Roche Gets Emergency FDA Approval for Fastest COVID-19 Diagnostic Test Yet

By Ruchi Jhonsa, Ph.D.

In the current situation, where coronavirus is spreading at a rapid rate, it is crucial to speed up the diagnosis. Looking at the growing numbers, the FDA announced that it would grant emergency authorization (EAU) to any validated coronavirus detection tests, which are yet to be approved by the FDA, to be used for SARS-CoV-2 detection. Last month, a kit developed by the Center for Disease Control and Prevention (CDC) was granted EAU by FDA. But reagent quality issues and slow detection by the CDC kit has hindered rapid viral detection. Earlier this week, FDA gave emergency authorization to two diagnostic test providers; LabCorp and Quest Diagnostics to operate PCR based tests on patient samples. However, for running the test the samples need to be transported to their facilities, resulting in a turnover time of 3-4 days that defeats the purpose of rapid detection.

Roche’s New FDA Approved Test – The Fastest Yet

Roche Holding AG, a Swiss healthcare company announced today that it has been granted emergency approval from the FDA for the SARS-CoV-2 diagnostic test, which can detect the virus at a ten-fold higher speed than the existing tests. Moreover, it reduces the need to transport the samples as tests can be easily run on any of their cobas 6800/8800 systems installed across the world. The cobas SARS-CoV-2 test is a single-well dual-target RT-PCR assay that can detect both SARS-CoV2 as well as the sarbecovirus subgenus family that includes SARS-CoV-2. The test will be used for the qualitative detection of SARS-CoV-2 virus in mouth or throat swab samples from patients presenting COVID-19 clinical symptoms.

“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO of Roche Diagnostics. “Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”

Roche cobas® 6800 System. (Image Courtesy – Roche)

The highly automated cobas system is capable of yielding 96 test results in three and half hours testing a total of 4,128 patients on 8800 system and 1440 patients on 6800 system. The system also reduces manual burden as it can run up to 8 hours with minimal human interaction topping the Roche’s existing test for the coronavirus that requires significant manual interaction. There are currently, 695 of the 6800 instruments and 132 of the 8800 system already installed worldwide of which 110 have been installed in the U.S. According to Thomas Schinker, Head of Roche’s diagnostic unit, a “significant amount” of new machines have been installed in the U.S. in past few weeks.

Roche announced today that it is going to the limits of its production capacity to provide millions of tests every month to anyone in need.

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References

1. https://www.roche.com/media/releases/med-cor-2020-03-13.htm
2. https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
3. https://newsroom.questdiagnostics.com/2020-03-05-Quest-Diagnostics-to-Launch-Coronavirus-Disease-2019-COVID-19-Test?mod=article_inline
4. https://www.labcorp.com/information-labcorp-about-coronavirus-disease-2019-covid-19
5. https://www.cdc.gov/coronavirus/2019-ncov/lab/testing-laboratories.html

Author

Ruchi Jhonsa