Biofidelity

Biofidelity

Is this your company? Claim your profile to update info and connect with investors.
Claim profile

Private Company

Total funding raised: $99.5M

Overview

Biofidelity is a private, commercial-stage diagnostics company addressing critical gaps in cancer genomic testing. Its proprietary technology platform underpins two main product lines: the Aspyre® Clinical Test (a Laboratory Developed Test for NSCLC) and Enspyre®, forming an end-to-end solution from early detection to treatment monitoring. The company's assays are distinguished by their simplicity, speed (2-day turnaround), and ability to work with challenging samples, positioning it to capture share in the rapidly growing precision oncology market. Biofidelity operates a CAP-accredited, CLIA-certified lab in the US and sells reagents for research use.

Oncology

Technology Platform

Proprietary molecular platform enabling simultaneous DNA and RNA analysis from a single assay (tissue or blood) for sensitive, specific, and rapid detection of cancer biomarkers.

Funding History

5
Total raised:$99.5M
Series B$40M
Series A$25M
Series A$25M
Seed$4.5M

Opportunities

The large and growing precision oncology market is hindered by complex, slow testing; Biofidelity's simple, fast, and reliable platform is positioned to capture share by improving clinical adoption.
Expanding its Aspyre panels beyond lung cancer and commercializing Enspyre for early detection and MRD represent significant long-term growth avenues in multi-billion dollar markets.

Risk Factors

Intense competition from established NGS and large reference lab players poses a significant commercial barrier.
Navigating complex regulatory and reimbursement landscapes for expansion, and convincing the clinical community to adopt a new technology platform over entrenched standards, are key execution risks.

Competitive Landscape

Biofidelity competes in the comprehensive genomic profiling space against large-cap players like Foundation Medicine (Roche) and Guardant Health, as well as NGS platform companies like Illumina and Thermo Fisher. Its differentiation is based on assay simplicity, rapid turnaround, and combined DNA/RNA analysis from a single test, targeting workflow inefficiencies in current standard-of-care.