BioAffinity Technologies

What BioAffinity Technologies does

BioAffinity Technologies is a publicly traded (NASDAQ: BIAF) cancer diagnostics company founded in 2014 and headquartered in San Antonio, Texas. It develops and commercializes CyPath Lung, a noninvasive, Laboratory Developed Test (LDT) that detects early-stage lung cancer from patient-collected sputum samples. The test combines automated flow cytometry with a proprietary machine-learning pipeline and a patented fluorescent porphyrin biomarker (TCPP, meso-tetra(4-carboxyphenyl) porphine) that selectively labels cancer-associated cells via the CD320 receptor. Published clinical validation shows 92% sensitivity, 87% specificity, 88% accuracy, and 99% negative predictive value in high-risk patients with small pulmonary nodules under 20mm (AUC 0.94).

CyPath Lung is sold per-test at $1,900 through the company's wholly owned Precision Pathology Laboratory Services (PPLS) subsidiary, a CAP-accredited, CLIA-certified lab in San Antonio. Reimbursement is in place from Medicare (added to the 2024 clinical lab fee schedule), commercial payers, and the U.S. Federal Supply Schedule (FSS/GSA Contract #36F79725D0005), giving direct procurement access to ~1,400 Veterans Health Administration facilities and the DoD Military Health System. The company sells through a direct field sales force led by VP of Sales Dallas Coleman, and via co-marketing relationships with academic medical centers such as Cleveland Clinic and military treatment facilities including Brooke Army Medical Center (BAMC).

FY2025 consolidated revenue was $6.2M, down from $9.4M in 2024 due to the strategic discontinuation of unprofitable legacy pathology services, while CyPath Lung testing revenue grew 87% to $963K on 1,200+ tests. Q1 2026 CyPath Lung unit volume was up 146% YoY. The company reported a 2025 net loss of $14.9M and, as of Q1 2026, held only $3.1M in cash, with management flagging substantial doubt about its ability to continue as a going concern without additional financing beyond June 2026. The company is conducting a DoD-partially-funded longitudinal clinical study across up to 20 VA and military sites (first patient enrolled March 2026) and holds 18 awarded and 33 pending patents globally. The IP portfolio also covers siRNA-based cancer therapeutics (U.S. Patent No. 12,305,171), establishing a longer-term therapeutic optionality beyond the core diagnostic franchise.

Name

BioAffinity Technologies

Legal name

bioAffinity Technologies, Inc.

Website

https://bioaffinitytech.com

Company type

Public

Founded year

2014

Operating status

Operating

Headcount range

51–100 employees

Short description

BioAffinity Technologies (NASDAQ: BIAF) is a San Antonio-based cancer diagnostics company that develops and commercializes CyPath Lung, a noninvasive flow cytometry + AI sputum test for early-stage lung cancer detection, sold primarily to pulmonologists, the VA, and the DoD through its CAP/CLIA-certified PPLS lab subsidiary.

Ownership category

akta.pro rank

Product category

Cancer Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071)

akta.pro primary industry

Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

akta.pro secondary industries

Proteomics & Biomarker Analytical Testing (HLAGADAG), Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB)

Keywords

• Lung cancer diagnostics
• Flow cytometry testing
• Laboratory developed tests
• Pathology laboratory services
• Noninvasive cancer screening

Headquarters

HQ city

San Antonio

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Operations, Marketing or Sales

Revenue model

1. CyPath Lung laboratory developed test (LDT) revenue: Recurring per-test revenue from CyPath Lung, a Laboratory Developed Test (LDT) sold to physicians, hospitals, and federal health systems. Reimbursed by Medicare at $1,900 per test (added to 2024 clinical laboratory fee schedule) and by commercial payers. Revenue from this test surged 87% in 2025 to $963,000 with over 1,200 tests delivered.
2. Precision Pathology Laboratory Services (PPLS) anatomic and clinical pathology revenue: Pathology services including breast pathology, cytopathology, dermatopathology, gastrointestinal pathology, general surgical pathology, genitourinary pathology, and other lab services through CAP-accredited, CLIA-certified PPLS subsidiary. Strategic discontinuation of unprofitable pathology services (gynecological/STD testing) and other lower-margin services in 2025 reduced total consolidated revenue from $9.4M (2024) to $6.2M (2025).
3. Warrant inducement and equity-based financing proceeds (capital raising): Recurring registered direct offerings, private placements, warrant inducement transactions (e.g., $1.4M warrant inducement Feb 2025; $1.75M Aug 2024; $2.5M Mar 2024; $2.6M/$2.66M Oct 2024; $1.8M Oct 2025; $3.25M May 2025; $3.2M Jun 2026). Approximately $16.9M in gross proceeds raised in 2025 alone. Used to fund operations and growth.

