NASHVILLE, Tenn.--(BUSINESS WIRE)--PathGroup, one of the largest private providers of pathology, clinical and molecular laboratory services in the United States, today announced that the company has been selected as an early access partner for the launch of Illumina’s new sequencing-based COVID-19 test, COVIDSeq™. COVIDSeq accommodates more than 3,000 test samples per run, allowing for a substantial increase in testing capacity.
Illumina, a global leader in sequencing technologies, received the first Emergency Use Authorization from the U.S. Food and Drug Administration for a sequencing-based test on June 9, 2020. COVIDSeq is being rolled out via a limited number of early access sites around the world including PathGroup’s comprehensive 140,000 square foot Nashville-area laboratory.
“The use of next-generation sequencing technology allows us to rapidly scale our diagnostic testing capabilities, which is critical as workplaces and schools continue to reopen,” said Ben W. Davis, M.D., President and Chief Executive Officer of PathGroup. “We are proud to partner with Illumina to launch this groundbreaking test.”
Sequencing is an essential tool to understanding SARS-CoV-2, the virus associated with COVID-19. The use of next-generation sequencing technology to detect COVID-19 also allows researchers to sequence the full virus, increasing the amount of data available to track the movement of the virus through populations and identify changes to its makeup.
“This is an exciting step forward in helping our customers and the science community in the fight against COVID-19,” said Mark Van Oene, Senior Vice President and Chief Commercial Officer for Illumina. “COVIDSeq leverages the performance of NGS to help address the global need for diagnostic testing to fight the COVID-19 pandemic.”
Nashville-based PathGroup operates in 25 states across the Southeast, Midwest and Mid-Atlantic regions and provides comprehensive COVID-19 testing services, including both molecular diagnostic and antibody testing. All of PathGroup’s testing is performed on platforms that have received FDA Emergency Use Authorization.
For additional information about PathGroup’s COVID-19 testing capabilities, please visit the company’s online Directory of Services or contact Brent Sower at 615.234.3908 or COVID19testing@pathgroup.com.
COVIDSeq has not been FDA cleared or approved. This test is authorized by FDA under an EUA for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19. COVIDSeq is only authorized for use in laboratories in the U.S., certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Founded in 1965, PathGroup is a premier provider of anatomic, clinical and molecular pathology laboratory services in the United States. Privately held and physician-centric, PathGroup works seamlessly with customers to provide superior diagnostic services. PathGroup uses the latest in proprietary and industry standard technology to deliver fast, accurate results. The company provides clients with the highest quality of services available, consistently exceeding the expectations of physicians, employees, payers, and most importantly, patients. One Lab; Total Service. For more information, visit pathgroup.com.