visby.com

What visby.com does

Visby Medical, Inc. is a privately-held medical device company founded in 2012 and headquartered at 3010 North First Street, San Jose, California. The company develops palm-sized, single-use, instrument-free PCR (polymerase chain reaction) diagnostic devices designed to deliver laboratory-quality molecular results outside of traditional clinical laboratories. Its flagship product is the Visby Women's At-Home STI Test Kit, the first FDA-authorized over-the-counter at-home PCR test for chlamydia, gonorrhea, and trichomoniasis, priced at $149.99 (sale) to $179.99 (regular). A companion mobile app (iOS and Android) guides sample collection, captures and analyzes device images for result interpretation, and connects positive users to third-party licensed telehealth providers for same-day treatment.

Visby monetizes through direct-to-consumer hardware sales via visby.com and a layered channel network that includes Quest Diagnostics (questhealth.com), Labcorp OnDemand, Ovia Health, Everlywell, Wisp, and rapid-delivery partners DoorDash and GoPuff, with discreet packaging and HSA/FSA eligibility. The company received BARDA federal development support (contract 75A50121C00019) and expanded its OTC portfolio in July 2026 with FDA clearance of a multi-viral Flu and COVID-19 PCR test, the first at-home PCR panel for respiratory infections. Visby is led by founder and CEO Adam de la Zerda, PhD, with Gary Schoolnik, MD, as Chief Medical Officer, and is currently focused on scaling consumer access across the United States, with sales geographically restricted outside the US.

Name

visby.com

Legal name

Visby Medical, Inc.

Website

https://visby.com

Company type

Private

Founded year

2012

Operating status

Operating

Short description

Visby Medical develops palm-sized, single-use PCR diagnostic devices for at-home use. Its FDA-authorized Women's At-Home STI Test detects chlamydia, gonorrhea, and trichomoniasis in 30 minutes, sold direct to consumers and via Quest, Labcorp, Everlywell, DoorDash, and GoPuff.

Ownership category

akta.pro rank

Product category

At-Home Molecular Diagnostics

NAICS

Medical Equipment and Supplies Manufacturing (3391)

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

Pregnancy, Fertility & Women’s Health Rapid Tests (hCG, ovulation, vaginal infection) (HLAHAOAF), Remote Diagnostics & Point-of-Care (Connected Testing, Home Lab Devices) (HLACAPAK), Remote Diagnostics & Home Testing Devices (Connected POC/At-Home Diagnostic Readers) (HLAHACAL), Home Diagnostic & Self-Test OTC Kits (HLAIADAO), Personal Medical Devices & Home Diagnostics (Thermometers, Blood Pressure Monitors, Glucose Meters, Rapid Tests) (CRADAMAK)

Keywords

• At-home PCR testing
• Molecular diagnostics
• STI screening
• Infectious disease testing
• 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, Operations, Marketing or Sales, Personnel, Infrastructure

Revenue model

1. At-Home STI Test Kit Sales: Direct sales of single-use PCR test kits to consumers at $149.99 (sale price) or $179.99 (regular price). Product available for purchase directly through visby.com and via retail/lab partners. HSA/FSA eligible.
2. Telehealth Services (Third-party): When users test positive, they can connect with third-party licensed telehealth providers through the app for consultations and prescriptions. Additional fees apply for telehealth visits and prescribed medications per provider discretion.
3. Affiliate/Partner Revenue: Affiliate program through Impact where partners earn commission promoting Visby products. Partners include healthcare content creators, influencers, and affiliate marketers.

Pricing tiers

Go-to-market motion3 records

Distribution channels7 records

Marketing channels6 records

Core offering

Visby Medical sells FDA-authorized at-home PCR diagnostic test kits that deliver laboratory-quality results in 30 minutes without instrumentation. The flagship product is a single-use vaginal swab test that simultaneously detects Chlamydia, Gonorrhea, and Trichomoniasis in women, supported by a companion mobile app for guided sample collection, image-based result interpretation, encrypted result delivery, and connection to third-party telehealth providers for treatment. A second FDA-cleared product detects COVID-19 and Influenza A/B. Kits are sold direct-to-consumer and through healthcare and retail partners.

Product overview

Visby Medical offers a portfolio of rapid molecular diagnostic tests for home use based on proprietary PCR (polymerase chain reaction) technology. The flagship product is the Visby Women's At-Home STI Test Kit, the first FDA-authorized OTC PCR test for sexual health that detects chlamydia, gonorrhea, and trichomoniasis with results in 30 minutes. The company has expanded into respiratory diagnostics with the Visby Medical Flu and COVID-19 Test (FDA-cleared). All tests utilize a palm-sized, single-use device and require the Visby Medical companion app for guided testing, result interpretation via image analysis, and access to telehealth services.

Differentiator

Problem solved

Functional benefit

Products and services

• Visby Women's At-Home STI Test Kit The first FDA-authorized over-the-counter at-home PCR test for women's sexual health. A single vaginal swab simultaneously detects Chlamydia, Gonorrhea, and Trichomoniasis with laboratory-quality results in 30 minutes. Includes connection to third-party licensed telehealth providers at no extra cost if the user tests positive. Designed for women 14 years and older.
• Visby Medical Flu and COVID-19 Test FDA-cleared multi-viral at-home PCR test that detects COVID-19 and Influenza A/B in 30 minutes with lab-quality sensitivity. HSA and FSA eligible. Targeted at point-of-care clinical settings with planned expansion to the at-home market.
• Visby Medical App Companion mobile application for iOS and Android required to use the Visby test. Uses short, muted-by-default video instructions to guide sample collection, captures and analyzes photos of the test device via computer vision to interpret results, delivers results to a secure password-protected interface, and connects positive users to third-party licensed telehealth providers.

