Relay Medical has signed a binding letter of intent (LOI) with Proprietary Innovation Labs (PIL) for the exclusive sale and distribution of Covid-19 rapid antigen and antibody diagnostic tests.

As per terms of the LOI agreement, Relay Medical’s diagnostics subsidiary HemoPalm will purchase the exclusive global rights of PIL’s Covid-19 product line including CE approved antibody and antigen lateral flow rapid diagnostic tests (RDT).

The deal does not cover the sale and distribution rights for China.

PIL president Richard Waters said: “The partnership between Relay and PIL is as exciting as it is important. We are now able to offer a complete holistic solution using our antigen and antibody tests in tandem with Relay’s cloud-based verification, tracking, and reporting technology.”

PIL’s test kits suitable for point of care testing

With the support of its manufacturing partners, PIL has developed both antigen and antibody tests for the SARS-CoV-2 virus.

Suitable for point of care testing, the test kits are based on lateral flow chromatographic immunoassay for qualitative detection. The tests can deliver results within 10 minutes.

PIL has a production capacity of more than 25 million tests per month through its contract manufacturing facilities.

According to PIL, the clinical sensitivity for the antigen tests is 95.0% and the clinical specificity is 99.6%.

PIL’s antigen and antibody detection kits already secured CE mark approval, enabling to market the products within the 22 countries in the European Economic Area.

PIL and Relay are also planning to submit applications to secure emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) and approval from the Health Canada under the Medical Devices Interim Order (IO).

Relay Medical CEO Yoav Raiter said: “Screening, testing and tracing is absolutely crucial to the effective management of day-to-day life during a global pandemic like Covid-19.

“This is a global infection, and management will require a plethora of solutions, technologies and protocols to allow people to return back to school, work and recreation with confidence.”

In August, Relay Medical and Fio announced the commencement of operations of the Fionet Rapid Response Group (FRR) to bring a new Covid-19 mobile testing and tracking platform to market.