Accelerate Diagnostics Announces FDA Emergency Use Authorization for COVID-19 Individual IgM and IgG Antibody Tests
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TUCSON, Ariz., Sept. 10, 2020 /PRNewswire/ -- Accelerate Diagnostics, Inc. (NASDAQ:AXDX) and BioCheck, Inc., a privately-held San Francisco-based company focused on in vitro diagnostics, today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the individual BioCheck SARS-CoV-2 IgM Test Kit and the BioCheck SARS-CoV-2 IgG Test Kit. Today's announcement follows the recent EUA approval of the fully automated MS-Fast instrument and the BioCheck SARS-CoV-2 IgM and IgG Combo Test.
In accordance with the previously disclosed commercial supply and collaboration agreement, Accelerate Diagnostics will market, commercialize, and support this serology-based testing platform. The MS-Fast system and BioCheck SARS-CoV-2 chemiluminescence tests are capable of processing human serum samples in 30 minutes to detect antibodies that indicate recent or prior COVID-19 infection. Jack Phillips, Accelerate Diagnostics' Chief Executive Officer, commented, "Offering the individual BioCheck SARS-CoV-2 IgM and IgG tests alongside the BioCheck SARS-CoV-2 IgM and IgG Combo Test will provide our customers with the flexibility to meet their specific testing needs. We're tremendously excited to offer this accurate, high-quality antibody testing technology to our customers, as we believe the adoption of serology-based COVID-19 antibody testing will be an increasingly important tool in the fight against COVID-19." BioCheck's SARS-CoV-2 tests target the S1 protein, which has the fewest similarities to other coronaviruses and allows for a lower probability of false positives due to cross reactivity. The S1 protein is also the primary target for the leading COVID-19 vaccine candidates, which are being developed to neutralize antibodies that can block the virus from infecting healthy cells. For further information regarding the BioCheck SARS-CoV-2 IgM and IgG Combo Test, BioCheck SARS-CoV-2 IgM Test Kit or the BioCheck SARS-CoV-2 IgG Test Kit and fully-automated MS-Fast instrument, please visit the Accelerate Diagnostics website at https://acceleratediagnostics.com/sars-cov-2. About Accelerate Diagnostics, Inc. Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. The Accelerate Pheno® system and Accelerate PhenoTest® BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. The FDA cleared system and kit fully automate the sample preparation steps to report phenotypic antibiotic susceptibility results in approximately 7 hours direct from positive blood cultures. Recent external studies indicate the solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier. The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and "ACCELERATE PHENOTEST" and diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc. For more information about the company, its products and technology, or recent publications, visit axdx.com. About BioCheck, Inc. Since 1997, biotechnology company BioCheck, Inc. has been engaged in the development and manufacturing of high-quality in vitro diagnostic test kits for the worldwide biomedical, pharmaceutical, and scientific research markets under cGMP and ISO 13485 standards. BioCheck is commercializing the MS-FAST analyzer (automated chemiluminescent immunoassay system) and associated Covid-19 and other cytokine, metabolic, and cardiovascular test kits to allow convenient, instant, and accurate diagnosis of disease markers with a bench top instrument. In addition, the company also develops ultra-sensitive assays using Simoa™ technology (single molecule array), a powerful tool for detecting low-abundance biomarkers. Forward-Looking Statements This press release contains forward-looking statements, which are subject to risks and uncertainties, including those described in our periodic reports and other filings with the U.S. Securities and Exchange Commission (the "SEC"). Such forward-looking statements include Mr. Phillip's statement that we believe the adoption of serology-based COVID-19 antibody testing will be an increasingly important tool in the fight against COVID-19. Actual results or developments, including customer demand for the BioCheck SARS-CoV-2 IgM and IgG Combo Test, BioCheck SARS-CoV-2 IgM Test Kit or the BioCheck SARS-CoV-2 IgG Test Kit and fully-automated MS-Fast instrument, may differ materially from those projected or implied in these forward-looking statements. Anticipated results only reflect information available to us at this time and may differ from actual results. Information about the risks and uncertainties faced by Accelerate Diagnostics is contained in the section captioned "Risk Factors" in the company's most recent Annual Report on Form 10-K, filed with the Securities and Exchange Commission on February 28, 2020, and in any other reports that we file with the Securities and Exchange Commission from time to time. Except as required by federal securities laws, we undertake no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies.
SOURCE Accelerate Diagnostics, Inc. |
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Company Codes: NASDAQ-SMALL:AXDX |
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