17

Types of Biomarkers

Biomarker Assays

Utility of Biomarkers

Biomarker Qualifications

Therapeutic AreaNo of

Indications

Oncology

Diseases of the circulatory system 144

Endocrine, nutritional and metabolic

diseases103

Diseases of the digestive system 48

Diseases of the nervous system 58

Diseases of the musculoskeletal system

and connective tissue41

Diseases of the genitourinary system 38

Infectious and parasitic diseases 47

Mental and behavioral disorders 45

Diseases of the respiratory system 34

Diseases of the skin and subcutaneous

tissue21

Diseases of the blood and blood-

forming organs and certain disorders

involving the immune mechanism

21

Diseases of the eye and adnexa 18

Injury, poisoning and certain other

consequences of external causes13

Diseases of the ear and mastoid

process1

Others 1

Total

59

101

855

1333

2771

4569

4577

9424

9980

0 2000 4000 6000 8000 10000 12000

Surrogate

Pharmacokinetic

Toxicity

Response To Therapy

Progression of Disease

Prognosis

Safety

Diagnosis

Efficacy

372

889

1074

1801

5461

12608

0 2000 4000 6000 8000 10000 12000 14000

Imaging

Physiological

Cellular

Scoring scale

Genomic

Biochemical

Biomarkers by Specimen

218

238

246

252

331

347

364

423

516

517

1056

1221

1739

1897

3585

6757

14370

16060

34460

35678

92016

0 20000 40000 60000 80000 100000

Saliva

Tumor cells

White blood cells

Lymphocytes

mRNA

Feces

Scalp hair

Synovial fluid

Bronchial alveolar lavage fluid

Sputum

PBMC

Cerebrospinal fluid

Bone marrow

Peripheral blood

Urine

RNA

Blood

Plasma

DNA

Serum

Tumor tissue

Biomarkers by Therapeutic Area

493

154261

266

583800

822891

9461080

11241473

1519

170910480

0 2000 4000 6000 8000 10000 12000

Diseases of the ear and mastoid process

Diseases of the eye and adnexa

Diseases of the blood and blood -forming …Diseases of the skin and subcutaneous tissue

Injury, poisoning and certain other …Diseases of the genitourinary system

Infectious and parasitic diseasesDiseases of the respiratory system

Mental and behavioral disorders

Diseases of the digestive systemOthers

Diseases of the nervous systemDiseases of the musculoskeletal system and …

Endocrine, nutritional and metabolic diseasesDiseases of the circulatory system

Oncology

954

22205

275710

0 50000 100000 150000 200000 250000 300000

Distinct Assays

No of biomarkers

Total exp records

3951

7692

22205

0 5000 10000 15000 20000 25000

Analytical qualification

Clinical qualification

No of biomarkers

198

831

6.1

20

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.”