Pricing tiers

Go-to-market motion3 records

Distribution channels4 records

Marketing channels9 records

Core offering

BioAffinity Technologies commercializes CyPath Lung, a noninvasive Laboratory Developed Test (LDT) that uses flow cytometry plus an AI/ML algorithm combined with the proprietary fluorescent porphyrin TCPP to detect early-stage lung cancer from patient-collected sputum samples. The test is processed at its wholly owned CAP-accredited, CLIA-certified subsidiary Precision Pathology Laboratory Services (PPLS), which also provides anatomic and clinical pathology services (breast, cytopathology, dermatopathology, GI, surgical, genitourinary, molecular testing).

Differentiator

Problem solved

Functional benefit

Brands

• CyPath Lung: Noninvasive flow cytometry + AI sputum-based diagnostic test for early-stage lung cancer detection, marketed as a Laboratory Developed Test (LDT) demonstrating 92% sensitivity, 87% specificity, and 88% accuracy in patients with small indeterminate pulmonary nodules.
• Precision Pathology Laboratory Services (PPLS)

Products and services

• CyPath Lung CyPath Lung is a noninvasive, at-home sputum-based Laboratory Developed Test (LDT) that uses flow cytometry combined with an AI/ML algorithm and the proprietary fluorescent porphyrin TCPP to label cancer-associated cells and detect early-stage lung cancer. It is indicated for high-risk patients with indeterminate pulmonary nodules (6-29 mm) as a follow-up to low-dose CT screening, demonstrating 92% sensitivity, 87% specificity, and 99% NPV in patients with nodules under 20 mm. It is sold to pulmonologists, primary care physicians, hospitals, and federal health systems at $1,900 per test with Medicare reimbursement on the 2024 clinical lab fee schedule.
• Precision Pathology Laboratory Services (PPLS) Precision Pathology Laboratory Services is bioAffinity Technologies' wholly owned CAP-accredited, CLIA-certified clinical pathology laboratory in San Antonio, Texas, offering anatomic pathology (breast, cytopathology, dermatopathology, gastrointestinal, general surgical, genitourinary), molecular testing, morphological staining, and histological services to outpatient physician practices and hospitals. In 2025, bioAffinity strategically discontinued unprofitable pathology services (gynecological/STD testing) and reduced PPLS workforce by 38% to refocus on higher-margin services and CyPath Lung commercialization.

Quantifiable outcome

• 92% sensitivity, 87% specificity, 88% accuracy, 99% NPV in detecting lung cancer in high-risk patients with small pulmonary nodules <20 mm (published clinical trial)
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Eleven partnerships are on record, tiered flagship and core.

• PhilipsflagshipGTM or Marketing Partner · 16 June 2026Co-participant in the July 21, 2026 NAVREF-hosted webinar on lung health screening for U.S. veterans, alongside 4DMedical and bioAffinity. Discusses advances in mobile CT screening, CyPath Lung testing, and functional lung imaging for veteran populations at increased risk for lung cancer under the PACT Act.
• 4DMedicalflagshipGTM or Marketing Partner · 16 June 2026Co-participant in the July 21, 2026 NAVREF-hosted veteran lung health webinar alongside Philips, RWJBarnabas Health, and bioAffinity. Discusses functional lung imaging advances for veteran populations.
• NAVREF (National Association of Veterans' Research and Education Foundations)coreGTM or Marketing Partner · 16 June 2026Hosts the July 21, 2026 webinar on lung health screening and early detection for veterans, with bioAffinity, Philips, 4DMedical, and RWJBarnabas Health as featured clinical expert participants. Webinar addresses veterans at increased risk for lung cancer under the PACT Act.
• RWJBarnabas HealthcoreGTM or Marketing Partner · 16 June 2026Featured clinical expert at the July 21, 2026 NAVREF webinar on lung health screening for U.S. veterans, contributing perspectives alongside Philips, 4DMedical, and bioAffinity.
• Society for Advanced BronchoscopycoreGTM or Marketing Partner · 2 June 2026Hosted a live webinar on June 16, 2026, featuring a multidisciplinary physician panel discussing the real-world clinical use of bioAffinity's CyPath Lung cancer test. Panel presented how the test is being incorporated into pulmonary, oncology, and surgical practices.
• Cleveland ClinicflagshipGTM or Marketing Partner · 16 April 2026Hosted the 'Advances in Early Lung Cancer Detection' symposium on April 16, 2026, where bioAffinity's CyPath Lung test was featured, with Chief Medical Officer Gordon Downie participating in a panel on lung nodule management.
• Brooke Army Medical Center (BAMC)flagshipStrategic or Co-development Partner · 25 February 2026Multi-study partner: (1) Validation study of CyPath Lung on sputum samples obtained via tracheal/bronchial suctioning during bronchoscopy (30-50 patients, results expected mid-2026); (2) 40-patient collaborative pilot study for asthma and COPD diagnostics; (3) Site in large-scale longitudinal clinical trial (DoD-funded, up to 20 sites at VA/military hospitals).
• Village Oaks Pathology Services, P.A.coreStrategic or Co-development Partner · 22 December 2025Succession agreement where Dr. Roby P. Joyce transferred 100% of his ownership interest in Village Oaks Pathology Services, P.A. to Dr. James Humphreys, with bioAffinity's PPLS subsidiary as a party. Restricts transfer of equity interests without prior written consent. Village Oaks/PPLS is the operational lab arm for CyPath Lung commercialization.
• American Cancer Society National Lung Cancer Roundtable (NLCRT)coreGTM or Marketing Partner · 3 December 2025Showcased bioAffinity's CyPath Lung test at the American Cancer Society NLCRT, demonstrating three cases where the test successfully identified Stage 1A lung cancer, highlighting its sensitivity, specificity, and accuracy in improving diagnosis and patient outcomes.
• Los Alamos National LaboratorycoreStrategic or Co-development PartnerOriginal research site (1988-1992) where porphyrin TCPP was identified as particularly well-suited for lung cancer detection; foundational research originating from LANL led to the founding of bioAffinity Technologies in 2014 to commercialize this technology.
• Precision Pathology Laboratory Services (PPLS)flagshipOEM/ Whitelabel/ Licensing PartnerWholly owned subsidiary of bioAffinity Technologies, originally acquired September 2023 for $3.5 million. Operates as a CAP-accredited, CLIA-certified clinical pathology laboratory marketing CyPath Lung as a Laboratory Developed Test (LDT) for physicians in outpatient settings. Located in San Antonio, Texas. Provides anatomic pathology, morphological staining, histological services, and molecular testing.

