Biofidelity
Biofidelity is a molecular diagnostics company that develops pyrophosphorolysis-based Aspyre and Enspyre technologies for rapid, decentralized genomic biomarker testing in cancer, serving oncologists, pathologists, clinical laboratories, and biopharmaceutical companies through CLIA-certified testing services and research-use reagents.
- Company typePrivate
- Founded2019
- HeadquartersCambridge, United Kingdom
- Headcount51–100
- GTM typeB2B
- OfferingServices
What Biofidelity does
Biofidelity is a Cambridge, UK-based molecular diagnostics company founded in 2019 that has developed a proprietary pyrophosphorolysis-based detection technology for genomic biomarker analysis. The company's product portfolio centers on the Aspyre platform, which detects 114 variants across 11 genes relevant to non-small cell lung cancer (NSCLC) using a four-step workflow that runs on existing qPCR instruments, eliminating the requirement for next-generation sequencing (NGS) infrastructure. The platform achieves 100% specificity, rescues 98% of samples that fail NGS quality control, and delivers next-day results versus the typical 21-day NGS turnaround. Aspyre is commercialized through two channels: a CLIA-certified laboratory-developed test (Aspyre Clinical Test for Lung) offered through Biofidelity's Morrisville, NC laboratory, and research-use-only reagents (Aspyre Lung Reagents) sold to laboratories for decentralized testing. A complementary technology, Enspyre, provides NGS target enrichment that removes up to 99% of background DNA to enable 100x efficiency improvement in sequencing applications including minimal residual disease detection.
The company operates a sales-led go-to-market targeting three primary customer segments: oncologists and thoracic cancer specialists using clinical tests to guide targeted therapy decisions, pathologists and laboratory directors conducting genomic biomarker testing, and biopharmaceutical companies using reagents for clinical trial patient screening. Strategic channel partnerships with CellCarta (global clinical trial exclusive rights) and Fidelis Sustainability Distribution (US VA Medical Centers and military healthcare) extend reach into enterprise and government accounts. Revenue is generated through clinical laboratory testing services, RUO reagent sales, and licensing of Enspyre technology to pharmaceutical companies, CROs, and precision medicine developers. The company has raised approximately $60 million in total funding since inception across seed, Series A, Series A+, and strategic financing rounds, with Octopus Ventures and Agilent Technologies as primary investors. Aspyre and Enspyre core technology is protected by patents granted in the United States, Europe, and China. Biofidelity maintains certifications including CLIA, CAP accreditation, ISO 13485:2016, and clinical laboratory licenses in multiple US states.
Biofidelity firmographics
Firmographics- Name
- Biofidelity
- Legal name
- Biofidelity Ltd
- Website
- https://biofidelity.com
- Company type
- Private
- Founded year
- 2019
- Operating status
- Operating
- Headcount range
- 51–100 employees
- Short description
- Biofidelity is a molecular diagnostics company that develops pyrophosphorolysis-based Aspyre and Enspyre technologies for rapid, decentralized genomic biomarker testing in cancer, serving oncologists, pathologists, clinical laboratories, and biopharmaceutical companies through CLIA-certified testing services and research-use reagents.
- Ownership category
- akta.pro rank
Biofidelity industry classification
Industry- Product category
- Molecular Diagnostics
- NAICS
- In-Vitro Diagnostic Substance Manufacturing (325413)
- SIC
- In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)
- akta.pro primary industry
- Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI)
- akta.pro secondary industry
- Cell-Based & Potency Assays (Bioassays) (HLAGADAH)
Keywords
Where Biofidelity is headquartered
LocationHeadquarters
- HQ city
- Cambridge
- HQ country
- United Kingdom
- HQ region
- Europe
Offices2 records
Markets served
Biofidelity business model
Business model- GTM type
- B2B
- Offering type
- Services
- Cost components
- Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales, Infrastructure
Revenue model
- Clinical Laboratory Testing Services: Aspyre Clinical Test for Lung is offered as a laboratory-developed test through Biofidelity's CLIA-certified laboratory in Morrisville, NC. Healthcare providers submit tissue or blood samples for genomic biomarker analysis, with results returned within 2 days for treatment decision-making.
- Research Use Only Reagent Sales: Aspyre Lung Reagents are sold to research laboratories and biopharma companies for use in NSCLC research. The reagents enable decentralized genomic testing on existing qPCR instrumentation without requiring NGS infrastructure.
- Licensing and Partnership Revenue: Biofidelity licenses its Enspyre technology to pharmaceutical companies, CROs, and precision medicine developers. The company is pursuing an 'Intel Inside' approach for Enspyre commercialization through partnerships.
