Biodesix, Inc. Release: Clin-TOF Successfully Integrated Into VeriStrat Workflow

BOULDER, Colo.--(BUSINESS WIRE)--Study results presented today demonstrate the feasibility of running the VeriStrat^® test on Bioyong’s Clin-TOF platform, and provide a basis for validating and deploying a version of the VeriStrat^® test in Greater China. The data were presented in a poster at the ninth annual conference of the Association for Mass Spectrometry: Applications to the Clinical Lab (MSACL) in Palm Springs, California.

“We are happy that our Clin-TOF platform has passed Biodesix’s strict qualification requirements”

Biodesix (Boulder, CO, USA) and Bioyong Technology Company, Ltd. (Beijing, China) announced earlier this month that they have entered into an agreement whereby Bioyong will develop and commercialize a version of Biodesix’s VeriStrat^® proteomic blood test for clinical use in Greater China, with potential expansion into other Asia-Pacific countries.

For the study, Bioyong’s Chinese FDA (CFDA)-cleared MALDI-TOF device was integrated into the VeriStrat^® assay workflow. Biodesix used the same tiered qualification approach that it employs in its CLIA/CLEP-certified laboratory to analyze multiple sample sets with the Clin-TOF instrument. Across a total of 87 samples, concordance was 100%.

“The data from this study show that Bioyong’s Clin-TOF generates high-quality spectra and can support the VeriStrat^® assay,” said Biodesix senior scientist Nicholas Dupuis, Ph.D. “Based on these results, we are confident of validating a version of the VeriStrat^® test for the China market.”

“We are happy that our Clin-TOF platform has passed Biodesix’s strict qualification requirements,” said Dr. Ma, the founder and chairman of Bioyong. “This positive result gives us confidence that our plan to bring a version of the VeriStrat^® test into clinical use in Greater China will be successful.”

With nearly 850,000 new lung cancer diagnoses predicted in 2020, China represent approximately 37% of new cases expected worldwide.

Poster title: Integration of the Clin-TOF into the VeriStrat^® clinical testing workflow to generate serum protein profiles for prognosis and therapeutic guidance in NSCLC

Authors: Alex Nickel¹, Qingwei Ma², Maximillian Steers¹, Nicholas F. Dupuis¹ and Gary A. Pestano¹

Institutions: 1. Biodesix, Inc. 2970 Wilderness Place, Boulder CO 80301, 2. Bioyong Technologies Co. Ltd., Beijing, China

Poster Presentation: January 26, 2017, 10:00AM; Poster #41D.

A copy of the poster can be accessed at: http://www.biodesix.com/wp-content/uploads/2017/01/MSACL_BDX-Bioyong_23Jan17.pdf

About the VeriStrat^® test:

Biodesix’s VeriStrat^® test is a predictive and prognostic blood-based proteomic test for patients with non-small cell lung cancer. The test is used to assess disease aggressiveness by characterizing host response to the tumor, classifying patients as either VeriStrat^® Good or VeriStrat-Poor.

About Biodesix

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.

About Bioyong

Bioyong Technology Company, Ltd. has dedicated itself to developing mass spectrometry technologies for more than a decade. With the only/unique CFDA approval of domestic MALDI platform so far, Bioyong has expertise in serum peptidomics, nucleic acid detection and microorganism identifications. These technologies can and have been applied extensively in the growing field of precision medicine in an attempt to improve both diagnosis and prognosis for patients with a broad range of diseases. We are working hard to make the world healthier.

For more information about Biodesix, please visit www.Biodesix.com.

For more information about Bioyong, please visit www.bioyong.com.