Chembio and Lumira to Develop POC Tests in the ‘Heat’ of COVID-19 Outbreak

The collaboration comes at a time when the need for coronavirus (COVID-19) tests is at a fever-pitch in the U.S. The need prompted FDA to grant Roche Diagnostics Emergency Use Authorization within 24 hours of receiving the application.

Omar Ford

March 13, 2020

3 Min Read
Chembio and Lumira to Develop POC Tests in the ‘Heat’ of COVID-19 Outbreak

Chembio Diagnostics has enlisted LumiraDx to develop point-of-care tests for the detection of the coronavirus (COVID-19). Demand for COVID-19 diagnostics is at a fever-pitch in the US as there is a huge struggle to get the tests into the healthcare system.

Gail Page, Chembio Diagnostics’s interim president and CEO went in more detail about working with Waltham, MA-based LumiraDx during a call with investors. Page said the diagnostics developed in the collaboration would be used on both the LumiraDx and Chembio DPP platforms.

“This expands and strengthens our existing relationship with LumiraDx and further demonstrates our scientific expertise and the versatility of our DPP platform,” Page said, according to a Seeking Alpha transcript of the call. “[Through these] joint efforts we expect the new products to provide comprehensive solutions to the new demand surrounding the worldwide testing needs for COVID-19.”

Page shed more light on the details of the agreement.

“There's a lot more in this agreement that again properly incentivizes and rewards both of us for getting the test to the market in a very expeditious manner,” Page said according to a Seeking Alpha transcript of the call. “… but also, again to point out that we're all very focused taking all the intelligence of LumiraDX and all the intelligence here to make sure we have something that's commercially viable.

Effects of COVID-19 are fast-moving causing a cloud of uncertainty in society. In the past few days schools, sporting events, conferences, and even movie premieres were canceled to reduce the spread of the virus, which has claimed the lives of 5,123 people worldwide, according to data from worldometer on Friday.

From an industry standpoint, COVID-19 has prompted FDA to take drastic measures to contain the virus. FDA began detailing some of its policies to tackle COVID-19 in late January and last week the federal agency said it was suspending inspections outside of the US.

The latest move from the agency came late last week as it issued Emergency Use Authorization (EUA) to Roche Molecular Systems for the cobas SARS-COV-2 test. FDA said it issued an EUA for the test within “24 hours of receiving the application. In a release FDA said this is the “first commercially distributed diagnostic test to receive an EUA during the COVID-19 outbreak and to expedite access to this test, it did not object to Roche pre-positioning.”

“We have been encouraging test developers to come to the FDA and work with us,” Jeff Shuren, MD, J.D., director of the FDA’s Center for Devices and Radiological Health, said in a release. “Since the beginning of this outbreak, more than 60 developers have sought our assistance with the development and validation of tests they plan to bring through the Emergency Use Authorization process. Additionally, more than 30 laboratories have notified us they are testing or intend to begin testing soon under our new policy for laboratory-developed tests for this emergency.”

About the Author(s)

Omar Ford

Omar Ford is MD+DI's Editor-in-Chief. You can reach him at [email protected].


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