June 12, 2017, Boulder, Colorado…Biodesix, Inc. (Boulder, CO, USA) and Positive Bioscience (Mumbai, India) announced today that they have entered into an agreement where Positive Bioscience will make Biodesix’s GeneStrat® and VeriStrat® liquid biopsy tests for non-small cell lung cancer (NSCLC) patients available in India. All testing will be performed at Biodesix’s CLIA/CAP/CLEP/ISO certified laboratory in Boulder, Colorado, USA.
“We are excited by the revolution in personalized medicine and we intend to be the leaders in this field in India. This partnership will provide lung cancer patients in India with access to critical liquid biopsy tests for the first time, enabling the highest standard of care. Every year thousands of Indian patients will benefit,” said Samarth Jain, Positive Bioscience CEO. “Through its industry-leading turnaround time, Biodesix’s tests will also accelerate time to treatment.”
With a population of 1.34 billion, India is the second most populous nation in the world and represents 18% of the global population. Lung cancer is the most commonly diagnosed cancer and is also the most common cause of cancer mortality in men. Through this partnership with Positive Bioscience, Biodesix is taking a major step towards making its liquid biopsy tests available to a larger portion of the world’s lung cancer patients.
The VeriStrat test is a predictive and prognostic blood-based proteomic test. The test is used to assess disease aggressiveness by characterizing host response to the tumor, classifying patients as either VeriStrat-Good or VeriStrat-Poor. A recent publication on the phase III LUX-Lung 8 study by Gadgeel et al. concluded that “…VeriStrat classification could be considered in patients with NSCLC of both squamous and non-squamous histology, including patients with wild-type or unknown EGFR mutation status, as it may guide treatment decisions.”2,3 These findings are consistent with the PROSE study where Gregorc et al. concluded that VeriStrat “serum protein test status is predictive of differential benefit in overall survival for erlotinib versus chemotherapy in the second-line setting.”4
The GeneStrat test is a blood-based genomic test for patients with lung cancer that can inform the use of targeted therapies. The test delivers results for EGFR sensitizing; EGFR resistance (T790M), KRAS, and BRAF mutations; and EML4-ALK, ROS1 and RET fusion variants. The liquid biopsy test measures circulating tumor DNA and RNA with a highly-sensitive droplet digital PCR platform.5
“Our centralized testing approach enables rapid and high quality test results within 4 days for Indian patients, well in advance of the 10-14 day average turnaround time for tissue-based testing”, said David Brunel, CEO. “We are very happy to be able to offer our tests to cancer patients in India through this partnership with Positive Biosciences.”
Terms of the agreement were not disclosed. This is the third international agreement that Biodesix has announced this year; the company entered into a collaboration with Beijing-based Bioyong Industries in January and a distribution agreement with Progenetics of Israel in March.
GeneStrat, VeriStrat, Biodesix Lung Reflex and Biodesix are registered trademarks of Biodesix, Inc. All other trademarks referenced herein are the property of their respective owners.
Biodesix® is a molecular diagnostics company advancing the development of innovative blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic diagnostic blood tests, including the GeneStrat® and VeriStrat® tests, that deliver results within 72 hours. The company is changing the standard of care by providing physicians with diagnostic tests for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of precision medicine, Biodesix is developing new blood tests to identify patients who may benefit from immunotherapies. In addition to developing novel diagnostics independently, the company partners with biotechnology and pharmaceutical companies to develop companion diagnostics for use with therapeutic agents.
For more information about Biodesix, please visit www.Biodesix.com.
About Positive Bioscience
Positive Bioscience is India’s leading clinical genomics company in the cancer genomics and personal genomics space. PositiveSelect is India’s most widely-used cancer genomics test. Positive Bioscience is the exclusive partner for Myriad Genetics and Caris Life Sciences in India. Co-founded by Samarth Jain, Bapsy Jain and Dr. Meetha Medhora, Positive Bioscience aims to make genomic testing technology widely accessible in India. Positive Bioscience vision is to increase the life expectancy, work towards providing risk assessment for disease occurrence, preventive healthcare and personalised medicine. Positive Bioscience has opened India’s first Personal Genomics clinic in partnership with Medanta hospital, a landmark event in Indian healthcare.
 Lung Cancer: Prevalent Trends & Emerging Concepts. Indian J Med Res. 2015 Jan; 141(1): 5–7.
2 Gadgeel, Shirish, et al. "Evaluation of the VeriStrat® serum protein test in patients with advanced squamous cell carcinoma of the lung treated with second-line afatinib or erlotinib in the phase III LUX-Lung 8 study." Lung Cancer (2017).
3 Goss, G., et al. "Evaluation of VeriStrat, a serum proteomic test, in the randomized, open-label, Phase 3 LUX-Lung 8 trial of afatinib versus erlotinib for the second-line treatment of advanced squamous cell carcinoma of the lung." Annals of Oncology 27.suppl 6 (2016): 1238P.
4 Gregorc, Vanesa, et al. "Predictive value of a proteomic signature in patients with non-small-cell lung cancer treated with second-line erlotinib or chemotherapy (PROSE): a biomarker-stratified, randomised phase 3 trial." The Lancet Oncology 15.7 (2014): 713-721.
5 Mellert, Hestia, et al. "Development and Clinical Utility of a Blood-Based Test Service for the Rapid Identification of Actionable Mutations in Non–Small Cell Lung Carcinoma." The Journal of Molecular Diagnostics 19.3 (2017): 404-416.