Objective is to increase access to testing
Gene By Gene, LTD., a world-leading CLIA accredited laboratory and provider of genetic testing services, today announced they will begin performing a diagnostic test to detect nucleic acid from the SARS-CoV-2 virus that causes COVID-19.
Gene By Gene’s test, a molecular-based assay that detects viral RNA in respiratory specimens, will be available for authorized healthcare providers in the U.S. to order beginning April 30th, 2020.
"We were confident we could answer the call for additional testing capabilities in the U.S. to help combat the spread of the COVID-19 outbreak," said Bennett Greenspan, president and CEO of Gene By Gene. "Thanks to the determination and swift action of our dedicated staff, including a team of highly experienced lab professionals, Gene By Gene will aid medical personnel in their efforts to quickly identify and treat patients who are ill through our quality testing services."
Gene By Gene will not collect respiratory specimens on suspected COVID-19 cases. Specimens processed at Gene By Gene’s Level II Biosafety Laboratory are required to have been collected by a qualified healthcare professional in a suitable environment such as a healthcare facility or physician’s office. Patients with questions concerning the appropriate way to provide Gene By Gene with a specimen for testing should consult with a physician.
The test is designed to provide patient results in less than 24 hours of a specimen arriving at the Gene By Gene lab. They expect to scale sample processing to 7,000 tests per week in May. Authorization will only be for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The company is strictly following all CDC and FDA guidelines for assay validation and implementation. The RNA test has been developed and validated and is being performed by Gene By Gene, but FDA’s review under emergency use authorization (EUA) is pending.
This test has not been FDA cleared or approved; however, this test has been authorized by FDA under an EUA for use by authorized laboratories. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
More information about Gene By Gene’s response to COVID-19 can be found at www.genebygene.com/coronavirus-covid-19/.
ABOUT GENE BY GENE
Gene By Gene is a world leader in genetic testing services with over 20 years of experience. Our laboratory holds accreditation from multiple agencies, including CAP, CLIA, New York State Department of Health, California Department of Public Health, and AABB. With a cutting-edge laboratory and highly trained team of experts, we are committed to excellence in the field of genetic analysis. To learn more about Gene By Gene, visit www.genebygene.com.
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