Proof Diagnostics
Proof Diagnostics, founded in 2019 and acquired by Ginkgo Bioworks in February 2024, developed CRISPR-based molecular diagnostic platforms and proprietary OMEGA RNA-programmable nuclease technology for point-of-care infectious disease testing and gene therapy applications.
- Company typePrivate
- Founded2019
- HeadquartersCambridge, United States
- Headcount11–50
- GTM typeB2B
- OfferingHardware or Manufacturing
What Proof Diagnostics does
Proof Diagnostics was a Cambridge, Massachusetts-based health technology company founded in 2019 by leading CRISPR and gene editing researchers, including Dr. Feng Zhang of the Broad Institute of MIT and Harvard, Drs. Omar Abudayyeh and Jonathan Gootenberg of the McGovern Institute for Brain Research at MIT, and CEO Sid Shenai. The company developed a portable, CRISPR-based molecular diagnostic platform — the Proof Lab Test System — designed to deliver results within 18 minutes for SARS-CoV-2, Flu A/B, RSV, and oncology applications at the point of care. Its underlying scientific asset was the OMEGA (Obligate Mobile Element Guided Activity) RNA-programmable nuclease platform, a class of non-Cas enzymes that are smaller, more diverse, and more robust than conventional CRISPR Cas nucleases, making them more amenable to delivery into cells for gene editing applications.
The company's commercial model combined hardware sales of portable diagnostic devices for healthcare providers and point-of-care facilities with a longer-term licensing and tool-development pathway for its OMEGA enzyme libraries. The company submitted an FDA Emergency Use Authorization application for its COVID-19 diagnostic in April 2022 and raised a $45 million Series A from ARCH Venture Partners, F-Prime, and Madrona. Following Ginkgo Bioworks' (NYSE: DNA) acquisition in February 2024, Proof's OMEGA nuclease libraries have been integrated into Ginkgo's Gene Therapy Services platform to serve pharmaceutical and biotechnology customers developing genetic medicines, while the portable diagnostic system has been incorporated into Ginkgo's biosecurity and cell programming platform. As of April 2025, Proof Diagnostics continues to operate as a semi-autonomous subsidiary within Ginkgo Bioworks, retaining its own executive team.
Proof Diagnostics firmographics
Firmographics- Name
- Proof Diagnostics
- Legal name
- Proof Diagnostics, Inc.
- Website
- https://proofdx.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Acquired
- Headcount range
- 11–50 employees
- Short description
- Proof Diagnostics, founded in 2019 and acquired by Ginkgo Bioworks in February 2024, developed CRISPR-based molecular diagnostic platforms and proprietary OMEGA RNA-programmable nuclease technology for point-of-care infectious disease testing and gene therapy applications.
- Ownership category
- akta.pro rank
Where Proof Diagnostics is headquartered
LocationHeadquarters
- HQ city
- Cambridge
- HQ country
- United States
- HQ region
- North America
Markets served
Proof Diagnostics business model
Business model- GTM type
- B2B
- Offering type
- Hardware or Manufacturing
- Cost components
- Technology or R&D, Personnel, Operations, Marketing or Sales
Revenue model
- Molecular Diagnostic Testing Products: Proof Diagnostics developed and commercialized molecular diagnostic tests using CRISPR technology for infectious disease detection. The company submitted an EUA application to the FDA for its Proof Lab Test System, targeting point-of-care testing markets.
- Technology Licensing (via Acquisition): Following acquisition by Ginkgo Bioworks in February 2024, Proof's OMEGA nuclease technology is being integrated into Ginkgo's Gene Therapy Services platform, providing customers with new gene editing tools for therapeutic applications.
Go-to-market motion1 record
Distribution channels1 record
Marketing channels2 records
Proof Diagnostics product offering
Product offeringCore offering
Proof Diagnostics develops a portable, CRISPR-based molecular diagnostic test system (the Proof Lab Test System) that delivers infectious disease detection results within 18 minutes at the point of care. The company's foundational IP is its proprietary OMEGA (Obligate Mobile Element Guided Activity) RNA-programmable, non-Cas nuclease libraries, which are significantly smaller and more diverse than conventional CRISPR Cas nucleases and are now deployed via Ginkgo Bioworks' Gene Therapy Services for therapeutic gene editing applications.
Product overview
Proof Diagnostics offers a CRISPR-based molecular diagnostic platform designed for portable, rapid point-of-care testing. The core product is the Proof Lab Test System, a molecular diagnostic device that delivers results in 18 minutes for infectious diseases including SARS-CoV-2, Flu A/B, and RSV. Underlying this diagnostic work is the company's OMEGA (Obligate Mobile Element Guided Activity) RNA-programmable nuclease technology—a smaller, more diverse class of programmable nucleases compared to CRISPR Cas systems. In February 2024, Proof Diagnostics was acquired by Ginkgo Bioworks, which is integrating the OMEGA nuclease technology into its gene therapy services to provide customers with expanded gene editing tools.
