Longhorn Vaccines and Diagnostics, Bethesda, Md, an innovative molecular tool, assay, and vaccine development company focused on serving unmet critical needs in both developed and developing nations, has announced that FDA has recommended that the company collaborate with diagnostic assay manufacturers to ensure that Longhorn’s PrimeStore MTM is included as a transport device in emergency use authorization (EUA) applications submitted to the agency for research samples for the coronavirus disease 2019 (COVID-19). The suggestion comes in conjunction with key actions to advance development of novel Coronavirus medical countermeasures outlined by FDA’s Center for Devices and Radiological Health.
“In the wake of the COVID-19 outbreak, US diagnostic manufacturers are developing and submitting to FDA EUA applications for nucleic acid-based tests for COVID-19 using sample collection devices such as viral transport mediums that keep the virus alive within the sample requiring refrigeration and containment,” says Jeff Fischer, president of Longhorn. “Unlike standard methods for collecting and transporting samples, PrimeStore MTM safely deactivates pathogens at the point of collection and stabilizes RNA and DNA, allowing enhanced point of care and ambient temperature transport for laboratory-based molecular testing and characterization, with no need for special containment facilities.”

Currently, COVID-19 assays approved for EUA with viral transport medium must be run in biosafety level (BSL) 3 or 4 laboratories or inactivated under containment conditions. “There are simply not enough of these facilities to meet the medical and scientific community’s demands for up-to-the-minute results,” explains Fischer. “Deactivating samples will allow for testing to be conducted in many more labs, including BSL-1 and BSL-2 facilities.”

For further information, visit Longhorn Vaccines and Diagnostics.