Quantifiable outcome

• 97.2% positive specimen detection rate for Chlamydia (103/106) and 98.8% negative (1815/1837)
• +4 more outcomes

Named customers11 records

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration2 records

AI capability2 records

Feature5 records

Partnerships

Ten partnerships are on record, tiered minor and core.

• WispminorChannel Partner/ Reseller/ Distributor · 13 July 2026Digital health platform partner offering Visby at-home STI test to consumers.
• RAINNminorChannel Partner/ Reseller/ Distributor · 13 July 2026Partnership with RAINN (Rape, Abuse & Incest National Network) to expand access to sexual health testing resources and support.
• Quest DiagnosticscoreChannel Partner/ Reseller/ Distributor · 8 January 2026Quest Diagnostics' consumer-initiated testing platform (questhealth.com) offers Visby test with same-day virtual care access through third-party vendor. Expands national retail access for at-home STI testing.
• LabcorpcoreChannel Partner/ Reseller/ Distributor · 8 January 2026Labcorp OnDemand and Ovia Health platforms now offer the Visby Rapid PCR At-Home test, expanding consumer access through Labcorp's digital testing ecosystem and women's health app integration.
• Google CloudcoreTechnology or Integration · 18 December 2025Google Cloud partnership supporting the company's new rapid women's sexual health test. National launch of first-at-home FDA-authorized PCR test for STIs with cloud infrastructure supporting the Test-to-Treat ecosystem.
• EverlywellcoreChannel Partner/ Reseller/ Distributor · 18 December 2025Direct-to-consumer partnership making Visby test available through Everlywell's at-home testing platform.
• DoorDashcoreChannel Partner/ Reseller/ Distributor · 18 December 2025DoorDash Drive partnership enabling discreet 30-60 minute delivery of Visby test kits to consumers in select cities. Part of direct-to-consumer expansion.
• GoPuffcoreChannel Partner/ Reseller/ Distributor · 18 December 2025GoPuff partnership enabling rapid delivery of Visby test kits as part of the direct-to-consumer expansion strategy.
• ImpactminorGTM or Marketing PartnerAffiliate partnership platform (Impact.com) enabling influencers and marketers to promote Visby products and earn commission on sales. Process takes 5 minutes to sign up.
• Third-party Telehealth ProviderscoreStrategic or Co-development PartnerLicensed telehealth providers integrated into the Visby app for same-day consultations and prescriptions when users test positive. Included at no extra cost for positive results. Healthcare providers can review test results and prescribe treatment.

Scale indicators6 records

Recent moves6 records

Expansion highlights7 records

Direct peers

• myLAB Box: Direct peer in at-home STI testing, with overlapping chlamydia/gonorrhea/trichomoniasis kits sold direct-to-consumer. Comparable target customer (women seeking private STI screening) and DTC e-commerce business model.
• Everlywell: Direct peer in direct-to-consumer at-home testing. Everlywell sells a broad at-home diagnostics portfolio and is simultaneously a Visby distribution partner, making it a partly-aligned competitor in the consumer-initiated testing category.
• Cue Health: Direct peer in at-home molecular diagnostics. Cue developed and commercialized an OTC molecular diagnostic platform (COVID-19 and respiratory multiplex tests) and is the most directly comparable at-home PCR/NAAT company to Visby in terms of business model and consumer channel.
• LetsGetChecked: Direct peer in direct-to-consumer at-home diagnostics with mail-in and self-collected testing. Overlaps with Visby on women's health/STI test offerings and on the integrated telehealth/Test-to-Treat consumer experience.
• Lucira Health (acquired by Pfizer): Direct peer in single-use, instrument-free at-home PCR/molecular tests. Lucira's at-home COVID and flu tests competed in the same OTC molecular category before its Pfizer acquisition, representing the closest technology and form-factor analog to Visby's palm-sized PCR.

Broad incumbents

• Cepheid (Danaher): Broad incumbent in rapid PCR via the GeneXpert platform. While primarily point-of-care clinical, Cepheid's speed-to-result and installed footprint set the bar Visby's instrument-free 30-minute PCR competes against.
• Hologic: Broad incumbent in women's health diagnostics, including Aptima molecular assays for chlamydia/gonorrhea — the clinical-gold-standard assays that Visby's at-home PCR test must match in accuracy to maintain credibility with clinicians and payers.
• Abbott: Broad incumbent across rapid and molecular diagnostics (BinaxNOW, ID NOW PCR). Abbott's installed base in clinics and consumer retail channels represents a major competitive and channel-leverage threat to Visby's expansion.
• Becton, Dickinson and Company (BD): Broad incumbent in molecular diagnostics and women's health testing. BD's MAX system and broader diagnostics portfolio represent a large-scale competitor that could enter or expand in the OTC/at-home molecular category.
• Roche: Broad incumbent in molecular diagnostics and STI testing (cobas PCR systems). Roche's depth in centralized PCR could pivot into the OTC / near-patient molecular category that Visby currently leads.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/visbymedical
• Instagraminstagram.com/visbymedical

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds

Investors

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.com