This story has been corrected to note that NowDx is capable of manufacturing 2 million tests per month, not 2 million per year.
NEW YORK – Backed by a recently closed $22.5 million funding round, testing firm NowDiagnostics (NowDx) aims to push its point-of-care and over-the-counter assays to market.
Leading the Springdale, Arkansas, company's portfolio is its lateral flow immunoassay home test for syphilis, which the firm believes could help address a growing public health crisis, said NowDx CEO Rob Weigle.
Called the First to Know Syphilis test, the assay uses capillary blood samples collected via fingerprick and is intended as a screening tool for syphilis infections, which in the last two decades have risen dramatically in the US. NowDx is currently seeking US Food and Drug Administration (FDA) de novo classification for the test.
Weigle said the focus on syphilis came from NowDx's broader work in infectious disease and sexually transmitted infections. He said that while the company has more than 30 tests in development in these areas, syphilis has become its primary area of focus as the disease has recently emerged as a major public health concern.
According to a report issued this year by the US Centers for Disease Control and Prevention (CDC), US syphilis rates have soared over the last 20 years, with the number of reported cases going from 5,979 in 2000 to 133,945 in 2020, an increase of 2,140 percent. In 2022, syphilis rates rose by 17 percent year over year.
While untreated syphilis can cause severe health problems including blindness, heart disease, and neurological conditions, most cases can be treated effectively with antibiotics, especially when detected early. Of particular concern are congenital syphilis cases, in which an infection is passed from a pregnant person to their unborn child. According to a 2023 CDC report, testing and treatment could prevent nearly 90 percent of these cases.
Syphilis testing has risen along with infection rates. For instance, Laboratory Corporation of America said that between 2012 and 2022, its syphilis testing volumes more than doubled from 2.4 million tests per year to 5.5 million. The company said it expects to see volumes increase in 2024, as well.
Weigle said NowDx began observing discussion of these trends several years ago, leading it to approach the FDA about putting together a clinical study for the syphilis test it had under development. That study ultimately enrolled roughly 1,600 subjects, and the firm submitted its de novo application based on the results at the beginning of the year. While the company has not published the study results, Weigle said it performed with sensitivity and specificity in the high-90-percent range.
There are multiple FDA-cleared lab-based tests for syphilis as well as two CLIA-waived rapid tests — Syphilis Health Check from Diagnostics Direct and DPP HIV-Syphilis, a combination HIV and syphilis rapid test from Chembio Diagnostics. Weigle said, though, that NowDx believes an OTC test could further drive uptake by allowing users to test in the privacy of their homes.
"When it comes to STIs, there is a lot of stigma around having to go into a lab or a hospital and get tested for an STI," he said. "The whole idea is to put the ability to find out first into the consumer's hands so they can act on that information once they've taken the test."
While Weigle said the First to Know test has performance comparable to lab-based tests, the assay is intended as an initial screening tool. Patients receiving a positive result should follow up with their healthcare provider for confirmatory treatment, he said.
Weigle did not provide a timeline for when NowDx might receive a decision from the FDA on the test but said that it is in talks with several retailers to offer the test in the event it does receive de novo classification. The sale price will be under $30 he said, noting that for many customers this will compare favorably with their copay for a lab-based test. The company currently has the capacity to manufacture around 2 million tests per month, Weigle said.
NowDx also continues to drive commercialization of its ADEXUSDx hCG blood-based lateral flow pregnancy test, which is available as an OTC test in European countries, including Germany and Italy, and in the US as a CLIA moderate complexity test. The company received FDA 510(k) clearance for the test in 2015 and EU approval in 2018. Since then, it has sold roughly 320,000 tests, around 70 percent in the EU and 30 percent in the US, Weigle said.
Urine-based pregnancy tests are widely used in Europe, but Weigle said he believed customers for the company's blood-based OTC test were attracted by its high accuracy. He said NowDx is currently running a clinical study comparing the test's performance to urine-based tests in which it aims to show that it is able to detect pregnancy earlier.
In the US, the test has primarily been used in clinics and hospitals, which routinely test women for pregnancy when they are admitted.
Weigle said that NowDx has partnered with Labcorp to offer the ADEXUSDx hCG in certain hospitals where it runs lab operations. Labcorp also plans to provide the company's syphilis test in hospital settings following regulatory approval, he said.
In a statement, a Labcorp spokesperson said the company had collaborated with NowDx to validate its pregnancy test and hopes to offer it and other NowDx tests to its customers once they are available.
Labcorp, through its Labcorp Venture Fund, was one of the investors in NowDx's recent funding round. The round was led by DigitalDx Ventures and also included participation from Kompass Kapital Management.
Weigle is an executive in residence with DigitalDx and was also previously CEO of AeenaDx, a diagnostic firm focused on the development of saliva-based RNA tests for diseases including breast and lung cancer. AeenaDx merged with NowDx in April 2023. Weigle said that while NowDx has retained AeenaDx's intellectual property, including an RNA collection device capable of storing samples at room temperature for up to 10 days during shipping, the company is currently focused on its OTC and lateral flow testing business.
NowDx currently has over 30 employees. In recent months, it has made several new senior hires, including Jody Berry as CSO and Todd Grice as worldwide VP of sales. Both previously held the same positions at home testing firm OraSure Technologies. Former OraSure CEO Stephen Tang is chairman of NowDx's board.