Precision Pathology

What Precision Pathology does

Precision Pathology Laboratory Services, LLC is a CAP-accredited and CLIA-certified clinical laboratory headquartered in San Antonio, Texas, operating as a wholly owned subsidiary of bioAffinity Technologies (NASDAQ: BIAF). Founded in 2007 by Dr. Roby P. Joyce and acquired by bioAffinity in September 2023, the laboratory historically provided a broad menu of anatomic and clinical pathology services (respiratory testing, morphological stains, histology, DNA extractions, STI testing, women's and men's health testing, MSI-High cancer testing) and in 2025 strategically discontinued unprofitable service lines to focus on its flagship diagnostic. The lab is best known for CyPath Lung, a noninvasive, sputum-based test for early-stage lung cancer detection that runs on a proprietary flow cytometry platform combined with custom AI-driven analytics and a fluorescent porphyrin (TCPP) that preferentially binds to cancer cells.

CyPath Lung is marketed as a Laboratory Developed Test (LDT) under CPT Proprietary Laboratory Analyses code 0406U, with CMS Clinical Laboratory Fee Schedule reimbursement effective January 2024 at a national allowance historically around $380 per test. Clinical validation in high-risk patients with pulmonary nodules under 20mm demonstrated 92% sensitivity, 87% specificity, and 88% accuracy. The underlying platform is protected by 51 awarded patents across 21 countries, with three additional applications pending, covering both the TCPP labeling chemistry and the analytical methods. In 2024-2026 the company expanded CyPath Lung from a Texas test market into nine states (TX, NJ, OH, PA, MI, NC, CA, FL, AZ), grew ordering pulmonology practices by 139% since January 2024, secured Federal Supply Schedule access for VA and DOD customers, and is conducting a DOD-funded prospective study (NCT05870592) at Brooke Army Medical Center that also supports development of COPD and bronchoscopy companion diagnostics on the same platform.

The business model is per-test fee-for-service reimbursement under CPT 0406U, sold via a direct enterprise field-sales force targeting pulmonology practices, supplemented by self-serve physician and patient portals, channel partnerships (e.g., American Cancer Society awareness campaigns), and government procurement via the Federal Supply Schedule. Primary customers are pulmonologists managing patients with indeterminate pulmonary nodules, high-risk lung cancer screening populations (smokers, former smokers, LDCT-positive patients), and federal healthcare systems (VA, DOD). Pricing is set through the CMS Clinical Lab Fee Schedule, with unit volumes growing 99% YoY in 2025 and 146% YoY in Q1 2026, while CyPath Lung revenue grew 87% YoY in 2025 to a base that, combined with residual services, contributed to consolidated FY2025 revenue of $6.2M and Q1 2026 consolidated revenue of $1.4M (of which $361K was CyPath Lung).

Name

Precision Pathology

Legal name

Precision Pathology Laboratory Services, LLC

Website

https://precisionpath.us

Company type

Private

Founded year

2007

Operating status

Operating

Headcount range

11–50 employees

Short description

Precision Pathology Laboratory Services is a CAP/CLIA-accredited clinical laboratory in San Antonio, Texas and a subsidiary of bioAffinity Technologies, commercializing CyPath Lung, a noninvasive sputum-based AI-enabled lung cancer diagnostic, to pulmonology practices, VA/DOD, and high-risk screening patients across nine U.S. states.

Ownership category

akta.pro rank

Product category

Clinical Pathology Laboratory Services / Cancer Diagnostics

NAICS

Medical Laboratories (621511)

SIC

Services-Medical Laboratories (8071), In Vitro & In Vivo Diagnostic Substances (2835)

akta.pro primary industry

Reference & Esoteric Testing Laboratories (HLAFAMAJ)

akta.pro secondary industries

Specialty & Biomarker Laboratory Services (Immunoassays/Flow/Cytometry) (HLAGAEAB), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Clinical pathology services
• Lung cancer diagnostics
• Flow cytometry testing
• Cancer biomarker testing
• Molecular pathology laboratory

Headquarters

HQ city

San Antonio

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Supply Chain, Infrastructure

Revenue model

1. CyPath Lung Test Sales: Revenue from sales of CyPath Lung diagnostic tests performed at Precision Pathology Laboratory Services. Test revenue grew 87% year-over-year in 2025 and 114% in Q1 2026 to $361,000. Unit sales increased 146% year-over-year in Q1 2026.
2. Pathology Services (Discontinued): General pathology services including respiratory testing, anatomic pathology, morphological stains, histological services, DNA extractions, STI testing, and women's/men's health testing. Strategic discontinuation of unprofitable services in 2025 reduced operating expenses by 9%.
3. Government/FSS Procurement: CyPath Lung available through Federal Supply Schedule for government customers including VA and DOD, providing simplified procurement at contract prices and discounts.

Pricing tiers

Go-to-market motion2 records

Distribution channels4 records

Marketing channels4 records

Core offering

Precision Pathology Laboratory Services is a CAP/CLIA-accredited clinical pathology laboratory that performs and commercializes CyPath Lung, a noninvasive sputum-based diagnostic test for early-stage lung cancer that uses flow cytometry with proprietary fluorescent porphyrin (TCPP) binding and AI-driven analysis of cell populations. The lab also provides complementary anatomic pathology, MSI-High cancer biomarker testing, respiratory testing, histological services, DNA extractions, STI testing, and women's and men's health testing as contracted clinical laboratory services.

