Visby Medical Receives FDA Clearance for First At-Home Multi-Viral PCR Test for COVID-19 and Influenza
Visby Medical, a company focused on developing rapid molecular diagnostics for use at home, has announced that the U.S. Food and Drug Administration (FDA) has granted clearance for its Visby Medical Flu and COVID-19 Test. The newly cleared diagnostic is the first over-the-counter, multi-viral polymerase chain reaction (PCR) test designed for home use, allowing consumers to detect both COVID-19 and influenza A and B infections with laboratory-quality molecular technology in approximately 30 minutes.
The FDA clearance represents another significant milestone for Visby Medical as it continues expanding its portfolio of at-home molecular diagnostics. It is the company’s second over-the-counter PCR test to receive regulatory clearance and reflects its broader mission of bringing highly accurate, laboratory-grade diagnostic technology directly into consumers’ homes.
The introduction of the Flu and COVID-19 Test comes at a time when demand for convenient home-based diagnostic solutions continues to rise. Respiratory infections remain among the most common reasons for physician visits, urgent care appointments, and emergency department utilization each year. By enabling individuals to test themselves at home and receive rapid PCR results, the new product aims to support earlier diagnosis, faster treatment decisions, and improved disease management.
Meeting the Growing Need for At-Home Respiratory Testing
The COVID-19 pandemic dramatically accelerated public acceptance of at-home diagnostic testing and highlighted the importance of rapid access to reliable results outside traditional healthcare settings.
Even as the acute phase of the pandemic has subsided, respiratory illnesses such as COVID-19 and seasonal influenza continue to place substantial burdens on healthcare systems worldwide. Millions of individuals seek medical attention annually for symptoms including fever, cough, sore throat, fatigue, congestion, and body aches, many of which overlap across multiple viral infections.
Because these symptoms are often clinically indistinguishable during the early stages of illness, laboratory testing remains essential for identifying the underlying cause and determining appropriate treatment strategies.
The newly cleared Visby Medical Flu and COVID-19 Test addresses this need by allowing consumers to simultaneously test for multiple respiratory viruses from home using molecular PCR technology.
Rather than requiring separate diagnostic tests or healthcare visits, individuals can obtain comprehensive viral testing through a single over-the-counter product that delivers results within approximately half an hour.
This capability has the potential to simplify diagnostic decision-making while reducing unnecessary visits to urgent care centers or clinics.
First Multi-Viral At-Home PCR Test
According to Visby Medical, the newly cleared diagnostic is the first at-home PCR test capable of simultaneously detecting multiple respiratory viruses.
The test identifies three important viral targets:
- COVID-19 (SARS-CoV-2)
- Influenza A
- Influenza B
Providing simultaneous detection of these common respiratory pathogens offers significant clinical value because symptoms frequently overlap, making diagnosis based on symptoms alone difficult.
Patients experiencing fever, cough, sore throat, congestion, muscle aches, or fatigue often cannot determine whether their illness is caused by influenza, COVID-19, or another respiratory virus without diagnostic testing.
By identifying the specific virus responsible for infection, patients and healthcare providers can make more informed decisions regarding treatment, isolation, monitoring, and follow-up care.
The availability of molecular PCR testing in an over-the-counter home format represents an important advancement in consumer-accessible diagnostics.
Bringing Laboratory PCR Technology Into the Home
Polymerase chain reaction testing has long been considered the gold standard for diagnosing many infectious diseases.
Unlike antigen tests, which detect viral proteins, PCR tests identify the genetic material of viruses through molecular amplification techniques that significantly increase analytical sensitivity.
Because PCR technology amplifies viral RNA or DNA, it can detect infections even when viral concentrations remain relatively low during the earliest stages of disease.
This enhanced sensitivity improves the likelihood of identifying infections before viral levels become high enough for detection by less sensitive diagnostic methods.
Historically, PCR testing required specialized laboratory equipment, trained personnel, and centralized testing facilities, often resulting in turnaround times ranging from several hours to multiple days.
Visby Medical has developed a compact testing platform that miniaturizes PCR technology into a user-friendly device suitable for home use while maintaining the high analytical performance associated with laboratory molecular diagnostics.
The result is laboratory-quality testing delivered directly to consumers without requiring specimen shipment or laboratory processing.
Faster Results May Improve Treatment Decisions
One of the primary benefits of rapid molecular testing is its ability to support timely medical decision-making.
Many antiviral medications used to treat respiratory viral infections are most effective when initiated early after symptom onset.
For example, COVID-19 antiviral therapy with Paxlovid is generally recommended during the early phase of infection for eligible high-risk patients.
Similarly, influenza antiviral medications such as Tamiflu demonstrate the greatest clinical benefit when treatment begins within the first 48 hours following symptom onset.
Delayed diagnosis may reduce opportunities for effective antiviral intervention.
By enabling individuals to receive accurate PCR results in approximately 30 minutes from home, the Visby Medical Flu and COVID-19 Test may help patients recognize infection earlier and seek appropriate medical evaluation before recommended treatment windows close.
Rapid diagnosis may also facilitate earlier telehealth consultations, prescription decisions, and implementation of infection control measures.
Founder Highlights Expansion of PCR Testing
Adam de la Zerda, founder of Visby Medical, described the FDA clearance as an important step in expanding consumer access to highly accurate molecular diagnostics.
He noted that slightly more than one year after the authorization of the company’s first at-home PCR test, Visby has successfully extended the same molecular technology platform to address two of the most common respiratory illnesses affecting millions of people each year.
