Biosearch Technologies Gets FDA’s Emergency Use Authorization for Its COVID-19 Test

The FDA granted Biosearch Technologies an Emergency Use Authorization for its ultra-high-throughput COVID-19 diagnostic, the EndPoint reverse transcription-polymerase chain reaction (RT-PCR) test.

The test is authorized for detection of nucleic acid from the SARS-CoV-2 coronavirus in anterior nasal swab specimens that are collected from individuals either with or without symptoms or other reasons to suspect COVID-19 infection. The nasal samples must be collected by a healthcare provider or self-collected under supervision by a healthcare provider.

To use the product, dry anterior nasal swab specimens are rehydrated and the SARS-CoV-2 viral particles are inactivated. The released nucleic acid is then reverse transcribed into complementary DNA followed by PCR amplification and the use of a fluorescent detection instrument.

The samples may only be processed by laboratories that are certified to perform thigh-complexity tests, the agency said.