Sherlock Biosciences
Sherlock Biosciences is a pioneering company in molecular diagnostics, leveraging engineering biology, CRISPR, and synthetic biology to develop rapid, accurate, and affordable diagnostic tests. Owned by OraSure Technologies, it aims to democratize and decentralize testing, making health information accessible to all. The company has a strong IP portfolio, innovative platforms like SHERLOCK™ and INSPECTR™, and a global presence with manufacturing facilities and strategic partnerships. Sherlock Biosciences is committed to transforming healthcare by providing tools for infectious disease detection, cancer early detection, treatment monitoring, and more, with a focus on global health impact.
Industries
Nr. of Employees
medium (51-250)
Sherlock Biosciences
Products
Disposable OTC molecular test for Chlamydia and Gonorrhea
A single-use, instrument-free molecular diagnostic intended for over-the-counter self-collection and testing that analyzes nucleic acids from self-collected swabs and provides results in under 30 minutes.
Instrument-free, single-use molecular diagnostic platform
A disposable molecular test platform combining rapid amplification chemistries with instrument-free readouts to deliver lab-quality molecular results at the point-of-need in minutes.
Manufacturing capacity for diagnostic devices (UK facility)
36,000 sq. ft. ISO 13485-certified manufacturing campus with Class 8 clean rooms validated to produce millions of disposable molecular diagnostic devices and associated reagent and lateral flow components.
Disposable OTC molecular test for Chlamydia and Gonorrhea
A single-use, instrument-free molecular diagnostic intended for over-the-counter self-collection and testing that analyzes nucleic acids from self-collected swabs and provides results in under 30 minutes.
Instrument-free, single-use molecular diagnostic platform
A disposable molecular test platform combining rapid amplification chemistries with instrument-free readouts to deliver lab-quality molecular results at the point-of-need in minutes.
Manufacturing capacity for diagnostic devices (UK facility)
36,000 sq. ft. ISO 13485-certified manufacturing campus with Class 8 clean rooms validated to produce millions of disposable molecular diagnostic devices and associated reagent and lateral flow components.
Services
Clinical study execution for diagnostic IVDs
Design and conduct of multicenter clinical studies comparing point-of-need disposable molecular tests against central-lab PCR standards, including lay-user usability studies.
Biomanufacturing and device production
ISO 13485-aligned manufacturing with Class 8 clean rooms for validation and production of disposable molecular diagnostic devices, lyophilized reagents, and lateral flow components.
Regulatory and commercialization support for diagnostics
Execution of regulatory strategies including submissions for marketing authorization, emergency use pathways, CE marking, and CLIA waiver requests to enable market entry of point-of-need diagnostics.
Clinical study execution for diagnostic IVDs
Design and conduct of multicenter clinical studies comparing point-of-need disposable molecular tests against central-lab PCR standards, including lay-user usability studies.
Biomanufacturing and device production
ISO 13485-aligned manufacturing with Class 8 clean rooms for validation and production of disposable molecular diagnostic devices, lyophilized reagents, and lateral flow components.
Regulatory and commercialization support for diagnostics
Execution of regulatory strategies including submissions for marketing authorization, emergency use pathways, CE marking, and CLIA waiver requests to enable market entry of point-of-need diagnostics.
Expertise Areas
- CRISPR-based diagnostic development
- Synthetic biology-enabled instrument-free diagnostics
- Point-of-care and over-the-counter molecular test development
- Biomanufacturing and ISO 13485 production for diagnostics
Key Technologies
- CRISPR-Cas nucleic acid detection (Cas12/Cas13 collateral cleavage)
- Isothermal/rapid molecular amplification chemistries
- Synthetic biology-based, instrument-free assay platforms
- Disposable single-use molecular diagnostic devices