Founded Year

2012

Stage

Grant - V | Alive

Total Raised

$470.23M

Valuation

$0000 

Last Raised

$3.9M | 3 mos ago

Mosaic Score
The Mosaic Score is an algorithm that measures the overall financial health and market potential of private companies.

-83 points in the past 30 days

About Visby Medical

Visby Medical develops polymerase chain reaction (PCR)-based diagnostic tests for the detection of infectious diseases. The company offers medical solutions for sexual health tests, respiratory health tests, and other infectious diseases. It was formerly known as Click Diagnostics. The company was founded in 2012 and is based in San Jose, California.

Headquarters Location

3010 North First Street

San Jose, California, 95134,

United States

833-468-4729

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Expert Collections containing Visby Medical

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Visby Medical is included in 1 Expert Collection, including Unicorns- Billion Dollar Startups.

U

Unicorns- Billion Dollar Startups

1,270 items

Visby Medical Patents

Visby Medical has filed 39 patents.

The 3 most popular patent topics include:

  • molecular biology
  • medical tests
  • biotechnology
patents chart

Application Date

Grant Date

Title

Related Topics

Status

4/28/2020

4/1/2025

Electronic health records, Health informatics, Blood tests, Medical tests, Sensors

Grant

Application Date

4/28/2020

Grant Date

4/1/2025

Title

Related Topics

Electronic health records, Health informatics, Blood tests, Medical tests, Sensors

Status

Grant

Latest Visby Medical News

Visby Medical Receives FDA De Novo Authorization for First-Ever OTC PCR Test for Women’s Sexual Health

Apr 7, 2025

Visby Medical has received De Novo authorization from the U.S. Food and Drug Administration (FDA) for its Women’s Sexual Health Test for Over the Counter (OTC) use. According to the company it is the first-ever PCR (polymerase chain reaction) diagnostic device approved by the FDA for OTC home use for any indication. The test allows women to test reliably, rapidly, and privately at home for Chlamydia, Gonorrhea, and Trichomoniasis – the three most common curable sexually transmitted infections (STIs). Unlike other home-based STI tests on the market that require mailing samples to a laboratory, Visby’s technology provides results directly to users within 30 minutes using PCR technology, widely recognized as the gold standard in diagnostic accuracy. “This approval is not just a milestone for Visby Medical but marks a transformative moment in medical diagnostics,” said Adam de la Zerda, PhD, Founder and CEO of Visby Medical. “We’ve achieved something incredible; our palm-sized, single-use PCR test is simple to use and replaces a bulky, large, expensive laboratory instrument. After 12 years of development, our device delivers rapid, reliable results directly into the hands of consumers, with unparalleled convenience and privacy. We also built a state-of-the-art, fully automated manufacturing line ready to rapidly scale production in anticipation of growing consumer demand.” The technology has undergone extensive clinical validation, with studies involving over 2,000 lay users demonstrating that the Visby Medical Women’s Sexual Health Test delivers accuracy comparable to traditional laboratory-based PCR machines. This level of accuracy enables healthcare providers to confidently prescribe treatment based on test results. The system includes an intuitive companion app that guides users through the entire testing process—from sample collection to test execution and result interpretation—while providing a seamless connection to further care options. “The clinical significance of bringing a rapid, highly accurate PCR diagnostic test into the home environment cannot be overstated,” said Gary Schoolnik, MD, Chief Medical Officer of Visby Medical. “Extensive clinical studies validate that this test empowers women to quickly understand what steps to take next, giving them the privacy, control, and confidence to seek the care they need. Importantly, many patients infected with these STIs are non-symptomatic, yet they can still suffer serious long-term health consequences. Our test directly addresses this silent epidemic by enabling detection and treatment.” You May Also Like

Visby Medical Frequently Asked Questions (FAQ)

  • When was Visby Medical founded?

    Visby Medical was founded in 2012.

  • Where is Visby Medical's headquarters?

    Visby Medical's headquarters is located at 3010 North First Street, San Jose.

  • What is Visby Medical's latest funding round?

    Visby Medical's latest funding round is Grant - V.

  • How much did Visby Medical raise?

    Visby Medical raised a total of $470.23M.

  • Who are the investors of Visby Medical?

    Investors of Visby Medical include CARB-X, Pitango Venture Capital, John Doerr, Artiman Ventures, Blue Water Life Science Advisors and 22 more.

  • Who are Visby Medical's competitors?

    Competitors of Visby Medical include Sense Biodetection and 1 more.

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Sense Biodetection operates as a molecular diagnostics company. It designs and develops proprietary molecular and device technologies. The company serves hospitals, urgent care, nursing homes, workplace and campus health, community health, and travel sectors. The company was founded in 2014 and is based in Abingdon, U.K. In February 2023, Sense Biodetection was acquired by Sherlock Biosciences. The terms of the transaction were not disclosed.

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