Product overview

Precision Pathology Laboratory Services operates as a CAP/CLIA accredited clinical laboratory and subsidiary of bioAffinity Technologies. The primary commercial product is CyPath Lung, a noninvasive lung cancer diagnostic test using flow cytometry and AI analysis of sputum samples. The laboratory also provides supporting pathology services including MSI-High cancer testing, solid tumor diagnosis, respiratory testing, anatomic pathology, morphological stains, histological services, DNA extractions, STI testing, and women's and men's health testing. CyPath Lung is marketed as a Laboratory Developed Test (LDT) and generates results through automated AI-driven analysis of flow cytometry data.

Differentiator

Problem solved

Functional benefit

Products and services

• CyPath Lung A noninvasive sputum-based diagnostic test for early-stage lung cancer that uses flow cytometry combined with artificial intelligence and a fluorescent porphyrin (TCPP) to detect cancer cells; demonstrated 92% sensitivity, 87% specificity, and 88% accuracy in high-risk patients with lung nodules under 20mm. Sold to pulmonology practices and federal customers through Federal Supply Schedule under CPT PLA code 0406U with at-home sample collection.
• MSI-High Cancer Testing Micro-Satellite Instability (MSI) testing to identify patients with deficient MMR proteins (MLH1, MSH2, MSH6, PMS2) in colorectal, endometrial, and other advanced cancers; used as a prognostic and predictive biomarker for treatment planning and immunotherapy response. Available to physician clients through the Precision Pathology services test menu.
• Precision Pathology Laboratory Services (PPLS) CAP/CLIA-accredited clinical laboratory providing comprehensive anatomic pathology, solid tumor diagnosis, breast specialist pathology, respiratory testing (SARS-CoV-2, influenza), morphological stains, histological services, DNA extractions, STI testing, and women's and men's health testing. Acquired by bioAffinity Technologies in September 2023; unprofitable lines strategically discontinued in 2025 to focus on CyPath Lung.

Quantifiable outcome

• 92% sensitivity, 87% specificity, 88% accuracy for detecting lung cancer in small indeterminate nodules under 20mm
• +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

AI capability3 records

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• Brooke Army Medical Center (BAMC)coreStrategic or Co-development Partner · 1 April 2024Collaboration for lung cancer and COPD diagnostic test development. BAMC currently enrolling DOD beneficiaries at high risk for lung cancer in prospective observational study (NCT05870592). Research on BAL and sputum samples for lung cancer and COPD is part of collaboration with bioAffinity Technologies.
• American Cancer Society (ACS)coreStrategic or Co-development Partner · 1 November 2023Partnership expanded from November 2023 launch to raise funding for ACS Lung Quality Improvement initiative to increase lung cancer screening rates. Campaign highlights value of early screening and provides information about CyPath Lung. Expanded geographic reach to include ACS Lung QI sites across the country.

Scale indicators8 records

Recent moves7 records

Expansion highlights6 records

Emerging players

• Guardant Health: Guardant Health's Guardant360 blood-based liquid biopsy test is increasingly used to characterize lung cancer at diagnosis and recurrence, partially overlapping with CyPath Lung in addressing the pulmonology/lung cancer diagnostic pathway through a different specimen type.
• Optellum: Optellum applies AI to lung CT imaging to risk-stratify pulmonary nodules, competing for the same pulmonology decision point and clinical workflow as CyPath Lung but using imaging instead of sputum as input.

Direct peers

• Veracyte: Veracyte markets the Percepta Genomic Sequencing Test, a non-invasive diagnostic intended to help pulmonologists assess the malignancy risk of lung nodules. Both companies sell LDT-style diagnostic tests that compete for the same pulmonology ordering decision and use similar clinical evidence claims and CPT reimbursement strategies.
• Biodesix: Biodesix develops and commercializes blood-based and proteomic lung cancer diagnostic tests (e.g., Nodify Lung) targeting the same pulmonology customers and pulmonary-nodule management use case as CyPath Lung, using a specialty reference lab distribution model with proprietary reimbursement coverage.
• NeoGenomics: NeoGenomics operates a specialty oncology reference laboratory selling proprietary and esoteric cancer tests to oncologists and pulmonologists. It is comparable to Precision Pathology in operating model, payer relationships, and emphasis on proprietary oncology assays.
• Oncimmune: Oncimmune's EarlyCDT-Lung is a blood-based LDT for early lung cancer detection in high-risk patients, directly overlapping Precision Pathology's go-to-market motion of supporting pulmonologists managing indeterminate nodules.

Others

• bioMérieux: bioMérieux is a global in vitro diagnostics company supplying biomarker reagents and assays, including immunoassays and microbiology tests used by hospitals and reference labs. Comparable to Precision Pathology as an adjacent IVD participant whose technologies intersect with biomarker-based diagnostics.

Broad incumbents

• Quest Diagnostics: Quest Diagnostics is the largest US clinical reference lab offering advanced oncology and esoteric testing nationwide. Precision Pathology competes for pulmonology esoteric test volume with Quest's specialty/cancer menu using a similar LDT-plus-reimbursement strategy at smaller scale.
• Exact Sciences: Exact Sciences (Cologuard) operates a high-growth proprietary cancer diagnostics franchise with direct physician sales and centralized lab processing. Comparable in business model and market-entry tactics to a precision diagnostic startup scaled across sales channels.
• Laboratory Corporation of America (Labcorp): Labcorp is a national clinical laboratory network with extensive specialty and oncology testing capabilities. It provides the deepest commercial alternative to Precision Pathology's specialty lung cancer test across ordering channels.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights6 records

Customer concentration

• Facebookfacebook.com/precisionpath
• LinkedInlinkedin.com/company/precision-pathology-services

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

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 Precision Pathology