Visby Medical
Visby Medical is a San Jose-based diagnostics company developing FDA-authorized, palm-sized PCR tests for at-home infectious disease detection. Its flagship product is the first FDA-cleared at-home PCR test for three STIs, sold direct-to-consumer and through lab and telehealth partners.
- Company typePrivate
- Founded2012
- HeadquartersSan Jose, United States
- Headcount101–250
- GTM typeB2C
- OfferingHardware or Manufacturing
What Visby Medical does
Visby Medical, Inc. is a privately held diagnostics company headquartered at 3010 North First Street in San Jose, California, founded in 2012. The company develops portable, instrument-free polymerase chain reaction (PCR) testing devices that deliver laboratory-quality results in approximately 30 minutes without requiring laboratory equipment or mailed samples. Its flagship commercial product is the Women's Sexual Health Test, authorized by the FDA in March 2025 as the first at-home PCR test for chlamydia, gonorrhea, and trichomoniasis. The underlying platform is a palm-sized, single-use nucleic acid amplification device paired with a smartphone application that delivers instructions, private results display, and integrated telehealth routing.
Visby operates a hybrid direct-to-consumer and channel-partner business model. End consumers purchase the test for approximately $149-$179 per unit, with HSA/FSA eligibility, through the company's visby.com storefront and mobile apps, as well as through distribution partners including Quest Diagnostics (questhealth.com), Labcorp OnDemand, Wisp women's telehealth, Gopuff and DoorDash last-mile delivery, Google Cloud (delivery infrastructure), and Ovia Health (employer and health plan channels). Positive results are routed to third-party licensed telehealth providers for same-day consultation and treatment when clinically appropriate.
Visby has raised approximately $435 million cumulatively across equity and grant funding, including a Series E exceeding $135 million in 2022, $25.5 million from BARDA for a Flu-COVID combination test, $5.7 million in CARB-X grants for gonorrhea antibiotic susceptibility work, and an approximately $55 million round led by Catalio Capital Management in June 2025. The company is led by founder and CEO Adam de la Zerda with a chief medical officer (Gary Schoolnik) and senior manufacturing/operations leadership, and is developing additional tests including a Flu-COVID PCR combination assay and a portable gonorrhea antibiotic susceptibility diagnostic.
Visby Medical firmographics
Firmographics- Name
- Visby Medical
- Legal name
- Visby Medical, Inc.
- Website
- https://visbymedical.com
- Company type
- Private
- Founded year
- 2012
- Operating status
- Operating
- Headcount range
- 101–250 employees
- Short description
- Visby Medical is a San Jose-based diagnostics company developing FDA-authorized, palm-sized PCR tests for at-home infectious disease detection. Its flagship product is the first FDA-cleared at-home PCR test for three STIs, sold direct-to-consumer and through lab and telehealth partners.
- Ownership category
- akta.pro rank
Visby Medical industry classification
Industry- Product category
- At-Home Molecular Diagnostics
- NAICS
- Electromedical and Electrotherapeutic Apparatus Manufacturing (334510)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Surgical & Medical Instruments & Apparatus (3841)
- akta.pro primary industry
- Home-Use & OTC Rapid Self-Tests (Consumer POCT kits) (HLAHAOAK)
- akta.pro secondary industries
- Home Diagnostic & Self-Test OTC Kits (HLAIADAO), Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK), Molecular & Genetic Testing (PCR/NGS/qPCR) (HLAGADAF), Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL)
Keywords
Where Visby Medical is headquartered
LocationHeadquarters
- HQ city
- San Jose
- HQ country
- United States
- HQ region
- North America
Offices1 record
Markets served
Visby Medical business model
Business model- GTM type
- B2C
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations
Revenue model
- At-Home Diagnostic Test Sales: Visby Medical generates revenue through direct-to-consumer sales of its FDA-authorized at-home PCR test kits. Consumers purchase the single-use test devices directly through the company's website, app, and partner platforms like Quest Diagnostics and Labcorp.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Unit Pricing | Pay-as-you-go | Single at-home PCR STI test for chlamydia, gonorrhea, and trichomoniasis |
| Unit Pricing | Pay-as-you-go | Women's Sexual Health Test via Gopuff delivery |
| Unit Pricing | Pay-as-you-go | Direct-to-consumer at-home STI test |
Go-to-market motion2 records
Distribution channels6 records
Marketing channels7 records
Visby Medical product offering
Product offeringCore offering
Visby Medical develops and sells palm-sized, single-use PCR diagnostic devices that deliver lab-quality results in approximately 30 minutes without requiring laboratory instruments or mailed samples. Its flagship commercial product is the FDA-authorized Women's Sexual Health Test, an at-home PCR test detecting chlamydia, gonorrhea, and trichomoniasis with 98% accuracy, integrated with a smartphone app and optional same-day telehealth treatment for positive results. The company is also developing a multiplex at-home Flu-COVID PCR test and a portable rapid diagnostic for gonorrhea and antibiotic susceptibility.