According to de la Zerda, consumers can now perform PCR-quality testing from home and receive laboratory-grade results within approximately 30 minutes without needing to visit a healthcare facility.
He emphasized that rapid access to reliable molecular results enables individuals to make faster, more informed decisions regarding treatment, isolation, and medical care.
The company’s broader vision focuses on making advanced molecular diagnostics more accessible through easy-to-use consumer products that eliminate many of the traditional barriers associated with laboratory testing.
Greater Sensitivity Than Antigen Tests
A distinguishing characteristic of PCR testing is its superior analytical sensitivity compared with antigen-based diagnostics.
Antigen tests remain widely used because they are inexpensive, simple to perform, and provide rapid results. However, they generally require higher viral concentrations before producing positive results.
PCR tests can often identify infections earlier during the disease course because they detect viral genetic material even when viral loads remain relatively low.
Earlier detection offers several potential advantages.
Patients may begin appropriate treatment sooner, reduce opportunities for transmitting infection to others, and obtain greater clarity regarding the cause of respiratory symptoms before significant disease progression occurs.
Improved diagnostic sensitivity may be particularly valuable for individuals at elevated risk of severe illness, including older adults, immunocompromised patients, and those with chronic medical conditions.
Chief Medical Officer Discusses Clinical Impact
Gary Schoolnik, Chief Medical Officer of Visby Medical, emphasized the clinical significance of expanding access to highly sensitive molecular diagnostics outside traditional healthcare environments.
According to Schoolnik, broader availability of PCR-quality testing can improve opportunities for patients to receive timely treatment during the period when antiviral medications provide their greatest therapeutic benefit.
He noted that increasing access to more sensitive diagnostic technologies may ultimately contribute to improved outcomes for respiratory infections such as COVID-19 and influenza by facilitating earlier diagnosis and intervention.
Schoolnik also highlighted the importance of empowering consumers with accurate information that enables more informed healthcare decisions while supporting appropriate medical management.
As molecular testing becomes increasingly available in decentralized settings, patients gain greater flexibility in managing their health while maintaining access to high-quality diagnostic information.
Expanding Over-the-Counter Diagnostics Portfolio
The newly cleared Flu and COVID-19 Test builds upon Visby Medical’s previously authorized home testing platform.
The company has steadily expanded its portfolio of over-the-counter molecular diagnostics as part of a broader strategy to increase access to laboratory-quality testing for consumers.
In addition to respiratory diagnostics, Visby has introduced molecular testing solutions addressing other important areas of public health.
Each new product further strengthens the company’s position within the rapidly growing market for consumer-based molecular diagnostics.
The expansion reflects ongoing industry trends toward decentralizing diagnostic testing by moving sophisticated laboratory technologies closer to patients.
Reimbursement Through Consumer Health Accounts
Visby Medical announced that the newly cleared 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 testing products.
Eligibility for reimbursement through these healthcare spending programs may improve affordability for many consumers by allowing eligible purchases using pre-tax healthcare funds.
As employers and health plans continue encouraging preventive healthcare and early disease detection, reimbursement options may support broader adoption of home diagnostic technologies.
Broadening Nationwide Access
Over the past year, Visby Medical has significantly expanded distribution of its at-home diagnostic platform through partnerships with numerous healthcare and consumer service organizations.
The company’s sexually transmitted infection (STI) home testing product is now available nationwide through partners including DoorDash, Labcorp, Quest Diagnostics, Wisp, Everlywell, and RAINN.
These collaborations demonstrate Visby’s strategy of making advanced molecular diagnostics accessible through multiple distribution channels, allowing consumers to obtain testing through both traditional healthcare providers and direct-to-consumer platforms.
The expanded commercial network positions the company to support future growth as additional diagnostic products enter the market.
Supported by Federal Investment
Development of the Visby Medical Flu and COVID-19 Test received financial support from the U.S. Department of Health and Human Services through the Administration for Strategic Preparedness and Response and the Biomedical Advanced Research and Development Authority (BARDA).
BARDA has played a significant role in supporting the development of innovative medical countermeasures, including diagnostics, vaccines, therapeutics, and medical technologies intended to strengthen national preparedness for public health emergencies.
Federal support has helped accelerate development of advanced diagnostic technologies capable of improving access to rapid, reliable testing during infectious disease outbreaks.
The FDA clearance of the Visby Medical Flu and COVID-19 Test marks another important advancement in the evolution of at-home molecular diagnostics. As the first over-the-counter multi-viral PCR test designed for home use, the product combines laboratory-quality molecular accuracy with the convenience of rapid testing outside traditional healthcare settings.
By enabling simultaneous detection of COVID-19, influenza A, and influenza B in approximately 30 minutes, the test provides consumers with valuable diagnostic information that can support timely treatment decisions, telehealth consultations, and appropriate medical care. The clearance also reinforces Visby Medical’s broader strategy of expanding access to sophisticated molecular diagnostics while reducing barriers to early disease detection.
As healthcare increasingly embraces decentralized diagnostic technologies, innovations such as the Visby Medical Flu and COVID-19 Test are expected to play an increasingly important role in empowering patients, supporting precision treatment decisions, and improving the management of common infectious diseases through faster, more accessible, and highly accurate testing.
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 30 minutes through the world’s first instrument-free, single-use PCR tests that fit in the palm of your hand. Visby Medical is actively expanding its platform with a wide range of future tests for the at-home and point-of-care markets.