Biodesix Announces New Data Demonstrating Analytic Validity of Automated RNA Extraction from Plasma with the GeneStrat® Test

Study results demonstrate equivalency between manual and automated  RNA extraction platforms

Biodesix^® announced data demonstrating that a novel, automated method for extracting circulating RNA from plasma performed equivalently or better than the established manual method that is currently used for the company’s GeneStrat^® test. The data, which resulted from a collaboration between Biodesix and Norgen Biotek, were shared in a poster session today at AMP2017, the annual meeting of the Association for Molecular Pathology.

“As molecular testing becomes the standard in oncology, automation will be increasingly important to help us maintain the high quality of our test results and continue to meet our industry-leading 72-hour turnaround time,” said Biodesix Vice President of Development and Operations, Gary Pestano. “The data presented at AMP2017 suggest that it is possible to automate testing without sacrificing performance. They represent one of many evaluations we are conducting to assess potential automation methods for the Biodesix Lung Reflex™ with both our GeneStrat and VeriStrat^® tests.”

The GeneStrat test is a blood-based genomic test for patients with lung cancer that can inform the use of targeted therapies; test results are available within 72 hours. 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 (ddPCR) platform.

In the study presented at AMP2017, “Development and Analytic Validation of An Automated Circulating RNA Extraction System Using a Laboratory Validated ddPCR Test Process” (Poster #TT49), Biodesix researchers utilized a commercially-available laboratory developed test (LDT) for EML4-ALK mRNA fusion variants as a reference assay to assess the performance of an automated solution for RNA extraction that was developed and optimized by Norgen Biotek.

Results suggest that the automated method performed at least equivalently to the established manual method on all measures in the study, including quality and yield of mRNA from analytic blood samples.

“These results are encouraging, and we look forwarding to conducting further evaluation to assess clinical utility of the automated platform,” said Pestano.

The AMP2017 poster is available on request.

About Biodesix

Biodesix^® is a molecular diagnostics company advancing the development of innovative, multi-omic blood tests in oncology to enable precision medicine. Biodesix discovers, develops and commercializes multivariate protein and genomic liquid biopsy 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 and with the Biodesix Lung Reflex™ testing strategy, for better therapeutic guidance, more accurate prognosis and enhanced disease monitoring to improve patient outcomes. At the forefront of personalized medicine, Biodesix is developing new 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.