Product overview
Visby Medical offers a portfolio of portable, rapid PCR diagnostic tests for infectious diseases. The flagship product is the FDA-authorized Women's Sexual Health Test (At-Home STI Test), the first at-home PCR test for chlamydia, gonorrhea, and trichomoniasis delivering results in 30 minutes. The company is also developing a Flu-COVID PCR test (funded by BARDA) and a portable gonorrhea/antibiotic susceptibility test (funded by CARB-X). All products leverage the company's instrument-free PCR testing platform designed for point-of-care and at-home use.
Differentiator
Problem solved
Functional benefit
Brands
- Visby Women's Sexual Health Test: FDA-authorized at-home PCR test for chlamydia, gonorrhea, and trichomoniasis that delivers results in 30 minutes without mailing samples to a lab
Products and services
- Women's Sexual Health Test (At-Home STI Test) First FDA-authorized at-home PCR test for chlamydia, gonorrhea, and trichomoniasis. Palm-sized single-use device delivers lab-quality results in 30 minutes with 98% accuracy, integrates with a smartphone app for private result display, and includes optional same-day telehealth consultation and treatment for positive results.
- Flu-COVID PCR Test At-home rapid PCR test in development to detect influenza A, influenza B, and SARS-CoV-2, delivering results in less than 30 minutes and integrating with digital health systems for access and reporting.
- Portable Rapid Diagnostic for Gonorrhea and Antibiotic Susceptibility Portable molecular test in development for gonorrhea detection and antibiotic susceptibility testing, intended for rapid on-site use, particularly in low-resource settings, to guide appropriate treatment of drug-resistant infections.
Quantifiable outcome
- 98% Accuracy - Gold-standard PCR accuracy in the palm of your hand
- +2 more outcomes
Companies that use Visby Medical
Customer profileNamed customers3 records
Segments2 records
Ideal customer profiles2 records
Visby Medical technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature4 records
Visby Medical partnerships and signals
Strategic signalPartnerships
Seven partnerships are on record, tiered minor, core and strategic.
- RAINNminorVisby Medical partnered with RAINN on a safe access program as part of broader health tech initiatives to improve sexual health care access.
- WispcoreWisp, the largest women's telehealth provider in the U.S., partnered with Visby Medical to expand access to the first FDA-authorized at-home PCR STI test. The palm-sized test delivers results in 30 minutes, and patients who test positive receive a complimentary virtual consultation with a licensed Wisp provider and immediate access to treatment when clinically appropriate.
- Watchmaker GenomicsstrategicStrategic collaboration to develop next-generation diagnostic tests for respiratory pathogen detection in the at-home setting. The partnership combines Visby Medical's instrument-free PCR testing technology with Watchmaker's inhibitor-tolerant StellarScript HT+ Reverse Transcriptase enzyme to address molecular performance challenges in unprocessed clinical samples.
- Ovia HealthminorOvia Health plans to offer Visby Medical's at-home STI test to employer and health plan partners starting early 2026, expanding access through workplace and insurance channels.
- Quest DiagnosticscoreQuest Diagnostics added Visby Medical's FDA-authorized at-home PCR test for STIs to its direct-to-consumer offerings on questhealth.com. The partnership expands Quest's at-home diagnostics menu and aligns with growing demand for convenient, private testing options. Available since November 2025.
- LabcorpcoreLabcorp added Visby Medical's FDA-cleared at-home PCR test for sexually transmitted infections to its direct-to-consumer offerings through Labcorp OnDemand platform. The single-use test provides results within 30 minutes for chlamydia, gonorrhea, and trichomoniasis.
- Google CloudstrategicVisby Medical launched its first FDA-authorized at-home PCR test for STIs in partnership with Google Cloud, utilizing Google Cloud's AI infrastructure and delivery platforms like Gopuff and DoorDash for nationwide availability.
