BIRMINGHAM, Ala., February 17, 2021 (Newswire.com) – Molecular Designs, an assay design company, has developed a PCR test capable of differentiating the UK variant of COVID-19. Studies show this variant is more contagious and rapidly spreading in the US.
Currently, to detect the UK variant, labs are having to sequence the viral genome from positive SARS-CoV-2 tests. Genomic sequencing is an expensive and slow process with few labs having the required equipment and expertise to facilitate. On Jan. 25, 2021, the CDC announced they were “scaling-up” their sequencing capabilities to handle up to 750 samples per week.
Assurance Scientific Laboratories is currently validating the test for clinical use and it could be available by the end of the month. Assurance continues to work with the FDA and will submit for authorization under Assurance’s existing FDA Emergency Use Authorization (EUA).
“There are four signature mutations in the UK variant that our test targets. Robust amplification with our new test, represents the presence of the UK variant in the patient sample,” states Greer Massey, Ph.D., Chief Scientific Officer for Assurance Scientific Laboratories.
Assurance began working on the UK variant well before the lesser-known South African and Brazilian variants were well characterized. This test for the UK variant can be used in conjunction with other SARS-CoV-2 tests to determine if the UK variant is the SARS-CoV-2 strain detected. Work is also underway at Assurance to identify the South African and Brazilian variants.
“We want to use this test as soon as possible, but the test must first pass the rigors of clinical validation to prove it reliably and consistently works,” states Greer Massey, Ph.D., Chief Scientific Officer for Assurance Scientific Laboratories.
For more information or to speak to someone from Assurance Scientific Labs, contact Heather Jeffcoat by calling 205-515-1972 or by emailing firstname.lastname@example.org.
Molecular Designs: Molecular Designs develops and produces assays for molecular testing with the goal of making PCR testing widely available. We simplify the process for reference and physician office labs to expand their offering to include PCR. Learn more at MolecularDesigns.com.
Assurance Scientific Laboratories: Assurance Scientific is a highly complex CLIA certified reference lab in Birmingham, Alabama which provides infectious disease testing and toxicology for consumers, employers, clinicians, hospitals, nursing homes and other reference throughout the United States. Learn more at assurancescientificlabs.com.
Source: Molecular Designs