The test will offer rapid PCR testing in an all-in-one device. Credit: Visby Medical.

The US Biomedical Advanced Research and Development Authority (BARDA) has awarded $12.3m to Visby Medical to accelerate the development of its rapid, single-use Flu-COVID PCR Test.

The latest development will help the company advance the next-generation device to detect flu and / or Covid-19 in one hand-held rapid PCR test for point-of-need use, and later, for at-home use as an over-the-counter test.

The test will offer rapid PCR testing in an all-in-one device that fits in the palm and requires no set-up time.

It can identify between Influenza A and B and SARS-CoV-2 and offers a fast sample-to-result time in less than 30 minutes.

Visby Medical chief medical officer Dr Gary Schoolnik said: “For decades, we’ve known that delay in diagnosis can cost a patient and doctor precious treatment time.

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“We knew we had to change the order to diagnose first, before treatment. It’s not enough to have a test, the test has to be right — and it has to be right now.”

Earlier, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) to the company’s rapid RT-PCR assay for detecting SARS-CoV-2.

Visby Medical founder and CEO Adam de la Zerda said: “For too long, our medical professionals have been fighting blind without access to rapid, accurate diagnostic testing at the point-of-care, forcing physicians to treat patients before seeing the test result.

“Effective diagnosis at the point of care is the first step to both ending this pandemic and fighting the next.”

“The good news is the investments being made into medical diagnostics should have a transformative effect long-term, and we are very pleased that BARDA recognised the importance of the Visby Medical platform technology in point-of-care and at-home settings.”

The company noted that the agreement with BARDA may be extended for a total of up to $48.7m over a course of 38 months.