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November 16, 2021

Coronavirus company news summary – US health department withdraws Trump-era policy limiting review of Covid-19 lab tests

By Chris Lo

The US Department of Health and Human Services (HHS) has announced plans to withdraw a policy put in place by the previous administration that limited the authority of the US Food and Drug Administration (FDA) to review lab-developed Covid-19 tests. The policy announced in August last year determined that the FDA should not carry out premarket review, including premarket approval or 510(k) clearance and emergency use authorisation of laboratory-developed tests (LDTs), even when poor performance is reported. Prior to August 2020, laboratories had to file applications to create and use their Covid-19 tests, CNN reported.

US-based molecular diagnostic assay provider Biocept has recorded a 165% year-on-year rise in revenues to $17.5m in Q3 2021, driven by higher reverse transcription-polymerase chain reaction (RT-PCR) Covid-19 testing. For Q3 2021, RT-PCR Covid-19 tests alone generated revenue of $16.5m with over 660,000 samples tested since June last year. Testing volumes rose during the third quarter due to the emergence of the SARS-Cov-2 Delta variant, the company reported.

Cordant Health Solutions has collaborated with US-based incubator RAIN to offer Covid-19 testing for businesses, schools and other institutions. Cordant’s offering includes reverse transcription-polymerase chain reaction (RT-PCR) testing using saliva and nasal specimens collected from symptomatic and asymptomatic people at home or at a testing site and processed at the company’s Tacoma lab. The company had also introduced a low-cost RT-PCR pooled surveillance testing method for bigger groups. These two methods deliver results in 24 hours. Cordant’s over-the-counter rapid antigen and antibody tests for home or office usage provide results in 15 minutes.

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