The US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for MicroGEM’s Sal6830 SARS-CoV-2 Saliva Test.

The test is claimed to be the nation’s first FDA approved saliva test for Covid-19 that uses polymerase chain reaction (PCR) directly at the point of care, providing results in 27 minutes.

MicroGEM stated that the Sal6830 SARS-CoV-2 Saliva Test was clinically evaluated during the Delta and Omicron waves of the pandemic and has proven to be robust to viral mutations.

It has been designed for multiple SARS-CoV-2 gene targets, which enables robust detection of current variants and protects against obsolescence from future variants.

The MicroGEM Sal6830 SARS-CoV-2 Saliva Test’s simple workflow and easy saliva collection also reduce the workload for healthcare workers.

MicroGEM CEO Jeff Chapman said: “The MicroGEM Sal6830 SARS-CoV-2 Saliva Test will be an essential testing tool in our ongoing efforts to get our nation’s communities and businesses back to regular operations.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

“The introduction of the MicroGEM Sal6830 Point of Care PCR System marks a historic step in our mission to democratise molecular diagnostics by moving ultra-fast, high-performance testing out of laboratories and closer to people at the point of need, thus allowing decisions to be made in real-time.”

The company stated that the small size of the new saliva test allows it to be incorporated at testing sites that include ambulatory surgical centres, Clinical Laboratory Improvement Amendments (CLIA)-waived workplace testing sites, emergency departments and mobile testing labs.

The test received authorisation to detect nucleic acid from the SARS-CoV-2 virus only, and not for any other viruses or pathogens.