Biodesix, Inc., a leading diagnostic company in lung disease, today announced that it has collaborated with Bio-Rad Laboratories, Inc. (NYSE: BIO and BIOb) to launch a blood-based immunoassay-based test that identifies antibodies to SARS-CoV-2, the virus that causes COVID-19. The Platelia SARS-CoV-2 Total Ab test was granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) late last month, making it the first total antibody test to receive EUA from the FDA. Clinical evaluation demonstrated specificity greater than 99 percent and diagnostic sensitivity of 98 percent eight days after the onset of symptoms. Cross-reactivity testing demonstrated specificity of 100 percent with no reactivity against other interfering specimens including non-CoV-2 coronaviruses.
After infection with SARS-CoV-2, viral antigens stimulate the body's adaptive immune system to produce antibodies to fight the virus. The Platelia SARS-CoV-2 Total Ab test identifies if a patient has produced those antibodies.
“The Platelia SARS-CoV-2 Total Ab test helps clinicians determine if a patient has potentially been infected by SARS-CoV-2 and therefore has developed an immune response against the virus,” said Scott Hutton, Chief Executive Officer of Biodesix. “This gives us a more complete understanding of infection rates as well as potential immunity, which will be vital information as we continue working to stop the spread of COVID-19.”
The Platelia SARS-CoV-2 test requires collection of a blood sample, which is sent to the CLIA-certified laboratory in De Soto, Kansas, for processing. Results will be delivered in 24 hours. Biodesix currently has the capacity to process 14,000 tests a day. The Platelia SARS-CoV-2 Total Antibody test can be utilized in combination with the SARS-CoV-2 Droplet Digital PCR (ddPCR) test to diagnose symptomatic patients and assess immunity in the population.
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 the Nodify XL2™ test and the Nodify CDT™ test evaluates 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200519005370/en/