As concerns mount over lack of coronavirus testing in the U.S., a Fort Worth-based biotech startup has stepped up to speed the process.
Exact Diagnostics has launched a SARS CoV-2 Standard to support laboratory assay validation of coronavirus testing, the company announced.
The company, which currently operates out of the University of North Texas Health Science Center, is offering the first 200 standards (one per account) of SARS CoV-2 Standard free of charge to labs across the U.S.
The SARS CoV-2 Standard should help labs keep pace with the increasing demand for testing.
Federal regulations require clinical laboratories to establish and document their performance specifications for laboratory-developed tests to ensure accurate and precise results before human implementations take place.
Exact Diagnostics’ SARS CoV-2 Standard contains synthetic RNA transcripts that have three gene targets – E, N and S Genes of SARS-CoV-2. It also launched the SARS-CoV-2 Negative, negative for SARS-CoV-2 that has a formulated synthetic matrix and contains human genomic DNA.
The product launches will help labs validate the entire process of a molecular assay including extraction, amplification, and detection.
California-based life science giant Bio-Rad Laboratories had acquired the Fort Worth startup in August.
“In a public health emergency, it is critical that labs have access to well-defined standards to help with the validation of their tests,” Dara Wright, Bio-Rad executive vice president, said in a statement. “The SARS CoV-2 Standard helps to validate COVID-19 tests, which enables more laboratories to meet the growing demand for identification of this coronavirus.”
According to Centers for Disease Control and Prevention [CDC], 84 state and local public health laboratories in 50 states and the District of Columbia have successfully verified COVID-19 diagnostic tests and are offering testing.
After have low number of tests available in the first two months of the year, testing in U.S. labs for COVID-19 has drastically risen in the last couple of weeks.