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Who we are
- 1. Our vision enabling effective cancer treatment sooner Over a million estimated annual new cancer patients in the US Founder’s family member after completing treatment for breast cancer, Fall 1982 Breast 226,870 Prostate 241,740 Pancreatic 43,920 Other 1,126,380
- 2. Problem trial and error chemotherapy 62% of oncologists say their greatest unmet clinical need is “help with choosing the right therapy” Frost & Sullivan 2011
- 3. Opportunity identify the right treatment beforehand First time chemotherapy BIOARRAY test Effective drug Better response rate Less ineffective treatments Better treatment decisions Lower treatment costs
- 4. Discovery approach: confront “cancer in reverse”
- 5. 5 How others are trying to do it . . . Most studies focus on the unhealthy and compare supervised patient populations . . . but • cancer is complex • cancer cells are disorganized and become disorganized in many different ways • disorganization creates noise • noise makes it hard to identify important genes • limited to specific patient set and chemotherapy
- 6. BIOARRAY’s approach is to confront “cancer in reverse” To find predictive genes, BIOARRAY focused on healthy cell organization. • based on underlying biology • not limited to specific patient population or chemotherapy “[Sidney Farber’s] strategy . . . was to approach the disease from the normal to the abnormal—to confront cancer in reverse.” --The Emperor of All Maladies
- 7. BIOARRAY’s technology leverages the study of “cancer in reverse” Genes identified in healthy cells are informative about cancer cells Healthy Unhealthy BIOARRAY has developed a proprietary discovery platform that leverages the biology of the normal process of cell organization and advanced mathematics to identify novel putative cancer genes.
- 8. Fournier, et al., 2006, Cancer Research 66: 7095-7102; Martin et. al. 2008, PLoS ONE In vivo 3D-culture healthy breast acini Red: nuclei Green:α6-integrin “Cancer in reverse” approach uses healthy cell organization to identify cancer markers Similar phenotypes in vivo and 3D-culture 75Day: 3 Data.001 0 200 400 600 800 1000 FL2-H S=7.8% Data.002 0 200 400 600 800 1000 FL2-H S=15.7% Data.004 0 200 400 600 800 1000 FL2-H S=1.9% healthy acini organization in 3D-culture Growth arrested Basal polarity Hollow lumen Proliferating Unpolar No lumen Proliferating Unpolar No lumen gene expression by Affy chip RNA markers informative about breast cancer outcomes p = 9.41E-10 Gene expression like acini
- 9. Markers of healthy cell organization stratify cancer patients by prognosis Kaplan Meier curves Relapseprobability(%) Time to relapse (months) p = 0.000013 like acini Survival time (months) Survivalprobability(%) p = 0.0447 like acini Author, year Van de Vijver, 2002 Journal New Engl J Medicine # of patients 295 Chemotherapy Not specified Criteria Stage I or II invasive carcinoma patients < 52 years of age Endpoint Survival Sample type Frozen core biopsies Microarrays Rosetta arrays Author, year Wang, 2005 Journal Lancet # of patients 286 Chemotherapy None Criteria Lymph-node negative patients with no systemic therapy Endpoint Relapse Sample type Frozen core biopsies Microarrays Affymetrix HG-U133A Author, year Sorlie, 2003 Journal PNAS # of patients 118 Chemotherapy Not specified Criteria Invasive carcinoma Endpoint Survival Sample type Frozen core biopsies Microarrays Custom spotted arrays 3 independent datasets – total 699 patients Fournier, et al. (2006) Cancer Research Fournier and Martin (2006) J Cell. Physiol. Martin, et al. (2008) PLoS One p = 9.41E-10 Gene expression like acini
- 10. BIOARRAY’s discovery approach can be applied to multiple types of cancer BIOARRAY’s patent-pending discovery approach uses healthy (normal) cell organization to identify cancer genes. BIOARRAY’s target genes represent key biological processes disrupted in cancer. BIOARRAY's technology can be applied to multiple type of cancers including breast, prostate, and pancreatic cancers. Debnath et al. Cell 2002. Fournier et al. Can Res 2006. Fournier et al. Can Res 2009. Breast Zhang, Fournier et al. Mol Can Ther 2009. Prostate Pancreas Other indications: colon, lung, melanoma Deramaudt, et al. Mol Cell Biol 2006.