Scale indicators13 records

Recent moves9 records

Expansion highlights6 records

Broad incumbents

• GRAIL: GRAIL developed Galleri, a multi-cancer early detection blood test, and is the most prominent player in the emerging MCED category that bioAffinity's platform could eventually intersect.
• Guardant Health: Guardant Health is a leading liquid biopsy company (Guardant360, Shield, Reveal) developing blood-based cancer detection tests. As a broad incumbent in oncology diagnostics with significantly greater resources, it represents both a competitive threat and a benchmark for the lung cancer screening opportunity.
• Exact Sciences: Exact Sciences (Cologuard, Oncotype, Riskguard) is the largest cancer screening franchise with FDA-approved, Medicare-reimbursed diagnostics. Its scale, reimbursement infrastructure, and pipeline into multi-cancer early detection make it the most relevant broad incumbent comparable.
• Natera: Natera is a molecular diagnostics company offering Signatera (MRD), Vantage, Empower, and other tests. Its large-scale oncology testing business and direct-to-physician sales motion are comparable to bioAffinity's commercialization model.
• NeoGenomics: NeoGenomics operates a large oncology-focused clinical laboratory with broad test menus including lung cancer panels. Its CAP-accredited lab infrastructure and CLIA-certified testing services overlap with bioAffinity's PPLS subsidiary operations.

Direct peers

• Biodesix: Biodesix is a lung cancer diagnostics company offering blood-based and proteomic tests (e.g., VeriStrat, GeneStrat, Nodify Lung) used to manage indeterminate pulmonary nodules — the same clinical decision point addressed by bioAffinity's CyPath Lung, making it the closest direct comparable.
• Veracyte: Veracyte is a genomic diagnostics company with the Afirma thyroid test and a growing oncology franchise (Decipher Prostate, Prosigna, Percepta for lung nodules). Percepta directly competes with CyPath Lung in indeterminate lung nodule management.

Emerging players

• Oncocyte: Oncocyte is a molecular diagnostics company with DetermaDx (lung cancer) and DetermaIO/DetermaCNI tests focused on oncology treatment decisions, providing a comparable lung-cancer diagnostic offering to bioAffinity.
• Freenome: Freenome is an early-stage multi-cancer early detection company developing blood-based screening tests for colorectal and other cancers. It competes indirectly with bioAffinity's mission of non-invasive early cancer detection.
• LungLife AI: LungLife AI (formerly Cynvenio) is a small-cap lung cancer diagnostics company developing a blood-based test for early lung cancer detection, making it a closely comparable emerging peer in the same target indication.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks7 records

Key highlights7 records

Customer concentration

• Xx.com/bioaffinity
• LinkedInlinkedin.com/company/bioaffinitytechnologies

Revenue estimate

Valuation estimate

Number of profiles

Profiles13 records

Subsidiaries2 records

Funding overview

Funding rounds14 records

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 BioAffinity Technologies