NEW YORK – By becoming the first diagnostics developer to achieve regulatory clearance for a fully at-home, over-the-counter molecular test detecting sexually transmitted infections, Visby Medical believes it can pave the way for a new market.
Following de novo clearance from the US Food and Drug Administration last week for its Women's Sexual Health Test, Visby said in an interview that it is actively developing a test for men as part of its further expansion in the at-home and point-of-care diagnostics space.
The newly cleared test is a single-use chlamydia, gonorrhea, and trichomoniasis PCR assay that enables symptomatic and asymptomatic adult women to test themselves from a self-collected vaginal swab sample in their homes in less than 30 minutes. A point-of-care version of the test was granted 510(k) clearance and a CLIA waiver in 2021, and a redesigned POC version was cleared and waived in 2023.
Typically considered minor and curable infections, STIs can occasionally cause more severe long-term outcomes like infertility and chronic pelvic inflammatory disease. STIs are also a common avenue for inappropriate antimicrobial prescribing, with gonorrhea infections marking a particular hazard because of growing antimicrobial resistance.
Gary Schoolnik, Visby's chief medical officer, noted in an email that STI infection is a significant public health crisis in the US that impacts approximately 20 percent of adults in their lifetimes, sometimes without any symptoms.
The Visby at-home test can now help address this "silent epidemic," Schoolnik said, by empowering women with the privacy and confidence of lab-quality diagnostic results at home without a clinical visit.
Schoolnik said the target audience for the Women's Health OTC test includes sexually active adult women and at-risk populations, which may include college students and people taking PrEP to manage HIV infection, for example.
OraSure Technologies was the first diagnostic maker to get home-use approval for an STI test in 2012. Its OraQuick HIV lateral flow immunoassay was also the first infectious disease test cleared for home use and remained the only example until the COVID-19 pandemic eight years later.
In 2019, Binx Health became the first company with a point-of-care STI test to be cleared by the FDA, inaugurating a new era.
However, OTC testing for STIs is a novel approach, both for clinicians and consumers. Visby aims to reach consumers "through digital health platforms, national provider networks, and diagnostic service organizations," Schoolnik said.
The prevalence of STIs is one market driver in this space, he added, with others including gaps in access to care and demand for discreet and easy-to-use tests.
An evaluation of Visby’s POC STI test by researchers at Johns Hopkins University previously showed the test was significantly faster than the standard-of-care test protocol, with a median time from specimen collection to results of 47 minutes compared to 25 hours for a lab-based assay.
The Visby test also reduced the time from a patient's arrival at the emergency department to discharge, while it increased the proportion of patients receiving appropriate antimicrobial treatment, as described in a poster the team presented at the Society for Academic Emergency Medicine conference in May.
Specifically, 92.7 percent and 87.1 percent of patients got appropriate treatment for chlamydia and gonorrhea infections, respectively, with the Visby test, while those proportions were 75.1 percent and 74.3 percent with the standard-of-care protocol. The Visby POC STI test clinical trial results were also published in Lancet Infectious Diseases.
Meanwhile, the OTC version of the test has been reported to correctly identify 98.8 percent of negative and 97.2 percent of positive Chlamydia trachomatis samples, 99.1 percent of negative and 100 percent of positive Neisseria gonorrhoeae samples, and 98.5 percent of negative and 97.8 percent of positive Trichomonas vaginalis samples.
Changing the STI testing landscape
As part of its strategies to bring the STI test and others to market, San Jose, California-based Visby built a new manufacturing facility. Adam de la Zerda, founder and CEO of Visby Medical, said in an interview that the new facility supports full-scale, automated production and exemplifies the firm's commitment to operational efficiency and scalability. However, pending finalization of new sales and partnership arrangements, the firm declined to comment on its potential test production volumes.
While Visby may be the first to have received FDA authorization for an at-home, OTC STI molecular test, competition is waiting in the wings. Other firms — such as Aptitude Medical, Nuclein, Scout Health, Kryptos Biotechnologies, and Cubit Diagnostics — are currently vying for the point-of-care and at-home STI testing space.
