Senzo's Amplified Lateral Flow COVID-19 test.

It’s how much of the world is responsibly operating in the “new normal” right now, as we manage the ongoing pandemic while returning to something like pre-2020 life. And one Philly-area startup is hoping its tests can be a part of that system.

Senzo, a point-of-care and self-testing diagnostics company, announced this week it received 100% accuracy ratings of its Amplified Lateral Flow (ALF) COVID-19 test in a blind study led by infectious disease and COVID-19 researcher Dr. Thushan de Silva’s team at the University of Sheffield.

The nearly 20-person team, which lists offices in Bucks County’s Newtown and London, were aiming to build an at-home rapid test that produces results as accurate as a lab-tested PCR test. CEO Jeremy Stackawitz, who joined the startup last October, said that people rely on at-home tests to go about their daily lives right now, but many at-home options don’t pick up low viral loads, which are common at the start of an infection or as symptoms are setting in.

“If you test early after an exposure, and you’re currently asymptomatic, it’s quite possible you’re infected and infectious, but you’re testing negative on at at-home rest,” Stackawitz said. “Or people who are trying to do the right thing have to go to the store, to work, and wait three days for PCR test results back.”

Senzo’s ALF antigen test shows results in 10 minutes and received 100% accuracy on 25 positive and 25 negative tests, the study found, and picked up positive test results on PCR Ct values in the range of 30 to 38 (a range indicating low viral load, often very early in infection).

“If you test positive on PCR, you’ll test positive on our test,” Stackawitz said.

There have been technologies that have come to the market with similar accuracy for at-home tests, but cost the user at least $50 a test, according to Stackawitz. When Senzo’s ALF tests hit shelves, they’ll compare to BinaxNOW’s cost around $18 to $24 a box.

The next step for the company, Stackawitz said, is getting more well-respected scientific labs to test and endorse the product as they take it through the FDA clearance process, which includes clinical trials starting later this month. The CEO is hoping the tests will hit the market later this year, as people continually rely on at-home options to mitigate risk of the virus, such as when they travel and participate in in-person events.

And the process outlines what the company sees next — a similar at-home influenza test, potentially a combined COVID-19 and flu test, and an at-home sexual health testing. Stackawitz said he anticipates adding US team members in the Philly area, as Senzo builds out its commercial operational team and adds research and development team members.

The study further validates that the Senzo ALF tests can be a viable alternative to central lab testing, Stackawitz said.

“As we leverage our ALF technology across more infectious diseases, the need for patients and healthcare providers to jump through the costly and time-consuming hoops associated with central lab testing will be systematically eliminated,” he said.