor Reduction – Bone Scans
Lives Extended Months to Years
Women Survived On Therapy Until Study Ended
Up To Two+ Year Survival After Therapy Initiated
All Expired Within 6 Months After Studies Ended
13. Development Milestones
Re-Establish Biologic Activity In Cell Culture
Ablation Study - Same Monoclonal Ab As MSA Assay
Development Concurrent With MSA Development
Develop Recombinant Protein
Manufacturing Through Phase I/II
Complete Pre-Clinical Studies
Submit To FDA For Accelerated Status
Initiate Phase I/II Trials
14. Rationale For Rx Development
Published Research: Protein Secreted By Breast Epithelial Cells
Published Research: Strong Anti-Cancer Growth Inhibition
Human Dx Studies: Protein Normally Present In Women
Human Dx Studies: Protein Absent In Breast Cancer
Human Rx Studies: Compassionate Use on 29 Women
Human Rx Studies: Lives Extended During Therapy
Human Rx Studies: Metastatic Tumors Reduced (Bone Scan)
Physician Observations: Patient Overall Health Improved
Physician Observations: Placebo Effect Impossible
15. Commercial Stage Breast Cancer Risk Assessment
Breast Cancer Therapeutic Drug Demonstrated
Concomitant Therapeutic Monitoring Assay
Exclusive IP & Patent Protection
Diagnostic Products At Commercial Stage
Experienced Management
MSA Revenues in 2011 *
Address Large Global Markets & Unmet Needs
Large Capital Appreciation Potential
* Assumes Financing in Q3 2010
16. Corporate Structure and Management
Executive and Financial Management
Business Development
Financing and Liquidity
Breast Cancer Risk Assessment Diagnostic Incorporate In 2011
A Wholly Owned Subsidiary Develop Mammastatin Therapeutic Assets
Mammastatin Serum Assay Business
17. www.abviva.com
Abviva, Inc.
402 East Gutierrez Street
Santa Barbara, CA 93101
t: 800.970.5870 | f: 800.970.5874
www.abviva.com