Visby Medical Expands Access to First FDA-Authorized At-Home PCR Test for STIs Through Quest and Labcorp Partnerships
核心洞察
Visby Medical (搜索) has partnered with Quest Diagnostics and Labcorp to expand national access to the first FDA-authorized at-home PCR test for sexually transmitted infections (搜索), delivering lab-quality results in 30 minutes.
The palm-sized device tests for chlamydia (搜索), gonorrhea (搜索), and trichomoniasis (搜索), addressing the urgent need for accessible STI testing as nearly 100,000 women lose fertility annually due to untreated infections.
The test is now available through questhealth.com and Labcorp OnDemand, complementing existing partnerships with Everlywell (搜索), DoorDash (搜索), and GoPuff (搜索) for nationwide distribution.
Visby Medical (搜索) has significantly expanded access to its groundbreaking at-home sexually transmitted infection testing technology through new partnerships with two major diagnostic companies. The company announced agreements with Quest Diagnostics and Labcorp to distribute the Visby Women's Sexual Health Test (搜索), the first FDA-authorized at-home PCR test for STIs available to consumers.
The palm-sized device delivers confidential results for chlamydia (搜索), gonorrhea (搜索), and trichomoniasis (搜索) in just 30 minutes, representing a paradigm shift in women's sexual health diagnostics. Unlike traditional at-home STI kits that require mailing samples to laboratories, Visby's test uses PCR technology to provide lab-accurate results immediately at home.
Addressing Critical Healthcare Gaps
The expansion comes amid an urgent public health need. According to the partnerships announcement, almost 100,000 women in the United States lose their fertility every year due to complications from untreated STIs. These infections are often "silent," presenting with no symptoms while causing irreversible damage to the reproductive system.
"Infectious disease management relies heavily on the speed of diagnosis, and for too long, women's health has been hindered by delays," said Dr. Gary Schoolnik, Chief Medical Officer of Visby Medical (搜索) and Professor of Medicine at Stanford University. "When a patient has to wait days for a result, we risk the infection spreading or developing into Pelvic Inflammatory Disease (搜索) (PID). The expansion of this test provides immediate, lab-quality accuracy at home, which can move patients from diagnosis to treatment in a single day, preserving their long-term health."
The Office on Women's Health reports that more than 9 million women in the U.S. are diagnosed with an STI each year, many without noticeable symptoms, increasing the risk of serious health complications including chronic pelvic pain, infertility (搜索), and life-threatening ectopic pregnancies.
Strategic Distribution Partnerships
Quest Diagnostics added the Visby test to questhealth.com in November 2025, allowing consumers to purchase the device directly and access same-day virtual care and medication through a third-party vendor. "The addition of the Visby test to the questhealth.com menu will give women greater options for illuminating a path to good health, supplementing our comprehensive STI offerings," said Dr. Mark Kruzel, Medical Director for Quest Diagnostics Consumer division.
Labcorp OnDemand, the company's digital platform for convenient testing, now offers the Visby test through its consumer portal. Additionally, Ovia Health (搜索), a leading women's health app owned by Labcorp, will offer the solution to its employer and health plan partners in early 2026.
"For many patients, privacy and convenience are essential to seeking care," said Dr. Leslie Saltzman, Medical Discipline Director for Consumer Health at Labcorp. "Collaborating with Visby allows us to offer a fully at-home option that combines accuracy, privacy, and convenience. It's another way we're meeting people where they are and helping them take control of their health on their own terms."
Technology and User Experience
The Visby Women's Sexual Health Test (搜索) utilizes the company's proprietary PCR technology platform, delivering true PCR results through what the company describes as the world's first instrument-free, single-use PCR tests. Users collect a simple vaginal swab, insert it into the device, and receive results through Visby's secure mobile app.
The test is priced at $149.99, covering the entire testing and treatment consultation process, and is eligible for both FSA and HSA accounts. The integrated "Test-to-Treat" ecosystem enables immediate access to virtual care through partnerships with telehealth providers.
Comprehensive Distribution Network
These new partnerships complement Visby's existing distribution channels established during its November 2025 national launch. The test is available through Everlywell (搜索).com and offers on-demand delivery via GoPuff (搜索) and DoorDash (搜索) in ten major metropolitan areas, including the San Francisco Bay Area, Las Vegas, and New York, with ongoing expansion planned.
The company's technology platform is supported by Google Cloud (搜索) infrastructure, providing secure, scalable support for the digital platform and positioning for future AI-driven healthcare solutions integration.
Future Product Pipeline
Visby Medical (搜索) continues to expand its diagnostic platform with upcoming products including a men's Sexual Health test, a comprehensive sore throat panel detecting strep and common viruses, and a urinary tract infection test with antibiotic resistance detection capability. The company, founded in 2012, currently offers FDA-cleared tests for STIs and respiratory infections including COVID-19 and flu for point-of-care settings.