Visby Medical Receives FDA Clearance for First At-Home PCR Test Detecting Multiple Respiratory Viruses
Visby Medical has received clearance from the U.S. Food and Drug Administration (FDA) for its Visby Medical Flu and COVID-19 Test, becoming the first company to secure regulatory clearance for an over-the-counter, at-home polymerase chain reaction (PCR) test capable of detecting multiple respiratory viruses in a single test. The milestone further strengthens the company’s position in the rapidly evolving home diagnostics market and expands consumer access to laboratory-quality molecular testing outside of traditional healthcare settings.
The newly cleared test detects COVID-19, influenza A, and influenza B from a single sample, providing consumers with highly sensitive molecular diagnostic results in approximately 30 minutes. The clearance also marks the second FDA-cleared over-the-counter PCR product in Visby Medical’s growing portfolio of home-based diagnostic solutions, reflecting the company’s continued investment in making advanced molecular testing more accessible and convenient for patients.
Expanding the Reach of Home Molecular Diagnostics
Demand for at-home diagnostic testing has grown significantly in recent years as consumers increasingly seek convenient ways to monitor their health without visiting hospitals, urgent care centers, or physician offices.
While rapid antigen tests have become widely available for respiratory infections, molecular PCR testing has remained largely confined to clinical laboratories because of its technical complexity. Visby Medical has focused on changing that model by miniaturizing PCR technology into a portable, easy-to-use platform suitable for home use.
The FDA clearance of the Flu and COVID-19 Test represents another step toward bringing laboratory-grade diagnostic capabilities directly into consumers’ homes.
With respiratory illnesses continuing to circulate seasonally, the ability to distinguish between COVID-19 and influenza infections quickly may help individuals make informed decisions regarding treatment, isolation, and medical consultation.
Detecting Multiple Respiratory Viruses in One Test
One of the defining features of the newly cleared product is its ability to detect multiple respiratory viruses simultaneously.
Instead of requiring separate diagnostic tests for COVID-19 and influenza, the Visby Medical Flu and COVID-19 Test identifies SARS-CoV-2, Influenza A, and Influenza B using a single testing process.
Respiratory illnesses often produce overlapping symptoms, including fever, cough, fatigue, sore throat, congestion, body aches, and headaches, making it difficult for individuals to determine the underlying cause based on symptoms alone.
A multiplex PCR test capable of differentiating among multiple pathogens can provide valuable information that supports timely clinical decision-making and appropriate treatment planning.
Laboratory-Quality PCR Accuracy at Home
PCR testing has long been considered the gold standard for diagnosing infectious diseases because of its high analytical sensitivity and specificity.
Unlike rapid antigen tests, which detect proteins produced by viruses, PCR testing identifies viral genetic material and is capable of detecting infections even when viral levels remain relatively low.
This greater sensitivity enables PCR tests to identify infections earlier in the disease process, often before antigen tests become positive.
By bringing PCR technology into an over-the-counter home testing format, Visby Medical seeks to combine laboratory-quality diagnostic performance with the convenience of consumer self-testing.
According to the company, users can obtain results within approximately 30 minutes without requiring specialized laboratory equipment or technical expertise.
Supporting Earlier Treatment Decisions
Rapid and accurate diagnosis plays an important role in the treatment of respiratory infections.
Several antiviral therapies available for COVID-19 and influenza are most effective when initiated early after symptom onset.
For example, antiviral medications for COVID-19 are generally recommended within the first few days of illness for eligible patients at increased risk of severe disease.
Similarly, antiviral treatment for influenza is most beneficial when started within the first 48 hours after symptoms begin.
Earlier identification of infection allows patients to contact healthcare providers promptly, discuss treatment options, obtain prescriptions when appropriate, and reduce the risk of disease progression.
The availability of highly sensitive at-home PCR testing may therefore help shorten the time between symptom onset and treatment initiation.
Helping Consumers Make Informed Healthcare Decisions
The Visby Medical Flu and COVID-19 Test is designed to empower consumers with timely health information that supports informed decision-making.
After completing the test at home, individuals receive results identifying whether they have COVID-19, Influenza A, Influenza B, or no detectable infection among the targeted viruses.
These results may help determine whether to remain at home, seek additional medical evaluation, consult a telehealth provider, pursue antiviral treatment, or take other preventive measures to reduce transmission to family members, coworkers, or vulnerable individuals.
As telemedicine continues expanding, rapid access to reliable diagnostic information also supports virtual clinical consultations by providing healthcare providers with actionable laboratory-quality test results during remote appointments.