However, Visby's handheld, disposable PCR system is a novel approach to point-of-care molecular diagnostics, which have heretofore mainly relied on isothermal approaches such as loop-mediated isothermal amplification (LAMP) or required the use of small reader devices.
Formerly known as Click Diagnostics, Visby described its core technology as both instrument-free and cartridge-free. The disposable system measures approximately 5 inches by 2 inches and performs heat and chemical lysis and thermal cycling followed by probe-based colorimetric endpoint detection.
"The power of PCR technology over other non-PCR molecular methods lies in its unmatched ability to maintain extremely high sensitivity and specificity, particularly as the demand for simultaneously testing multiple infections increases," de la Zerda noted.
Marketing STI tests directly to consumers is also not completely new, as numerous firms have obtained clearance for at-home sample collection. But the combination of self-collected samples followed by user-operated home testing using PCR is a new frontier.
"Visby Medical sees at-home PCR testing as an integral part of the evolving healthcare landscape," de la Zerda said.
Visby's OTC test "addresses a vast and critical market, encompassing tens of millions of women who may be concerned about potential STI exposure, regardless of whether symptoms are present or not," he added.
To support ease of use for the at-home assay, the firm developed an app to guide users through each step of the testing process and results interpretation, while offering them access to follow-up care.
Although its tests are disposable, "sustainability is a key priority" for Visby, de la Zerda said. "Beyond just exploring recycling solutions, we are innovating toward future product generations that incorporate reusable components," he said, which may significantly reduce environmental impact and potentially also lower production costs.
"Our long-term vision pairs exceptional diagnostic performance with responsible environmental stewardship," de la Zerda said.
In addition to the STI test for men in development — which has been previously described as a urine assay — the firm sees potential for other infectious disease testing and is targeting common conditions with panels for respiratory and sore throat infections and urinary tract infections, Schoolnik said.
Visby aims to distribute tests in its point-of-care business via a hybrid commercial model that combines direct sales with distribution partnerships. "We engage health systems, digital platforms, and POC settings," de la Zerda said, adding, "Our blended approach allows us to reach diverse segments across the care continuum, from national provider networks to specialized point-of-care environments."
For the at-home business, de la Zerda said Visby has received significant interest from commercial partners "eager to help bring Visby’s innovative STI OTC test to market," and the firm is actively evaluating these potential partnerships.
Price point is purportedly of prime importance for over-the-counter diagnostics, though pricing for Visby's STI test has not yet been finalized.
A 2021 review by researchers at the US Centers for Disease Control and Prevention noted that STIs can cause overlapping symptoms such as itching, discharge, or ulcers that prompt a desire for testing, but consumers may order unnecessary tests at a considerable cost. The OTC HIV testing options, meanwhile, are priced in the range of $40, a cost the review called a "major hurdle."
De la Zerda and Schoolnik believe that accurate PCR test results at home will reduce healthcare costs and enable prompt action to help patients, which may ultimately expand the business.
For Visby's POC Respiratory Health Test, on the other hand, pricing aligns with current reimbursement frameworks for molecular respiratory diagnostics, de la Zerda said, and supports the firm's unique positioning.
"It is intended as a cost-effective, high-performance tool for use in acute and ambulatory care settings for care teams looking to replace outdated instrument-bound antigen systems," he added.
Target customers are clinicians in acute and ambulatory care settings, including urgent care centers, emergency departments, student health centers, and community clinics, de la Zerda said, noting that Visby will reach these customers through a combination of direct sales and strategic partnerships with medical distributors such as McKesson, Henry Schein, and Medline.
Visby has been supported by the US National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) program and the US Department of Health and Human Services' Biomedical Advanced Research and Development Authority (BARDA), and more recently secured funding from CARB-X to support PCR-based antimicrobial resistance testing.
Going forward, de la Zerda said the firm expects to soon share news on the financing side, as well.