Coronavirus company news summary – FDA grants EUAs to Safetest and Advanta SARS-CoV-2 assays – PMLS launches saliva-based Covid-19 test

26 August 2020 (Last Updated August 26th, 2020 10:21)

Victory Square Health has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) to market, sell and distribute its Safetest Covid-19 assay.

The test identifies the Covid-19-causing SARS-CoV-2 virus. The test shows a sensitivity of 93.5% and specificity of 98.7%.

Fluidigm Corporation has received the FDA’s emergency use authorization (EUA) for the Advanta Dx SARS-CoV-2 RT-PCR Assay.

The assay is an extraction-free saliva-based test that is capable of identifying the nucleic acid from the SARS‑CoV‑2 virus. The test does not require samples from the nasopharyngeal area. It operates on the Fluidigm Biomark HD microfluidics platform.

Premier Medical Laboratory Services (PMLS) has launched a saliva-based Covid-19 diagnostic test. With the launch of this test, the company offers results from tests using saliva, nasopharyngeal swabs, nares swabs, sputum, nasal aspirate among others.

The test provides results within 48 hours and patients can view the results using a web-based patient portal.

Dräger Medical has opened a new facility in Pennsylvania, US for the manufacture of N95 respirator masks.

The facility will commence operations next month and provide 50 jobs for the local area. It will aid in the fulfilment of the company’s contract with the US Department of Health and Human Services for additional masks amid the Covid-19 pandemic.