News

Visby Medical secures up to $65 million in funding led by Catalio Capital Management to accelerate the commercial launch of their FDA-authorized at-home STI test for women. The revolutionary PCR diagnostic delivers lab-accurate results in 30 minutes via smartphone app and will be available starting July 2025.

Visby Medical has submitted its Men’s Sexual Health Test to the FDA for clearance and CLIA waiver, which would provide PCR results for Chlamydia and Gonorrhea detection from male urine samples in under 30 minutes if cleared. The single-use, instrument-free point-of-care test requires no capital investment or maintenance and can be easily integrated into diverse clinical settings including urgent care centers and physician offices. This submission expands Visby Medical’s sexual health diagnostic portfolio and helps address the critical need for streamlined STI testing.

Visby Medical™ secured FDA De Novo authorization for the first OTC PCR sexual health test for women, marking a significant market entry into at-home diagnostics. The innovative, palm-sized device enables rapid, reliable testing for three common sexually transmitted infections, addressing a substantial unmet medical need. With plans for strategic partnerships and expansion into additional diagnostic markets, the company positions itself to capitalize on the growing demand for convenient, private healthcare solutions.

The Visby Medical platform offers true PCR technology; PCR is the gold standard for testing Flu A, Flu B, and COVID-19. The Visby Medical Respiratory Health Test, which fits in the palm of your hand, provides accurate results in under 30 minutes at the point of care, enabling clinicians to accurately diagnose and treat patients even in remote care facilities and other resource-limited healthcare settings where centralized laboratory services are less accessible.

Point-of-Care test significantly shortens time from ED arrival to test results, treatment and discharge – significant improvements are seen in the use of antibiotics for the treatment of chlamydia and gonococcal infections in women. Nationwide increases in sexually transmitted diseases and antibiotic resistance create the need for a paradigm shift from traditional lab-based molecular testing.

Point-of-Care test significantly shortens time from ED arrival to test results, treatment and discharge – significant improvements are seen in the use of antibiotics for the treatment of chlamydia and gonococcal infections in women. Nationwide increases in sexually transmitted diseases and antibiotic resistance create the need for a paradigm shift from traditional lab-based molecular testing.

The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) announced today that it will award biotechnology company Visby Medical of San Jose, California, up to $1.8 million to develop a portable polymerase chain reaction (PCR) test that can detect gonorrhea and assess its susceptibility to ciprofloxacin.

Visby Medical™ announced today that it has received 510(k) clearance and was granted a CLIA waiver from the FDA for its 2nd generation point of care (POC) test.

Visby Medical announced today that it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration for its Respiratory Health point of care test.

Visby Medical extends Series E round to include an additional $35 million, totaling more than $135 million raised.

Visby Medical’s CEO reaffirms support for women’s healthcare access, announcing travel expense reimbursement for employees for out-of-state pregnancy-related care.

AACC selects Visby Medical as a finalist for the 2022 Disruptive Technology Award for its handheld point-of-care PCR diagnostic technology.

Visby Medical today announced Everett Cunningham has been appointed to the company’s Board of Directors.

The Body Agency Collective, Visby Medical, Inc. and CCHCI observe National STD Awareness Month with women’s health initiative on US-Mexico border.

CCHCI among first healthcare providers in the nation to adopt new handheld PCR technology to detect gonorrhea, chlamydia and trichomoniasis in a single visit.

Pediatric urgent care provider among first in the US to adopt new point-of-care STI diagnostic device in adolescents and young adults

Visby Medical today announced that it has received an additional $25.5M in federal funding to develop and validate an at-home combination Flu-Covid test from the Biomedical Advanced Research and Development Authority (BARDA)

Investment will accelerate the development of revolutionary rapid, single-use PCR diagnostic technology for home use

Visby Medical™ announced that it will make its debut appearance at the 40th Annual J.P. Morgan Healthcare Conference.

Visby Medical™ today announced Terri S. Bresenham and Scott Edward Mendel have been appointed to the company’s Board of Directors.

Integration of the Visby Medical sexually transmitted infections (STI) panel into clinical practice could significantly reduce over- and under-treatment of Chlamydia, Gonorrhea, and Trichomonas

Thomas Prescott, former president and chief executive officer (CEO) of Align Technology and Cardiac Pathways, will join as the company’s new chairman of the board.

Visby Medical™, a leading medical diagnostic company, today announced the appointment of John W. Kuo as the company’s new Chief Legal Officer. An experienced veteran in corporate law, Kuo brings more than 30 years of experience across multiple industries, including nearly 20 years in the healthcare industry.

The Visby Medical™ instrument-free Reverse Transcription (RT)-Polymerase Chain Reaction (PCR) COVID-19 test was granted Emergency Use Authorization (EUA) by the FDA

The Visby Medical Sexual Health Click Test is the first instrument-free PCR test for the detection of Chlamydia, Gonorrhea, and Trichomonas, with results available within 30 minutes, during the patient visit.

Expanding critical access to the only single-use, rapid PCR test, at the point of care.

Visby Medical pairs speed with the accuracy of gold-standard PCR testing in a single-use device, so doctors don’t have to fight blind.

Visby Medical, an infectious disease diagnostic company, received funding from the National Institutes of Health as part of the organization’s Rapid Acceleration of Diagnostics (RADx) program, an initiative that aims to combat SARS-CoV-2 and increase national testing capacity for COVID-19.

Seven-year-old startup emerges from stealth mode, provides adaptable and rapid testing technology to frontline lab personnel fighting the pandemic

As appeared in NIH website 8/5/20