Visby Medical

Visby Medical

Instrument-free PCR for rapid infectious diagnostics

Overview

Visby Medical makes portable, single-use PCR diagnostic kits for infectious diseases, enabling rapid testing at the point of care or at home. Its core product is a handheld, instrument-free PCR platform that delivers lab-accurate results in under 30 minutes, with tests sold as single-use kits and, in some cases, integrated with telemedicine for at-home use. The company differentiates itself by providing true instrument-free PCR with fast turnaround and regulatory clearances (FDA-cleared and CLIA-waived) for a range of respiratory and STI tests, targeting both clinics and home settings. Its goal is to bring fast, accurate molecular diagnostics directly to patients wherever they are, enabling same-visit care and reducing reliance on centralized labs.

About Visby Medical

Simplify's Rating
Why Visby Medical is rated
B-
Rated B on Competitive Edge
Rated B on Growth Potential
Rated C on Differentiation

Industries

Biotechnology

Healthcare

Company Size

51-200

Company Stage

Late Stage VC

Total Funding

$339.5M

Headquarters

San Jose, California

Founded

2012

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Simplify's Take

What believers are saying

  • Catalio led Visby's $55 million financing in June 2025, extending launch runway.
  • FDA clearance for the multiviral at-home Flu and COVID-19 Test broadens the product pipeline.
  • Questhealth.com and Labcorp OnDemand expanded national access in January 2026, accelerating distribution.

What critics are saying

  • Quest and Labcorp control consumer demand; Visby loses pricing power and customer ownership.
  • At-home PCR diagnostics require flawless manufacturing, app performance, and telehealth coordination; failures damage trust immediately.
  • The consumer market remains unproven beyond STI and flu-COVID tests; commercialization stumbles threaten survival.

What makes Visby Medical unique

  • Visby's at-home PCR platform delivered FDA-cleared flu-COVID results in 30 minutes, July 2026.
  • Quest, Labcorp, Wisp, Everlywell, and RAINN now distribute Visby's at-home STI test.
  • Visby's instrument-free single-use PCR device compresses sampling, analysis, and treatment into one visit.

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Funding

Total Funding

$339.5M

Above

Industry Average

Funded Over

10 Rounds

Late VC funding comparison data is currently unavailable. We're working to provide this information soon!
Late VC Funding Comparison
Coming Soon

Benefits

Health Insurance

Health Savings Account/Flexible Spending Account

401(k) Company Match

Unlimited Paid Time Off

Paid Holidays

Growth & Insights and Company News

Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
Business Wire
Jul 2nd, 2026
Visby Medical receives FDA clearance for first at-home PCR test for multiple respiratory viruses

Visby Medical has received FDA clearance for the first at-home PCR test that detects multiple respiratory viruses, marking the company's second over-the-counter PCR product. The Visby Medical Flu and COVID-19 Test simultaneously screens for COVID-19 and influenza A/B, delivering results in 30 minutes. Unlike antigen tests, PCR testing can detect infections earlier and at lower viral levels, which is crucial for timely antiviral treatment. The test enables consumers to make faster decisions about care, including whether to seek medications like Paxlovid or Tamiflu, which are most effective when administered early. The test will be eligible for FSA and HSA reimbursement. Visby Medical, founded in 2012, has expanded its at-home testing platform nationwide through partnerships with DoorDash, Labcorp, Quest Diagnostics and others.

Business Wire
May 12th, 2026
Visby Medical and RAINN launch free at-home STI testing programme for sexual assault survivors

Visby Medical and RAINN have launched the Safe Access Program, providing sexual assault survivors with private, at-home STI testing. The initiative addresses barriers faced by survivors seeking testing, including privacy concerns and clinical discomfort. Visby's at-home PCR test delivers lab-quality results for chlamydia, gonorrhea and trichomoniasis in 30 minutes with over 98% accuracy. Women testing positive can access complimentary telehealth consultations and prescriptions through a third-party provider. The programme will initially distribute 1,000 test kits across 20 RAINN partner organisations nationwide, prioritising rural and underserved communities. Visby Medical aims to expand the initiative beyond this initial phase, with organisations and advocates able to support programme growth through visby.com/SafeAccess.

Associated Press
Apr 16th, 2026
Wisp partners with Visby Medical to offer FDA-authorized at-home PCR STI test with telehealth follow-up care

Wisp, the largest pure-play women's telehealth company in the US, has partnered with Visby Medical to expand access to the first FDA-authorised at-home PCR STI test. Wisp will provide follow-up telehealth care for patients who test positive for chlamydia, gonorrhea or trichomoniasis. Visby's palm-sized test delivers lab-quality results in 30 minutes via a mobile app. Patients who test positive receive a complimentary virtual consultation with a Wisp provider and, when appropriate, immediate antibiotic prescriptions. The programme initially launches through targeted patient outreach, with plans to expand nationwide. Wisp serves 1.8 million patients across the US. The test is eligible for FSA and HSA accounts. Nearly 100,000 American women lose fertility annually due to untreated STIs.

GenomeWeb
Feb 5th, 2026
Visby Medical, Watchmaker Genomics Partner to Develop At-Home Respiratory Pathogen Detection Tests

Visby Medical, Watchmaker Genomics partner to develop at-home respiratory pathogen detection tests. NEW YORK - Visby Medical said on Thursday that it has inked a partnership with Watchmaker Genomics to develop diagnostic tests for detecting respiratory pathogens in the at-home setting. To read the full story...

