Droplet Digital™ PCR Test Offered for Detection of SARS-CoV-2
BOULDER, Co.–(BUSINESS WIRE)–Biodesix, Inc., a leading diagnostic company in lung disease, today announced that it began SARS-CoV-2 Droplet Digital PCR (ddPCR) testing for the virus that causes COVID-19 and will immediately submit for Emergency Use Authorization from the Food and Drug Administration. Initially, Biodesix is receiving samples from local health systems, hospitals, and clinics in the state of Colorado. The Biodesix laboratory currently has the capacity to process 1,000 COVID-19 tests per day providing results in as little as 48 hours from the sample arriving at the laboratory. The sample for testing is collected by the patient’s healthcare provider and sent to the Biodesix CAP/CLIA/NYS CLEP approved Laboratory in Boulder, CO for processing.
Biodesix announced a partnership on March 20 with Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to bring a COVID-19 Droplet Digital PCR (ddPCR) test through the FDA to support the escalating need for testing in the U.S. The launch follows the publication of two studies,1,2 which reported that ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2, when compared to existing test methods that are performed using qPCR. The findings suggest that ddPCR testing can reduce false negative results of COVID-19 without any increase to false positive results and could be a powerful complement to the current standard of testing.
“Some of the most significant challenges that hospitals are dealing with are centered on testing and caring for patients suspected to have COVID-19. Hospitals are finding severe shortages of testing supplies and extended waits for test results3,” said Scott Hutton, CEO, Biodesix. “The Biodesix mission is always to be patient-centric and we felt compelled to use our technology and expertise in response to the devastating virus that causes COVID-19. It is our belief that introducing the most sensitive test possible will aid in stopping the spread of the virus as it will reduce the number of false negative test results.”
Biodesix is a leading diagnostic company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer five non-invasive tests for patients with diseases of the lung. Most recently Biodesix has launched the SARS-CoV-2 ddPCR™ test in response to the global pandemic and virus that impacts the lung and causes COVID-19. The blood-based Biodesix Lung Reflex® strategy for lung cancer patients integrates the GeneStrat® and VeriStrat® tests to support treatment decisions with results in 72 hours, expediting time to treatment. The blood-based Nodify Lung™ nodule risk assessment testing strategy consisting of Nodify XL2™ test and the Nodify CDT™ test evaluate the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. Biodesix also collaborates with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease. For more information about Biodesix, please visit www.biodesix.com.
Note Regarding Forward-Looking Statements
This press release may contain forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements contained in this press release other than statements of historical fact, are forward-looking statements. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “plan,” “expect,” “predict,” “potential,” “opportunity,” “goals,” or “should,” and similar expressions are intended to identify forward-looking statements. Such statements are based on management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors. Biodesix has based these forward-looking statements largely on its current expectations and projections about future events and trends. These forward-looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, Biodesix operates in a competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for its management to predict all risks, nor can it assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements it may make. Biodesix undertakes no obligation to revise or publicly release the results of any revision to such forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement.
Jordona Jackson Smith for Biodesix