Pricing tiers
| Model | Billing | Price |
|---|---|---|
| Other | Pay-as-you-go | Aspyre Clinical Test for Lung - Laboratory testing service |
Go-to-market motion1 record
Distribution channels4 records
Marketing channels6 records
Biofidelity product offering
Product offeringCore offering
Biofidelity develops proprietary pyrophosphorolysis-based molecular diagnostic technology sold under the Aspyre® and Enspyre® brands. The company sells research-use reagents (Aspyre Lung Reagents) to laboratories and biopharma companies, operates a CLIA-certified laboratory providing the Aspyre Clinical Test for Lung (a laboratory-developed test for NSCLC biomarker detection from tissue or blood), and licenses Enspyre NGS target enrichment technology to pharma, CROs, and precision medicine developers.
Product overview
Biofidelity offers a unified portfolio of genomic testing products centered on two innovative technologies: Aspyre® and Enspyre®. Aspyre® provides a simplified alternative to NGS for biomarker detection, available as both a clinical laboratory test (Aspyre® Clinical Test for Lung) and research reagents (Aspyre® Lung Reagents). Enspyre® is a complementary NGS enrichment technology that dramatically improves sequencing efficiency. Together, these products serve the complete cancer patient journey from early detection to treatment selection to minimal residual disease monitoring.
Differentiator
Problem solved
Functional benefit
Brands
- Aspyre®: Advanced molecular technology platform for biomarker detection in cancer, designed to simplify genomic analysis and run on existing PCR instruments.
- Aspyre® Lung
- Enspyre®
- Aspyre® Clinical Test for Lung
Products and services
- Aspyre Clinical Test for Lung A CLIA-certified laboratory-developed test providing next-day biomarker results for non-small cell lung cancer (NSCLC) patients. Analyzes DNA and RNA from tissue or blood samples, detecting 114 variants across 11 genes including SNVs/Indels, RNA fusions, and MET exon 14 skipping. Designed for healthcare providers and oncologists requiring rapid treatment decision support.
- Aspyre Lung Reagents Research use only (RUO) reagent kit enabling decentralized NSCLC biomarker testing on existing qPCR platforms. Uses a 4-step workflow to analyze 114 variants across 11 genes including DNA SNVs/Indels and RNA fusions. Sold to research laboratories and biopharma companies.
- Enspyre NGS Enrichment Technology Novel target enrichment technology that removes more than 99% of uninformative background DNA prior to sequencing, enabling 100x improvement in NGS efficiency. Enables detection of thousands of variants at less than 3% of standard sequencing depth. Licensed to pharmaceutical companies, CROs, and precision medicine developers for applications including minimal residual disease (MRD) detection.
- Aspyre Technology Platform Molecular diagnostic platform based on pyrophosphorolysis chemistry that runs on existing qPCR instruments with a 4-step workflow and turnkey data analysis. Detects 114 variants across 11 genes with 100% specificity and rescues 98% of samples that fail NGS quality control.
Quantifiable outcome
- 98% of samples that fail NGS QC are rescued by Aspyre
- +4 more outcomes
Companies that use Biofidelity
Customer profileNamed customers3 records
Segments4 records
Ideal customer profiles5 records
Biofidelity technology and API
TechnologyTechnology focussed Yes
API detail
- Has API
- No
- API docs
- API detail
Core technology
AI maturity
App detail
AI capability2 records
Feature4 records
Biofidelity partnerships and signals
Strategic signalPartnerships
Three partnerships are on record, tiered core.
- CellCartacoreExpanded multi-year global strategic partnership granting CellCarta exclusive rights to offer Aspyre Lung assay in clinical trial settings globally. CellCarta serves as the exclusive clinical trial partner and will deploy the assay across global trials, with potential for future collaboration on Biofidelity's minimal residual disease technology. The partnership enables faster, more cost-effective biomarker testing compared to traditional NGS methods.
- Fidelis Sustainability DistributioncoreDistribution partnership to make Aspyre Lung available to VA Medical Centers and active military institutions across the United States. Fidelis enables access to government healthcare customers for rapid precision genomic testing.
- CellCartacoreInitial strategic partnership agreement to utilize Aspyre Lung in global clinical trials. CellCarta to set up and validate Aspyre Lung in European laboratories first, followed by US-based laboratories, with non-exclusive rights for clinical trials globally.
Scale indicators6 records
Recent moves9 records
Expansion highlights6 records
Biofidelity competitors and assessment
Company assessmentDirect peers
- Exact Sciences: Commercial-stage molecular diagnostics company focused on cancer detection (Cologuard, Oncotype DX). Comparable to Biofidelity as a scaled molecular diagnostics franchise leveraging clinical lab infrastructure and proprietary assays for oncology decision-making.
