This document provides information on biomarkers from GVK BIO's Clinical Biomarker Database (GOBIOM). It summarizes the types and numbers of biomarkers in the database categorized by indication, therapeutic area, specimen, and biomarker qualification. The largest numbers of biomarkers are for oncology and diseases of the circulatory system. Biomarkers are also categorized by their use for efficacy, diagnosis, safety, and other purposes. GOBIOM contains over 22,000 biomarkers and is being licensed by the US FDA to aid in their biomarker qualification process.

1. 17

2. Utility of Biomarkers
Efficacy
Diagnosis
Safety
Prognosis
Progression of Disease
Response To Therapy
Toxicity
Pharmacokinetic
Surrogate
Types of Biomarkers
9980
9424
Biochemical
Genomic
4577
4569
4000
6000
8000
10000
No of
Indications
16060
14370
6757
3585
1897
1739
1221
1056
517
516
423
364
347
331
252
246
238
218
Diseases of the circulatory system
144
103
Diseases of the digestive system
38
Infectious and parasitic diseases
47
Mental and behavioral disorders
45
Diseases of the respiratory system
34
Diseases of the skin and subcutaneous
tissue
Diseases of the eye and adnexa
10000
12000
14000
Biomarkers by Therapeutic Area
Oncology
Diseases of the circulatory system
1709
Endocrine, nutritional and metabolic diseases
1519
Diseases of the musculoskeletal system and …
1473
Diseases of the nervous system
1124
Others
1080
Diseases of the digestive system
946
Mental and behavioral disorders
891
Diseases of the respiratory system
822
Infectious and parasitic diseases
800
Diseases of the genitourinary system
583
Injury, poisoning and certain other … 266
Diseases of the skin and subcutaneous tissue
261
Diseases of the blood and blood -forming … 154
Diseases of the eye and adnexa
93
Diseases of the ear and mastoid process
4
10480
13
1
0
Others
2000
4000
6000
8000
10000
12000
1
Total
831
Biomarker Assays
Biomarker Qualifications
Total exp records
275710
No of biomarkers
22205
Clinical qualification
22205
7692
Analytical qualification
954
0
8000
18
Diseases of the ear and mastoid
process
Distinct Assays
6000
21
Injury, poisoning and certain other
consequences of external causes
No of biomarkers
4000
21
Diseases of the blood and bloodforming organs and certain disorders
involving the immune mechanism
100000
41
Diseases of the genitourinary system
80000
58
Diseases of the musculoskeletal system
and connective tissue
60000
48
Diseases of the nervous system
40000
2000
198
Endocrine, nutritional and metabolic
diseases
92016
372
0
12000
Therapeutic Area
35678
34460
20000
889
Imaging
Oncology
0
1074
Physiological
Biomarkers by Specimen
Tumor tissue
Serum
DNA
Plasma
Blood
RNA
Urine
Peripheral blood
Bone marrow
Cerebrospinal fluid
PBMC
Sputum
Bronchial alveolar lavage fluid
Synovial fluid
Scalp hair
Feces
mRNA
Lymphocytes
White blood cells
Tumor cells
Saliva
1801
Cellular
1333
855
101
59
2000
5461
Scoring scale
2771
0
12608
50000
100000
150000
200000
250000
300000
3951
0
5000
10000
15000
20000
25000

4. Press-Release
US FDA Extends License of the GVK BIO
Biomarker database
February 4, 2013: GVK Biosciences (GVK BIO) today announced that it is
extending its Clinical Biomarker Database (GOBIOM) license to the Biomarker
Qualification Group of the US Food and Drug Administration (USFDA). The
GOBIOM database, which has the latest and recently updated information on all
the biomarkers reported in various clinical and preclinical studies, will be
beneficial to the USFDA in its Biomarker Qualification Process.
The GOBIOM database is a comprehensive compilation of all the clinically
evaluated, exploratory and preclinical biomarkers associated with different
therapeutic areas reported in global clinical trials, clinical and preclinical studies.
GOBIOM contains information on 20,000 biomarkers comprising of biochemical,
genomic, imaging, metabolite, cellular and physiological markers, along with
multiple data points comprising of experimental, analytical, clinical and statistical
data with their qualifications under different medical interventions.
Sreeni Devidas, Vice President, Sales & Marketing, Informatics said “The
collaboration with the USFDA has helped GVK BIO in developing the safety
biomarker content in GOBIOM. The interconnectivity between organ toxicities to
the drug, dose and population was developed with equal emphasis on its
preclinical qualification. Biomarker analysis tools were integrated into the
database in a manner that has facilitated the user to make a comparative
analysis between the biomarkers of their interest. We look forward to continue
working and collaborating with the FDA with a view to enhancing the utility of the
product further.”
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