Access Bio gets FDA emergency authorization for quick Covid-19 test

The company said the CareStart Covid-19 MDx RT-PCR test is designed to detect RNA from the SARS-CoV-2 virus and produce results within 83 minutes.

The Food and Drug Administration has given an emergency use authorization to a company that said its test for Covid-19 can detect infection in less than two hours.

Somerset, New Jersey-based Access Bio said Thursday that it had received the EUA for the CareStart Covid-19 MDx RT-PCR test, which is designed to detect RNA from the SARS-CoV-2 virus in 83 minutes, with 100% sensitivity and specificity. The company said it has confirmed 100% consistency in Covid-19-positive and negative groups during clinical evaluations of samples collected via nasopharyngeal swabs. Analyses can be run on common PCR processing systems, such as those from Bio-Rad and Thermo Fisher, the company said.

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“The novel coronavirus is showing no sign of slowing in the United States or other parts of the world, making the ability to quickly scale testing and diagnosis a priority,” Access Bio CEO Young Choi said in a statement. “Our products are manufactured wholly in the United States and are used by the world’s largest global health and humanitarian response organizations. We’ve worked to ensure the CareStart’s accuracy and reliability will make it a leading diagnostic testing solution in a market plagued by false methodologies and subpar alternatives.”

Other rapid tests have run into some problems, notably Abbott’s ID Now, which promised to enable point-of-care testing for Covid-19, but has since raised questions about accuracy. Meanwhile, many people in the U.S. must wait for several days to receive test results.

In an emailed statement, the company noted that ID Now and Access Bio’s testing systems use different technologies. CareStart uses real-time reverse transcription polymerase chain reaction, or RT-PCR – which most Covid-19 tests on the market also use – with a focus on two gene regions of the virus. ID Now, meanwhile, uses isothermal nucleic acid amplification technology and focuses on only one gene region. Moreover, CareStart is designed to be performed by lab technicians and is sensitive over a long time window during the period of infection, while Abbott’s is designed for point-of-care testing and is only accurate for a short window of time, within the first seven days of symptom onset.

Photo: Centers for Disease Control and Prevention