- NeoGenomics: Specialized oncology-focused clinical laboratory services company offering molecular and genetic testing for cancer. Directly comparable to Biofidelity's CLIA lab service business serving oncologists and pathologists with biomarker profiling.
- Guardant Health: Leading liquid biopsy and precision oncology company (Guardant360, Shield) focused on NGS-based blood-based cancer testing. Comparable to Biofidelity's liquid biopsy work on NSCLC plasma samples and as a developer of decentralized cancer biomarker assays.
- Caris Life Sciences: Molecular science and technology company offering comprehensive molecular profiling (MI Profile, MI Cancer Seek) for oncology. Comparable as a competing molecular profiling service for solid tumors targeting oncologists and biopharma trial sponsors.
- Personalis: Cancer genomics company offering NGS-based tumor profiling (NeXT Personal) and MRD solutions. Comparable to Biofidelity across both tumor profiling and emerging MRD detection, with overlap in NSCLC biomarker testing.
- Natera: Cell-free DNA testing company with Signatera tumor-informed MRD assay and oncology liquid biopsy products. Comparable to Biofidelity on decentralized molecular oncology testing and overlapping MRD roadmap via Enspyre.
Broad incumbents
- Foundation Medicine (Roche): Industry-leading NGS-based comprehensive genomic profiling provider for solid tumors, owned by Roche. Comparable as the dominant incumbent in cancer genomic profiling against which Aspyre competes on speed and cost.
- Tempus: AI-enabled precision medicine company offering NGS-based molecular profiling, clinical trial matching, and data analytics for oncology. Comparable as a broad-scale NGS-based competitor targeting oncologists with comprehensive genomic profiling.
Emerging players
- Resolution Bioscience (Agilent): Acquired by Agilent Technologies in 2021, Resolution Bioscience develops NGS-based liquid biopsy kits for cancer. Highly comparable as a technology platform for decentralized cancer biomarker testing — and notably an Agilent portfolio company, creating a strategic adjacency with Biofidelity's own Agilent-backed strategy.
- Oncocyte: Molecular diagnostics company developing and commercializing tests for transplant monitoring and oncology (DetermaRx, DetermaIO). Comparable as a small-to-mid-cap precision oncology diagnostics company pursuing similar hospital and biopharma channels.
Market position
Strengths5 records
Weaknesses5 records
Competitive moat5 records
Key risks6 records
Key highlights7 records
Customer concentration
Biofidelity social profiles
Digital presenceBiofidelity compliance and trust
Trust signalCompliance7 records
Biofidelity financial estimates
Financial estimateRevenue estimate
Valuation estimate
Biofidelity leadership team
Management profileNumber of profiles
Profiles15 records
Biofidelity funding detail
Funding detailFunding overview
Funding rounds5 records
Investors5 records
Funding detail is available on the Subscription and Enterprise plan.Contact sales →
Biofidelity 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 Biofidelity
What does Biofidelity do?
Biofidelity develops proprietary pyrophosphorolysis-based molecular diagnostic technology sold under the Aspyre® and Enspyre® brands. The company sells research-use reagents (Aspyre Lung Reagents) to laboratories and biopharma companies, operates a CLIA-certified laboratory providing the Aspyre Clinical Test for Lung (a laboratory-developed test for NSCLC biomarker detection from tissue or blood), and licenses Enspyre NGS target enrichment technology to pharma, CROs, and precision medicine developers.
Is Biofidelity a public or private company?
Biofidelity is a private company. It is classified as venture growth investor backed and is currently operating.
When was Biofidelity founded?
Biofidelity was founded in 2019. It employs 51 to 100 people.
Where is Biofidelity based?
Biofidelity is headquartered in Cambridge, United Kingdom, in the Europe region.
How does Biofidelity make money?
Three revenue lines are on record. Clinical Laboratory Testing Services are the primary driver. The others are research Use Only Reagent Sales and licensing and Partnership Revenue.
Who are Biofidelity's main competitors?
Direct peers on record are Exact Sciences, NeoGenomics, Guardant Health, Caris Life Sciences, Personalis and Natera. Broad incumbents are Foundation Medicine (Roche) and Tempus. Emerging players are Resolution Bioscience (Agilent) and Oncocyte.
Does Biofidelity have an API?
No public API is recorded for Biofidelity.
What industry is Biofidelity in?
Biofidelity's product category is Molecular Diagnostics. Its primary akta.pro industry code is HLAGAIAI, Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes), with a secondary code of HLAGADAH, Cell-Based & Potency Assays (Bioassays). Its NAICS code is 325413 and its SIC code is 2835.