🌍 The Market (1)(2)(3)(4)
Lung cancer remains one of the largest and most persistent challenges in healthcare.
The company highlights 2.48 million new cases worldwide in 2022 and approximately 1.8 million deaths annually.
In the United States, bioAffinity
Technologies, Inc. (Nasdaq: BIAF) points to estimates that 19.3 million Americans should receive annual lung cancer screening.
But screening alone does not solve the clinical dilemma.
Imaging frequently identifies lung nodules that are not immediately clear. Those findings can lead to repeated CT scans, prolonged surveillance, patient anxiety, and sometimes invasive procedures.
The company’s materials project
that indeterminate pulmonary nodules requiring follow-up may grow from 2.9 million in 2025 to 4.7 million by 2030, a 62% increase.
That is not theoretical demand.
It is a growing pool of patients where physicians need better tools to guide decisions.
It is also why bioAffinity Technologies, Inc. (Nasdaq: BIAF) continues to focus on the “in-between” zone of lung nodule management — the stage where
nodules are detected but the next clinical step is uncertain.
The economic footprint around this problem is already significant.
The company cites a lung cancer diagnostics market estimated at $20 billion in 2023 and projected to reach $38 billion by 2034.
Large market.
Growing patient volume.
A persistent clinical need.
That is the backdrop where diagnostic tools designed to fit clinical
workflow can gain traction.
🔬 The Company (1)(2)(3)(4)
At the center of the company’s commercial strategy is CyPath® Lung.
The company describes CyPath® Lung as a noninvasive diagnostic test that uses flow cytometry combined with proprietary artificial intelligence to analyze sputum samples for cell populations
associated with lung cancer.
The test is designed with practical clinical considerations in mind.
Patients collect sputum samples at home, send them to the lab overnight, and receive results within approximately three days after the sample arrives.
Clinical data cited by the company reports:
92% sensitivity
87% specificity
88% accuracy
99%
negative predictive value
for patients at high risk for lung cancer with small pulmonary nodules under 20 millimeters.
The 99% negative predictive value is particularly important in clinical practice.
It supports the ability for physicians to continue monitoring certain patients rather than immediately escalating to invasive diagnostic procedures.
A recent case example highlighted
by the company illustrates this point.
A high-risk patient with multiple small nodules categorized as Lung-RADS 3 received a CyPath® Lung result indicating “unlikely malignancy.” The physician continued surveillance imaging at six-month intervals consistent with Lung-RADS guidelines, and follow-up scans showed the nodules remained stable.
This type of scenario is not about dramatic outcomes.
It is
about clinical workflow.
And workflow solutions are the ones that can repeat across healthcare systems.
⚡ Catalysts (1)(2)(3)(4)(7)(8)
This is where the story begins to build momentum.
Instead of relying on a single future milestone, the company is layering several developments that could generate continued
updates.
1) A 2,000-Patient Longitudinal Trial
The company is preparing a 2,000-patient longitudinal clinical trial across up to 20 collection sites, including more than a dozen VA and military medical centers.
Enrollment is expected to begin in Q1 2026.
The study is designed to evaluate how CyPath® Lung may support risk
stratification, clinical decision-making, detection, and surveillance for pulmonary nodules.
Longitudinal trials of this scale can produce a steady stream of clinical data over time.
2) Clinical Leadership Expansion
bioAffinity Technologies, Inc. (Nasdaq: BIAF) recently added several nationally recognized pulmonary and lung cancer specialists to its Medical and Scientific Advisory Board,
including physicians affiliated with MD Anderson, NYU Langone, and the University of Wisconsin.
The company says these additions support its goal of advancing clinical implementation and broader adoption of CyPath® Lung.
When recognized clinicians attach themselves to a diagnostic platform, it can accelerate conversations within hospital systems and research networks.
3) Commercial Progress and VA System
Access
The company highlights 2025 milestones that include:
• 100% year-over-year growth in CyPath® Lung revenue and units sold
• Entry into major VA medical centers with lung nodule programs
• Expanded presence in strategic regional markets
This type of traction matters because diagnostics adoption is often driven by repeat physician usage within institutional
systems.
4) The Economic Argument
Healthcare systems increasingly weigh cost alongside clinical outcomes.
The company references a 2024 economic evaluation authored by pulmonologists that estimates potential savings if CyPath® Lung is incorporated into lung nodule management.
The analysis cites:
• $2,733 in potential savings per Medicare patient, representing
approximately $370 million annually
• $6,460 in potential savings per commercially insured patient, representing roughly $895 million annually
Economic arguments can broaden the list of decision makers involved in adoption discussions — from clinicians to hospital administrators and payers.
5) New Platform Research in Asthma and COPD (7)
The company recently presented new scientific research at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting in Philadelphia.
The research demonstrated that the company’s diagnostic platform could identify antibody drug receptors in sputum, including receptors for the asthma therapies dupilumab
and benralizumab.
According to the company, the work is part of an effort to develop diagnostics that could help physicians match asthma and COPD patients with the most effective therapies and monitor inflammatory changes over time. (7)
This research suggests the company’s technology platform may extend beyond lung cancer diagnostics into broader respiratory disease
applications.
6) New Validation Study with Brooke Army Medical Center (8)
In February, bioAffinity Technologies, Inc. (Nasdaq: BIAF) announced a validation study with Brooke Army Medical Center (BAMC).
The study will evaluate CyPath® Lung using sputum samples obtained through tracheal and bronchial suctioning, a method
that could expand sample collection options for the test.
The study is expected to enroll approximately 30–50 patients, with results anticipated by mid-year 2026. (8)
If validated, this approach could allow physicians to analyze sputum samples collected during bronchoscopy procedures, potentially expanding how CyPath® Lung fits into existing clinical
workflows.
Bronchoscopy itself is widely used in the United States, with roughly 500,000 procedures performed annually, and the related U.S. procedure market is estimated between $700 million and $920 million. (8)
⏱️ Why Timing Matters (1)(2)(3)(4)(5)(7)(8)
Stepping back, the company’s strategy appears focused on
building momentum across three areas that often drive attention.
Credibility
Clinical leadership additions and collaborations with institutions such as Brooke Army Medical Center.
Evidence scale
A planned 2,000-patient trial that could generate longitudinal clinical data.
Commercial traction
Growth in CyPath® Lung usage and expansion
into VA medical centers.
At the same time, the company is beginning to show how its diagnostic platform could extend beyond lung cancer into other respiratory diseases.
That combination — expanding evidence, growing clinical engagement, and broader platform potential — is what can gradually shift a diagnostic technology from a niche tool into a larger healthcare conversation.
✅ The
Checklist
Here are the key developments currently shaping the story:
Evidence expansion
2,000-patient trial preparing to begin enrollment in Q1 2026.
Clinical credibility
New pulmonary and lung cancer leaders added to the advisory board.
Commercial traction
100% year-over-year growth in CyPath® Lung revenue and units and expansion into VA medical
centers.
Platform expansion
AAAAI research demonstrating the platform’s ability to identify drug receptors for asthma therapies. (7)
New clinical validation study
Brooke Army Medical Center study evaluating deep suction sputum samples for CyPath® Lung. (8)
Economic rationale
Published cost-savings
estimates of $370M for Medicare and $895M for commercial populations.
That is a catalyst stack worth watching.
If the company continues executing on the timeline it has outlined, the next phase becomes straightforward:
More sites.
More data.
More clinical conversations.
More updates.
And when updates begin arriving consistently, attention often follows.
More soon.
To your
success,
Max Masters
Co-founder, Market Tips Newsletter
