Sekisui Diagnostics announced today an agreement with Mesa Biotech to distribute their Accula™ SARS-Cov-2 Test which received Emergency Use Authorization (EUA) on March 23, 2020.

The Accula™ SARS-CoV-2 Test performed on the Accula™ Dock or the Silaris® Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of the coronavirus SARS-CoV-2 viral RNA. The Accula™ SARS-CoV-2 Test is performed on a palm size device which uses throat and nasal swab specimens combined, from patients suspected of COVID-19 and provides results in ~30 minutes.

Due to the urgent need for COVID-19 near patient testing and the initial production ramp up period, Sekisui Diagnostics will supply the product directly to areas which have the highest need.  After this initial, critical period the test will be supplied through its established distribution partners.

“The ability to partner with Mesa Biotech to distribute the Accula™ SARS-CoV-2 Test is significant as it brings a rapid, palm size, molecular testing solution to the fight against COVID-19 which, as we know, is critical to diagnosing patients and containing the spread”, said Robert Schruender, President & CEO of Sekisui Diagnostics.   “We will be working with Mesa Biotech to increase production so we can more broadly distribute the test to point-of-care settings where it can be most effective.”

For inquiries in to product/availability please email covid-19testing@sekisui-dx.com

This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.