Differentiator
Problem solved
Functional benefit
Products and services
- Proof Lab Test System A portable, CRISPR-based molecular diagnostic test system designed to provide fast, accurate results within 18 minutes for infectious diseases including SARS-CoV-2, with intended expansion to Flu A/B, RSV, and oncology applications. Built for simple, scalable point-of-care testing in healthcare facilities, clinics, and decentralized settings.
Quantifiable outcome
- Results delivered within 18 minutes for COVID-19 molecular diagnostic testing
Companies that use Proof Diagnostics
Customer profileSegments2 records
Ideal customer profiles2 records
Proof Diagnostics technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
Feature3 records
Proof Diagnostics partnerships and signals
Strategic signalScale indicators1 record
Recent moves6 records
Expansion highlights6 records
Proof Diagnostics competitors and assessment
Company assessmentDirect peers
- Sherlock Biosciences: CRISPR-based molecular diagnostics company developing SHERLOCK and INSPECTR platforms for infectious disease and oncology detection. Directly comparable to Proof's CRISPR diagnostic platform and similar Cambridge-based, founder-led positioning.
- Mammoth Biosciences: CRISPR-based diagnostics and gene-editing therapeutics company co-founded by Jennifer Doudna. Directly comparable on CRISPR diagnostics technology and CRISPR-based platform play.
- Caspr Biotech: CRISPR-based diagnostics company developing portable molecular tests for infectious diseases. Comparable to Proof's portable, CRISPR-based point-of-care testing strategy.
- Cue Health: Portable molecular point-of-care diagnostic system for respiratory and other infectious diseases. Directly comparable to Proof Lab Test System on form factor, target disease menu, and POC channel.
- Visby Medical: Developer of single-use, PCR-based portable molecular diagnostic tests for infectious diseases. Comparable to Proof's portable molecular POC platform on use case and customers.
- Arbor Biotechnologies: Discovery and development of novel CRISPR nucleases and gene editors for therapeutic applications. Closely comparable to Proof's OMEGA nuclease platform and is already a Ginkgo partner in precision gene editors.
Broad incumbents
- Cepheid (Danaher): Established molecular diagnostics incumbent with the GeneXpert system widely deployed across hospitals and POC settings. Represents the entrenched competition Proof must displace in clinical molecular diagnostics.
- Abbott Diagnostics: Major diagnostics incumbent offering the ID NOW rapid molecular POC platform and broad respiratory testing menu. Represents scale and channel competition against Proof Lab Test System.
Emerging players
- Editas Medicine: Clinical-stage gene editing company co-founded by Dr. Feng Zhang. Comparable on programmable nuclease modality and shared founder pedigree, though focused on therapeutic development rather than diagnostics.
- Beam Therapeutics: Clinical-stage base editing company developing programmable precision genetic medicines. Comparable as a programmable nuclease platform player pursuing therapeutic applications, similar to OMEGA's gene therapy trajectory.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat4 records
Key risks6 records
Key highlights6 records
Customer concentration
Proof Diagnostics social profiles
Digital presenceProof Diagnostics financial estimates
Financial estimateRevenue estimate
Valuation estimate
Proof Diagnostics leadership team
Management profileNumber of profiles
Profiles6 records
Proof Diagnostics funding detail
Funding detailFunding overview
Funding rounds2 records
Investors4 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Proof Diagnostics 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 Proof Diagnostics
What does Proof Diagnostics do?
Proof Diagnostics develops a portable, CRISPR-based molecular diagnostic test system (the Proof Lab Test System) that delivers infectious disease detection results within 18 minutes at the point of care. The company's foundational IP is its proprietary OMEGA (Obligate Mobile Element Guided Activity) RNA-programmable, non-Cas nuclease libraries, which are significantly smaller and more diverse than conventional CRISPR Cas nucleases and are now deployed via Ginkgo Bioworks' Gene Therapy Services for therapeutic gene editing applications.
Is Proof Diagnostics a public or private company?
Proof Diagnostics is a private company. It is classified as corporate owned and is currently acquired.
When was Proof Diagnostics founded?
Proof Diagnostics was founded in 2019. It employs 11 to 50 people.
Where is Proof Diagnostics based?
Proof Diagnostics is headquartered in Cambridge, United States, in the North America region.
How does Proof Diagnostics make money?
Two revenue lines are on record. Molecular Diagnostic Testing Products are the primary driver. The others are technology Licensing (via Acquisition).
Who are Proof Diagnostics's main competitors?
Direct peers on record are Sherlock Biosciences, Mammoth Biosciences, Caspr Biotech, Cue Health, Visby Medical and Arbor Biotechnologies. Broad incumbents are Cepheid (Danaher) and Abbott Diagnostics. Emerging players are Editas Medicine and Beam Therapeutics.
Does Proof Diagnostics have an API?
No public API is recorded for Proof Diagnostics.