Visby and Watchmaker Unite to Bring PCR Lab Power to At-Home Testing

SAN JOSE, Calif. & BOULDER, Colo. – February 05, 2026 – In a move set to redefine the landscape of home diagnostics, Visby Medical has announced a strategic collaboration with Watchmaker Genomics. The partnership aims to develop the next generation of at-home tests for respiratory pathogens, combining Visby's first-of-its-kind instrument-free PCR technology with Watchmaker's specialized expertise in high-performance enzyme engineering.

This alliance addresses a critical challenge in modern healthcare: how to provide the public with diagnostic tools that are both highly accurate and conveniently accessible. By pairing Visby’s palm-sized, rapid PCR device with Watchmaker’s robust molecular components, the two companies are working to create a test that delivers laboratory-grade results from the comfort of a user's home, a development with profound implications for personal health management and public health strategy.

The Next Frontier in At-Home Diagnostics

For years, consumers have faced a trade-off in diagnostic testing. On one side are rapid antigen tests, which are fast and easy to use but often lack the sensitivity to catch early or low-level infections. On the other is the gold-standard Polymerase Chain Reaction (PCR) test, which is exceptionally accurate but traditionally requires large, expensive equipment, trained technicians, and a lengthy wait for results from a centralized lab.

Visby Medical has been a pioneer in collapsing this dichotomy. The company developed the world’s first instrument-free, single-use PCR test, a self-contained device that fits in the palm of the hand and can deliver results in under 30 minutes. This technology effectively miniaturizes the power of a PCR lab into a disposable format. Visby has already achieved significant milestones, securing FDA De Novo authorization for an over-the-counter (OTC) women's sexual health test—the first-ever PCR device approved for OTC home use—as well as clearances for point-of-care tests for STIs and a respiratory panel covering COVID-19 and Influenza A/B. This new collaboration to enhance at-home respiratory testing is a logical and ambitious next step in its mission to decentralize diagnostics.

Engineering the Engine for Rapid Results

While an innovative device is crucial, the accuracy of any molecular test hinges on the chemical reactions happening inside. This is where Watchmaker Genomics' contribution becomes essential. At-home testing presents unique biochemical hurdles. Clinical samples collected by users, such as saliva or nasal swabs, are unprocessed and can contain a variety of substances known as molecular inhibitors, which can interfere with the test's chemistry and lead to false negatives.

Watchmaker Genomics specializes in overcoming these exact challenges through advanced enzymology. The collaboration will leverage Watchmaker's StellarScript HT+ Reverse Transcriptase, an enzyme specifically engineered to perform under pressure. It is designed to be highly tolerant of the inhibitors commonly found in clinical samples, ensuring a strong and clear signal even when the sample quality is not perfect. Furthermore, its thermostability allows it to function efficiently at high temperatures, a property that can accelerate the PCR process without sacrificing accuracy. This custom-built molecular “engine” is the key to unlocking the full potential of Visby’s platform in the demanding at-home environment, ensuring the test is not just fast, but reliably sensitive.

A Strategic Alliance for Public Health

The timing of this partnership is particularly salient. The recent public health landscape has underscored the urgent need for rapid, reliable, and widespread testing capabilities to manage infectious disease outbreaks. The ability to quickly and accurately identify respiratory pathogens is fundamental to effective treatment, infection control, and pandemic preparedness.

“Recent increases in COVID cases involving new strains and the current flu season highlight the need for tests that are reliable and fast,” explained Gary Schoolnik, MD, Chief Medical Officer at Visby Medical. “Every patient and their healthcare professional needs test results they can have confidence in so that appropriate treatment decisions can be made quickly for optimal recovery, infection control, and the judicious use of antibiotics.”

By providing PCR-level accuracy at home, such tests can empower individuals to make informed decisions immediately, reducing community spread. For healthcare systems, it offers a powerful tool for managing patient care remotely, preserving resources, and promoting the judicious use of antibiotics by distinguishing between viral and bacterial infections.

Trey Foskett, Co-Founder and CEO of Watchmaker Genomics, emphasized the synergy of the collaboration. “This partnership underscores Watchmaker’s commitment to delivering solutions that address real issues in clinically relevant applications, and we are excited to work with Visby Medical to provide a unique and urgently needed solution that utilizes their PCR platform,” he stated. The focus on creating a robust solution highlights the shared goal of fortifying public health defenses against both seasonal illnesses and future threats.

Navigating a Competitive and Regulated Landscape

Visby and Watchmaker are entering a dynamic and increasingly competitive market. The global demand for at-home diagnostics has surged, with companies like Cue Health, Lucira Health, and Abbott already offering various rapid testing solutions. The market for home respiratory therapy and diagnostics is projected to grow substantially, reaching tens of billions of dollars within the next decade.

To succeed in this space requires not only technological superiority but also significant capital and a deft navigation of the regulatory process. Visby Medical appears well-positioned on these fronts, having raised over $486 million in funding to date, including a round that valued the company at over $1 billion. This financial backing supports the extensive clinical trials and manufacturing scale-up required for a major product launch.

Furthermore, Visby's history of successful FDA submissions—from Emergency Use Authorizations (EUAs) to 510(k) clearances and a landmark De Novo authorization—provides a proven roadmap for its new respiratory test. The collaboration is also bolstered by Watchmaker's commitment to quality, evidenced by its ISO 13485 certification for medical device components. This combination of innovative science, strong financial backing, and regulatory experience creates a formidable partnership aimed at setting a new standard for infectious disease diagnosis.