Editor's Notes
- The principle hurdle in developing molecular diagnostics is usually finding the predictive biomarkers out of the 22,000 human genes.Rather than rely on bioinformatics and statistics alone, BIOARRAY uses an innovative approach that finds the best predictive genes by focuses on the genes that are important in the normal, healthy cell organization. The genes that are important to healthy cell organization act like surveillance cameras. We can use our surveillance cameras to provide information as tumor cells progress from organized healthy cells to disorganized cancer cells.By using a discovery approach based on a biological rationale, BIOARRAY test offers several advantages that have scientific and commercial consequences.BIOARRAY’s approach provides more accurate prediction. Moreover, because it is not limited to a particular patient population or chemotherapy, BIOARRAY’s test can predict response in multiple subtypes as well as to multiple chemotherapies. Finally, our approach can support multiple types of diagnostic tests for multiple cancers.
- Highly valuable, actionable information that
- BIOARRAY’s Response Prediction Test is a personalized diagnostic testthat will accurately predict whether a woman with breast cancer will or will not respond to chemotherapy.The BIOARRAY test is a molecular signature test—based on a multi-gene signature and proprietary algorithm—that predicts chemotherapy response.The BIOARRAY test works across multiple breast cancer subtypes, including the aggressive “triple negative” subtype which disproportionately affects younger women and for which there is no tests currently available.BIOARRAY’s test is accurate, quantitative, and cost-effective.By predicting whether a particular woman will response or not respond to chemotherapy treatment, BIOARRAY’s Response Prediction Test will benefit patients and reduce overall treatment costs.
- The BIOARRAY test will build upon already existing infrastructure.A biopsy is currently already done at the time of diagnosis. After diagnosis, but before treatment, a doctor will order the BIOARRAY test be performed. The biopsy will be shipped to BIOARRAY’s laboratory or a lab licensed by BIOARRAY in BIOARRAY supplied packaging. The lab will then extract RNA from the biopsy and conduct a PCR analysis for the relevant biomarkers. Analysis of the expression levels by BIOARRAY’s proprietary algorithm will yield accurate and quantitative information about whether a women will respond to chemotherapy.These results will be transmitted to the patient and her doctor in a secure, confidential, HIPA compliant manner.The test will be paid for through reimbursement by third party payers.
- The BIOARRAY test will build upon already existing infrastructure.A biopsy is currently already done at the time of diagnosis. After diagnosis, but before treatment, a doctor will order the BIOARRAY test be performed. The biopsy will be shipped to BIOARRAY’s laboratory or a lab licensed by BIOARRAY in BIOARRAY supplied packaging. The lab will then extract RNA from the biopsy and conduct a PCR analysis for the relevant biomarkers. Analysis of the expression levels by BIOARRAY’s proprietary algorithm will yield accurate and quantitative information about whether a women will respond to chemotherapy.These results will be transmitted to the patient and her doctor in a secure, confidential, HIPA compliant manner.The test will be paid for through reimbursement by third party payers.
- Specifically, we placed health cells in a 3D culture in a non-organized state. Over a week, the healthy cells will self-organize into a ring, known as an acini or lumen. At this point, the healthy cells stop replicating, have “polarity” or spatial awareness , and are structured. BIOARRAY identified the genes that were most important in healthy cells progression from a state of disorganization to a state of organization.Cancer cells are disorganized. Because of mutations they are heterogeneous. They no not stop replicating . They have no polarity or spatial awareness, and they do not organize into a structure. The 22 genes that BIOARRAY identified in studying healthy cells movement from a disorganized state to an organized state are also important in understanding a cancer cell’s reverse path—from healthy organized cells to cancerous disorganized cells.
- The BIOARRAY test will build upon already existing infrastructure.A biopsy is currently already done at the time of diagnosis. After diagnosis, but before treatment, a doctor will order the BIOARRAY test be performed. The biopsy will be shipped to BIOARRAY’s laboratory or a lab licensed by BIOARRAY in BIOARRAY supplied packaging. The lab will then extract RNA from the biopsy and conduct a PCR analysis for the relevant biomarkers. Analysis of the expression levels by BIOARRAY’s proprietary algorithm will yield accurate and quantitative information about whether a women will respond to chemotherapy.These results will be transmitted to the patient and her doctor in a secure, confidential, HIPA compliant manner.The test will be paid for through reimbursement by third party payers.
- Marcia and I, with the Bissell lab, have done a lot of work to study how well the 22 genes determine prognosis in breast cancer. I won’t go into details, except to say that we have looked at three independent datasets that include nearly 700 patients and the signature accurately determined prognosis in each. This work is published in the 3 sources listed here.Determination of prognosis is an aspect of the 22 gene test that we could build in later, but our initial objective is to develop a chemotherapy prediction test.