Home Health Provider
Nov 12th, 2025
Visby Medical Tackles STI Epidemic With First At-Home FDA-Authorized PCR Test In Partnership With Google Cloud

Visby Medical tackles STI epidemic with first at-home fda-authorized PCR test in partnership with Google Cloud. San Jose, CA (BUSINESS WIRE) - Visby Medical today announced the national launch of the first-of-its-kind FDA-authorized at-home PCR test for sexually transmitted infections (STIs) in women, redefining how sexual health is diagnosed and treated. The palm-sized test, now available nationwide with seamless virtual care support and rapid home delivery, accurately detects three of the most common and often asymptomatic infections - chlamydia, gonorrhea, and trichomoniasis - in just 30 minutes. This news comes on the heels of Visby having a long standing history of addressing healthcare epidemics in the U.S., first in 2020 with COVID-19 and now with STIs as rates continue to rise across the country. Millions of Americans still face significant barriers to convenient testing and treatment, including costs, time constraints, and concerns about privacy. According to the Office on Women's Health, 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. Left untreated, common STIs can lead to chronic pelvic pain, infertility, and life-threatening ectopic pregnancies. Visby is addressing these barriers by providing accessible, discreet, and rapid at-home care. "Today marks a paradigm shift," said Dr. Gary Schoolnik, chief medical officer at Visby Medical, Professor of Medicine at Stanford University, and former chief of Stanford Hospital's Division of Infectious Diseases who worked closely with the White House during the COVID-19 pandemic. "We've created a device empowering women to take immediate control of their sexual health - privately, accurately, and on their own terms. By compressing the time from suspicion to treatment, we're closing critical gaps in women's healthcare." Connectivity that Empowers At-Home Care Google Cloud is supporting Visby's vision to transform healthcare access, providing the secure, scalable, and AI-ready infrastructure for its digital platform. This partnership ensures users can seamlessly transition from receiving test results to accessing medical care through Optum Now, and positions Visby's platform to integrate future AI-driven healthcare solutions. With this support, Visby's app now offers an end-to-end consumer experience - from at-home PCR testing to digital results and medical guidance - with the highest levels of privacy and trust. "At Google Cloud, we're committed to using technology to make healthcare more accessible, intuitive, and human-centered," said Aashima Gupta, global director of Healthcare Strategy & Solutions, Google Cloud. "By combining Visby's breakthrough diagnostic technology with Google Cloud's AI technologies we're helping Visby deliver accurate results and actionable next steps in the moments that matter most. This is what the future of personal health should look like - private, real-time, and right at your fingertips." Instant Delivery through Leading Last-Mile Platforms To enhance accessibility, convenience, and discretion, the product is available for on-demand delivery via instant-commerce leader Gopuff, which powers deliveries placed on Visby.com straight to customers' doors, and leading local commerce platform DoorDash. This enables discrete, immediate home delivery in ten major metropolitan areas - including the San Francisco Bay Area, Las Vegas, and New York - with ongoing expansion planned for additional regions in the near future. Expanded Reach through Leading Digital Health Platforms Visby's omni-channel distribution spans leading e-commerce and digital health platforms, bringing the palm-sized sexual health test to consumers nationwide. Available now on Everlywell.com, the test expands private, self-directed access to millions of consumers through Everlywell's established diagnostics platform. "STI testing still carries significant barriers - stigma, access, and time," said Julia Cheek, Founder and CEO of Everlywell. "We're breaking those down by launching Visby's revolutionary device on Everlywell.com, empowering individuals to easily and confidently manage their sexual health at home." Looking Ahead: AI-Enabled Care & Product Roadmap Visby will continue to build on Google Cloud's Vertex AI platform with Gemini-based functionality, creating next-generation care experiences. Over the next year, AI-driven guidance will be seamlessly integrated into the user interface, providing personalized patient education and wellness advice. This could include proactive tips for sexual health, reminders for follow-up testing, and other general wellness information tailored to each user's profile. In addition, Visby Medical continues to innovate 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, further emphasizing their commitment to clinical-grade care delivered directly to homes. The Visby Women's Sexual Health PCR test is available for $149.99, covering the entire testing and treatment consultation process. Users simply swab themselves, insert the sample into the device, and receive lab-quality results within 30 minutes through a mobile app developed on Google Cloud and available for download at all major mobile app stores. The test is an eligible expense for both FSA and HSA accounts. For more information on Visby's Women's Sexual Health Test, visit visby.com. About Visby Medical Founded in 2012, Visby Medical is revolutionizing infectious disease diagnosis by empowering both physicians and patients to accurately test for infections anywhere, anytime, with laboratory accuracy. The company's proprietary technology platform delivers true PCR results in under 30 minutes through the world's first instrument-free, single-use PCR tests that fit in the palm of your hand. Currently, Visby Medical offers FDA-cleared tests for sexually transmitted infections (STIs), available both in point-of-care settings and now directly to consumers at home, and respiratory infections (COVID-19 and flu), available for point-of-care settings. Visby Medical is actively expanding its platform with a wide range of future tests for the at-home and point-of-care markets. For more information, visit visby.com. Follow Visby Medical on LinkedIn.

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