Biodesix Partners with Bio-Rad to Bring Emergency Use Authorization (EUA) COVID-19 ddPCR™ Test to the U.S.
Data show Droplet Digital™ PCR Test Can Detect COVID-19 with Greater Sensitivity and Precision
BOULDER, Colo.–(BUSINESS WIRE)–Biodesix, Inc., a leading diagnostic company in lung disease, today announced a partnership with Bio-Rad Laboratories, Inc. (NYSE:BIO) (NYSE:BIOb) to bring a COVID-19 Droplet Digital PCR (ddPCR) test to the FDA for an Emergency Use Authorization (EUA) approval to support the escalating need for testing in the U.S. Two studies published this month, ahead of peer review, reported that ddPCR testing showed superior sensitivity and precision for clinical detection of SARS-CoV-2 (the virus that causes COVID-19) compared to existing test methods that are performed using qPCR. Biodesix currently has a focus on lung disease and offers other diagnostic testing for lung cancer utilizing the ddPCR platform.
In the first study1, clinicians in Wuhan, China, observed that a subset of infected individuals who tested negative for COVID-19 using qPCR tested positive using ddPCR. The findings suggest that ddPCR 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.
The second study2, led by the National Institute of Metrology and provincial CDCs in China, also concluded that ddPCR significantly improves diagnostic detection accuracy of SARS-CoV-2 from 28.2% to 87.4%, thereby reducing false negatives.
Biodesix and Bio-Rad are working to gain the EUA approval to allow Biodesix to begin testing in the U.S. following that approval.
“Biodesix is committed to moving as quickly as possible to bring this COVID-19 test to the public,” said Scott Hutton, CEO, Biodesix. “By more quickly and more accurately identifying those who test positive for the virus, individuals can be quarantined or treated as quickly as possible, helping to contain the spread of COVID-19.”
The referenced articles are preprints and have not been peer reviewed. MedRxiv reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice. Articles on MedRxiv have not been finalized by authors, might contain errors, and report information that has not yet been accepted or endorsed in any way by the scientific or medical community.
Biodesix is a lung cancer diagnostic solutions company covering the continuum of patient care from early risk classification of lung nodules through treatment guidance in late stage cancer. The Company develops blood-based diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix is the first company to offer four non-invasive tests for patients with lung cancer or suspicious lung nodules. The 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 Nodify XL2TM test and the Nodify CDTTM 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. For more information about Biodesix, please visit www.biodesix.com.
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Jordona Jackson Smith for Biodesix