TUCSON, Ariz., April 15, 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 they have entered into a commercial supply and collaboration agreement. Under the agreement, Accelerate Diagnostics will distribute the BioCheck MS-FAST, a fully-automated chemiluminescence immunoassay analyzer, along with BioCheck's SARS-CoV-2 tests for the detection of IgG and IgM antibodies. The agreement covers North America, Europe and the Middle East.
The BioCheck MS-FAST system and SARS-CoV-2 chemiluminescence-based tests are capable of processing blood, serum, or plasma samples in 30 minutes to detect antibodies that confirm exposure and potential immunity to COVID-19. BioCheck has applied to receive FDA's Emergency Use Authorization (EUA) for their SARS-Cov-2 tests.
"Serological testing for the detection of antibodies to COVID-19 plays a critical role in identifying patients who have likely developed some degree of immunity to the virus," stated Romney Humphries, Accelerate Diagnostics' Chief Scientific Officer. "The BioCheck SARS-CoV-2 tests will help determine which medical professionals can more safely serve on the front lines treating COVID-19 patients, as well as when it may be safe for recovered patients to resume normal activities."
Jack Phillips, Accelerate Diagnostics' Chief Executive Officer, also commented: "We are eager to play our part in the fight against this devastating virus. BioCheck, Inc., in conjunction with its strategic partner Sophonix Co., Ltd., has been clinically validating its fully automated serologic tests in Wuhan, China since the early stages of the pandemic, and we are delighted to partner with them to bring this critical technology to as many patients and healthcare workers as possible."
Dr. Amy Zhang, Vice President and General Manager of BioCheck, stated: "We are excited to announce this partnership with Accelerate Diagnostics, which will bring our MS-FAST instrument and SARS-CoV-2 IgG and IgM tests to patients across multiple geographies and help prevent the further spread of COVID-19 around the world. Working with Sophonix, we have spent seven years developing the MS-FAST system to be more sensitive and easily deployable than many current products on the market."
Accelerate Diagnostics management will provide further details on the agreement during its first quarter earnings call scheduled for Thursday, May 7, 2020 at 4:30PM Eastern Time. Dial-in and webcast information for the earnings call can be found at ir.axdx.com.
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.
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"). Examples of forward-looking statements include our estimate of first quarter 2020 net sales, and any implication that consumable kit revenue will prove to be durable and predictable in the future, particularly during this unprecedented pandemic. Actual results or developments 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.