Company Leadership Highlights Innovation
Adam de la Zerda, founder of Visby Medical, described the FDA clearance as another important milestone in the company’s effort to expand access to molecular diagnostics.
He noted that just over a year after authorization of Visby’s first at-home PCR test, the company has successfully extended its PCR platform to include testing for some of the most common respiratory infections affecting millions of individuals annually.
According to de la Zerda, consumers can now perform PCR-quality testing at home, receive results within approximately half an hour, and use that information to make faster, more informed decisions regarding treatment and healthcare.
The company believes this capability significantly improves the accessibility of advanced diagnostic technology for everyday consumers.
Clinical Importance of Highly Sensitive Testing
Visby Medical Chief Medical Officer Dr. Gary Schoolnik emphasized the clinical significance of providing broader consumer access to highly sensitive molecular diagnostics.
He explained that more sensitive testing increases the likelihood of identifying infections during the period when antiviral therapies offer the greatest benefit.
Improved diagnostic accuracy may therefore help more patients receive timely treatment while reducing complications associated with respiratory illnesses.
Schoolnik also noted that earlier diagnosis can support improved public health by enabling infected individuals to take appropriate precautions that reduce transmission within households, workplaces, schools, and communities.
As respiratory viruses continue circulating globally, access to reliable home diagnostics remains an increasingly valuable component of healthcare delivery.
Building on an Expanding Diagnostic Portfolio
The newly cleared respiratory virus test builds upon Visby Medical’s previously authorized home PCR platform.
Rather than representing a completely new technology, the Flu and COVID-19 Test extends the company’s existing molecular diagnostic capabilities to additional infectious diseases.
Visby continues investing in the expansion of its over-the-counter testing portfolio as demand grows for convenient, rapid, laboratory-quality diagnostics that consumers can perform independently.
The company’s strategy focuses on making sophisticated molecular testing available beyond hospitals and clinical laboratories, allowing individuals to access diagnostic information whenever and wherever it is needed.
Financial Accessibility Through Healthcare Accounts
The Visby Medical Flu and COVID-19 Test will be eligible for reimbursement through Flexible Spending Accounts (FSA) and Health Savings Accounts (HSA), consistent with the company’s existing over-the-counter diagnostic products.
Eligibility for reimbursement through these healthcare spending programs may improve affordability by allowing consumers to purchase tests using pre-tax healthcare funds.
Reducing financial barriers can encourage broader adoption of advanced home diagnostics, particularly during respiratory virus seasons when multiple household members may require testing.
Expanding Distribution Across the United States
Over the past year, Visby Medical has significantly expanded nationwide access to its home testing platform through partnerships with several major healthcare and consumer service organizations.
Its previously launched at-home sexually transmitted infection (STI) testing platform is now available across the United States through partners including DoorDash, Labcorp, Quest Diagnostics, Wisp, Everlywell, and RAINN.
These collaborations demonstrate the company’s strategy of integrating home diagnostics into multiple healthcare delivery channels, including retail, telehealth, direct-to-consumer services, laboratory networks, and digital healthcare platforms.
The same approach may support broad availability of the newly cleared respiratory virus test following commercialization.
Federal Support for Diagnostic Innovation
Development of the Visby Medical Flu and COVID-19 Test received financial support from the U.S. government.
The project was funded, in whole or in part, by the Department of Health and Human Services (HHS) through the Administration for Strategic Preparedness and Response (ASPR) and the Biomedical Advanced Research and Development Authority (BARDA) under a federal contract.
BARDA has played a major role in supporting the development of innovative diagnostic technologies designed to strengthen national preparedness for infectious disease outbreaks and public health emergencies.
Government investment has accelerated the development of advanced testing platforms capable of improving access to rapid, reliable diagnostics during both routine respiratory virus seasons and future public health crises.
The FDA clearance of the Visby Medical Flu and COVID-19 Test represents a significant advancement in consumer diagnostics by introducing the first over-the-counter, at-home PCR test capable of detecting multiple respiratory viruses from a single sample. By combining laboratory-quality molecular accuracy with the convenience of home testing and delivering results in approximately 30 minutes, the product addresses a growing need for accessible, highly sensitive respiratory diagnostics.
As healthcare increasingly shifts toward decentralized and patient-centered care, technologies that enable individuals to perform sophisticated diagnostic testing at home are expected to play an expanding role in disease detection, treatment decisions, and public health. With a growing portfolio of FDA-cleared molecular diagnostics, expanding nationwide distribution partnerships, and continued investment in innovation, Visby Medical is positioning itself at the forefront of the rapidly evolving home diagnostics market while helping consumers make faster, more informed healthcare decisions.
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