Visby Medical

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.

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

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

• At-home PCR diagnostics
• Infectious disease testing
• Sexually transmitted infection tests
• Portable molecular diagnostics
• Rapid diagnostic devices

Headquarters

HQ city

San Jose

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Supply Chain, Personnel, Marketing or Sales, Operations

Revenue model

1. 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

Go-to-market motion2 records

Distribution channels6 records

Marketing channels7 records

Core 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

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Seven partnerships are on record, tiered minor, core and strategic.

• RAINNminorGTM or Marketing Partner · 15 May 2026Visby Medical partnered with RAINN on a safe access program as part of broader health tech initiatives to improve sexual health care access.
• WispcoreChannel Partner/ Reseller/ Distributor · 16 April 2026Wisp, 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 GenomicsstrategicTechnology or Integration · 5 February 2026Strategic 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 HealthminorChannel Partner/ Reseller/ Distributor · 9 January 2026Ovia 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 DiagnosticscoreChannel Partner/ Reseller/ Distributor · 8 January 2026Quest 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.
• LabcorpcoreChannel Partner/ Reseller/ Distributor · 8 January 2026Labcorp 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 CloudstrategicTechnology or Integration · 12 November 2025Visby 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

Direct 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

• Instagraminstagram.com/visbymedical
• Xx.com/visbymedical
• Facebookfacebook.com/100063593671786
• LinkedInlinkedin.com/company/visbymedical

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds12 records

Investors19 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Visby Medical