Scale indicators7 records
Recent moves6 records
Expansion highlights6 records
Visby Medical competitors and assessment
Company assessmentDirect peers
- Cue Health: Former direct competitor in at-home PCR diagnostics for infectious diseases. Cue Health developed a connected molecular testing platform for at-home COVID, RSV, and sexual health testing, providing the closest product and GTM analog for Visby. Note: Cue Health wound down operations in 2024–2025, illustrating both the opportunity and category-formation risk.
- binx health: Direct competitor in at-home and point-of-care STI testing, including chlamydia and gonorrhea. binx health operates both a consumer at-home collection kit (io) and a clinical molecular platform, addressing the same patient population and use cases as Visby.
- Lucira Health (Pfizer): Maker of the first FDA-authorized at-home PCR COVID test (and influenza combination test), acquired by Pfizer in 2023. Closest historical precedent for a single-use, instrument-free at-home molecular test in the US market.
Broad incumbents
- Cepheid (Danaher): Market leader in clinical molecular PCR testing (GeneXpert platform) used widely in hospitals, clinics, and reference labs. Sets the lab-quality benchmark Visby matches at home and represents the incumbent whose tests Visby aims to displace in the consumer channel.
- Abbott Diagnostics: Incumbent diagnostics giant with extensive at-home and point-of-care testing portfolios including BinaxNOW COVID/Flu and ID NOW molecular platform. Competes with Visby across both consumer and clinical segments.
- Hologic: Incumbent in women's health diagnostics with the Aptima line of molecular STI assays run on the Panther system. Direct competitor in the STI testing market Visby is targeting, particularly in clinical and lab-based settings.
- Roche Diagnostics: Global diagnostics incumbent with cobas Liat point-of-care PCR system and broad STI test menu. Represents both a competitive threat in clinical POC and a partner/distribution opportunity.
- Becton Dickinson (BD): Major diagnostics player with the BD Veritor rapid testing platform and BD MAX molecular system. Competes in both rapid antigen and molecular diagnostics segments relevant to Visby's current and pipeline products.
Emerging players
- Sherlock Biosciences: CRISPR-based molecular diagnostics company developing at-home and point-of-care infectious disease tests. Represents an emerging alternative molecular technology approach that could compete with Visby's PCR platform.
- Molecular Loop: Early-stage molecular diagnostics startup developing rapid, low-cost PCR tests for consumer and clinical use cases including STIs. An emerging competitive threat in the at-home molecular testing category.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights7 records
Customer concentration
Visby Medical social profiles
Digital presenceVisby Medical financial estimates
Financial estimateRevenue estimate
Valuation estimate
Visby Medical leadership team
Management profileNumber of profiles
Profiles5 records
Visby Medical funding detail
Funding detailFunding overview
Funding rounds12 records
Investors19 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Visby Medical M&A and investment
M&A and investmentM&A
Investments
M&A and investment is available on the Subscription and Enterprise plan.Contact sales →
Frequently asked questions about Visby Medical
What does Visby Medical do?
Visby Medical develops and sells palm-sized, single-use PCR diagnostic devices that deliver lab-quality results in approximately 30 minutes without requiring laboratory instruments or mailed samples. Its flagship commercial product is the FDA-authorized Women's Sexual Health Test, an at-home PCR test detecting chlamydia, gonorrhea, and trichomoniasis with 98% accuracy, integrated with a smartphone app and optional same-day telehealth treatment for positive results. The company is also developing a multiplex at-home Flu-COVID PCR test and a portable rapid diagnostic for gonorrhea and antibiotic susceptibility.
Is Visby Medical a public or private company?
Visby Medical is a private company. It is classified as venture growth investor backed and is currently operating.
When was Visby Medical founded?
Visby Medical was founded in 2012. It employs 101 to 250 people.
Where is Visby Medical based?
Visby Medical is headquartered in San Jose, United States, in the North America region.
How does Visby Medical make money?
One revenue line is on record: at-Home Diagnostic Test Sales.
Who are Visby Medical's main competitors?
Direct peers on record are Cue Health, binx health and Lucira Health (Pfizer). Broad incumbents are Cepheid (Danaher), Abbott Diagnostics, Hologic, Roche Diagnostics and Becton Dickinson (BD). Emerging players are Sherlock Biosciences and Molecular Loop.
Does Visby Medical have an API?
No public API is recorded for Visby Medical.
What industry is Visby Medical in?
Visby Medical's product category is At-Home Molecular Diagnostics. Its primary akta.pro industry code is HLAHAOAK, Home-Use & OTC Rapid Self-Tests (Consumer POCT kits), with a secondary code of HLAIADAO, Home Diagnostic & Self-Test OTC Kits. Its NAICS code is 334510 and its SIC code is 2835.