On Tuesday, January 26th, Governor Andy Beshear's office announced that the first two cases of a more contagious variant of coronavirus, first identified in the United Kingdom, have been confirmed in Kentucky. Local Covington-based Gravity Diagnostics began coordinating with the Kentucky Department of Health weeks ago to submit specimens with a unique detection pattern for sequence analysis. This led to the discovery announced on Tuesday by Beshear's office. Dr. Steven Stack, commissioner for public health for the Commonwealth of Kentucky, thanked the laboratory during the Governor's press conference Wednesday afternoon.

Background from Gravity Diagnostics on detection of SARS-CoV-2 emerging variants

Gravity Diagnostics utilizes a molecular test for the detection of SARS-CoV-2.  Our test relies on specific RNA sequences for the identification of the virus in clinical specimens.  However, RNA viruses, such as SARS-CoV-2, mutate resulting in changes to their RNA sequence.  One specific mutation in the S-gene is associated with an increased risk of transmission, the B.1.1.7 variant. This variant contains a deletion in the S-gene which can impact the detection of SARS-CoV-2 with molecular tests.

Impact on Gravity Diagnostics SARS-CoV-2 RT-PCR Assay (EUA202301)

Gravity Diagnostics utilizes a modification of the ThermoFisher TaqPath COVID-19 Combo Kit for our SARS-CoV-2 testing.  Their methodology detects three distinct genes (S-gene, N-gene, ORF1ab) in the SARS-CoV-2 viral genome, which offers a built-in redundancy for detection of the virus.  They have become aware that certain variants will not have the S-gene amplify, but the other two targets will detect the SARS-CoV-2 virus. Analysis by the FDA suggests no impact to the overall sensitivity of the assay.  In fact, they can use this pattern of detection to possibly track new variant spread.  Once this was known, they began to coordinate with the Kentucky Department of Public Health to submit specimens with this detection pattern for sequence analysis.  This information will be used to prepare public health officials with contact tracing and potentially prevent further spread of infection.

"I reached out to our Director of Research and Development, Ryan Walker, PhD., in late December to begin research on how we could start testing for and tracking the SARS-CoV-2 variants. At Gravity part of our core mission is always to go beyond testing samples and reporting results to being a part of a larger, more comprehensive solution that makes a positive impact on and protects our community. With the pandemic, one way we are doing that is by providing more information to the experts who are tracking and coordinating efforts in the field, not just the baseline 'positive and negative' test results. This recent assistance in the discovery of the first two variants of the U.K. strand is a testament to the dedication and expertise of our clinical team. I could not be prouder and we will continue to expand and support these efforts," said Julie Brazil, chief operating officer at Gravity Diagnostics.

About Gravity Diagnostics

Gravity Diagnostics is a full-service state-of-the-art CLIA laboratory licensed in all 50 states providing innovative laboratory testing in the areas of COVID-19, Upper Respiratory, Toxicology, Pharmacogenomics, and Sexually Transmitted Infections. We are an advocate for physicians, patients, and our communities, supporting them with unsurpassed integrity, regulatory compliance, and clinical expertise. We currently service over 750 customers from small private practices, to universities, to Fortune 500 companies.