They are trying to win with credibility, scale, and a calendar that can keep producing fresh updates.
Today I want to walk you through the narrative bioAffinity Technologies, Inc. (Nasdaq: BIAF) is laying out across its deck and recent press releases.
No hype for hype’s sake. Just the setup, the catalyst stack, and the timing logic.
🌍 The
Market (1)(2)(3)(4)
Lung cancer is not a small market problem. It is a large, persistent, high cost reality.
The company highlights 2.48M new cases worldwide in 2022 and 1.8M deaths annually.
In the United States, (Nasdaq: BIAF) points to an estimate that 19.3M Americans should have annual lung cancer
screening.
Here is where it gets messy in real world care.
Screening and imaging often identify lung nodules that are not immediately clear. Those findings can lead to repeated follow up scans, anxiety, uncertainty, and sometimes invasive procedures.
The deck projects the number of indeterminate pulmonary nodules requiring follow up grows from 2.9M in 2025 to 4.7M in 2030, a 62%
increase.
That growth matters because it is not theoretical volume. It is a pipeline of patients that clinicians have to manage, systems have to pay for, and people have to live through.
It is also why bioAffinity Technologies, Inc. (Nasdaq: BIAF) keeps anchoring its story in the “in between” zone, the place where nodules are found but the next step is not always obvious.
And yes, the money around this
problem is already big.
The company cites a lung cancer diagnostics market estimated at $20B in 2023 and projected to reach $38B by 2034.
Large spend. Growing volume. A real clinical need.
That is a market backdrop where a test that fits workflow can gain traction, and where traction can turn into attention.
🔬 The Company (1)(2)(3)(4)
The core commercial focus is CyPath Lung.
The company describes it as a noninvasive test that uses flow cytometry plus proprietary artificial intelligence to analyze sputum for cell populations that indicate malignancy.
In the deck, the company highlights practical elements that matter for scaling use,
including at home sample collection and results 3 days after the sample arrives at the lab.
Now let’s get to the numbers the market tends to latch onto once a story starts drawing attention.
The company cites clinical study results showing:
92% sensitivity
87% specificity
88% accuracy
99% negative predictive value
in people
at high risk with small indeterminate pulmonary nodules under 20 millimeters.
That 99% negative predictive value is not just a stat. It is a positioning tool.
It supports the idea that a negative result can reinforce surveillance decisions for certain patients, rather than immediately escalating to more invasive pathways.
The company’s recent case study is designed to make that point feel
concrete.
A high risk patient with heavy smoking history had multiple small nodules categorized as Lung Rads 3. The pulmonologist ordered CyPath Lung, the result returned “unlikely malignancy,” and the patient continued serial six month CT surveillance consistent with Lung Rads 3 recommendations. Follow up imaging showed the nodules remained stable.
That kind of case is not a “miracle story.”
It is a workflow
story.
And workflow stories are the ones that can repeat across clinics.
This is also where bioAffinity Technologies, Inc. (Nasdaq: BIAF) is trying to push the conversation toward standard of care alignment for indeterminate pulmonary nodules.
⚡ Catalysts (1)(2)(3)(4)
This is the part that matters most for momentum driven
readers.
Not one distant milestone.
A stack of near term and ongoing triggers that can keep the narrative alive and keep new eyes coming in.
✅ 1) Large longitudinal trial beginning enrollment in Q1 2026
The company states a 2,000 patient longitudinal clinical trial with up to 20 collection sites is ready, including more than a dozen VA and military medical
centers, with patient enrollment set to begin in Q1 2026.
The stated purpose is practical, not academic.
The trial is designed to support inclusion of CyPath Lung as part of standard of care for pulmonary nodules and to evaluate performance for risk stratification, clinical decision making, detection, and survivor surveillance.
That kind of real world longitudinal structure can create a steady flow of updates
over time.
And steady flows are how stories stay in rotation.
✅ 2) Clinical leadership being added around the platform
bioAffinity Technologies, Inc. (Nasdaq: BIAF) announced new appointments to its Medical and Scientific Advisory Board, adding nationally recognized pulmonary and lung cancer authorities, including David Ost at MD Anderson, Daniel Sterman at NYU Langone, and J Scott Ferguson at the
University of Wisconsin.
The company frames this expansion as aligning clinical, scientific, and commercial priorities, including integrating CyPath Lung into standard of care for indeterminate pulmonary nodules.
The CEO also emphasizes a focus on clinical implementation and broader adoption.
When recognized names attach themselves to a program like this, it tends to accelerate clinical conversations and unlock access points that are hard
to reach without that credibility.
✅ 3) VA channel presence and commercial traction
The deck highlights 2025 milestones that include a 100% increase in CyPath Lung year over year revenue and units sold, entry into major VA medical centers with lung nodule programs, and expanded field presence in strategic regional markets.
That is the combo that often matters most.
Not just a
product story.
A usage story.
A repeat ordering story.
And it is being tied to institutional style settings where volume can scale.
✅ 4) The economics argument
Healthcare systems care about outcomes, but they also care about cost.
bioAffinity Technologies, Inc. (Nasdaq: BIAF) references a 2024 economic evaluation authored by pulmonologists, highlighting potential savings if CyPath Lung is
added to standard of care.
They cite $2,733 per Medicare patient with estimated annual savings of about $370M.
They also cite $6,460 per commercially insured patient with estimated annual savings of about $895M.
This matters because the economics narrative can widen the decision maker list.
It becomes a conversation that can include
clinicians, administrators, and pay related stakeholders, not just the clinical champion.
More stakeholders means more pathways for adoption discussions to move forward.
✅ 5) Platform framing beyond one product
The deck frames CyPath Lung as the first commercial test in a pipeline that includes development work around asthma and COPD, while pointing to the size of those therapeutic markets.
Markets often
reward platform narratives only after the first product starts showing real traction.
The company is clearly trying to lay that groundwork while commercializing CyPath Lung.
⏱️ Why Now (1)(2)(3)(4)(5)
Here is the simplest way to describe why timing matters here.
bioAffinity Technologies, Inc. (Nasdaq: BIAF) is building repetition across the three
things that tend to drive attention.
Credibility.
Evidence scale.
Commercial traction.
They’re adding recognizable clinical leadership.
They’re preparing a 2,000 patient longitudinal trial with enrollment set to begin in Q1 2026.
They’re highlighting a 2025 commercial step up with 100% year over year revenue and unit growth and entry into major VA medical centers.
That is a pattern where attention can build, rather than
spike and vanish.
One more point that anchors the urgency of the clinical problem.
The company notes that most lung cancer patients are diagnosed at later stages and cites that in 2025 less than 30% of patients survived 5 years.
That is why earlier detection and better risk stratification remain high value conversations.
If you want the clean checklist I am tracking from the company’s own materials,
it is this:
Scale evidence
2,000 patient trial beginning enrollment Q1 2026 across up to 20 sites, including many VA and military centers.
Clinical credibility
High profile pulmonary and lung cancer leaders added to the advisory board.
Commercial traction
2025 milestones including 100% year over year revenue and unit growth and entry into major VA medical
centers.
Economic angle
Published savings math cited at $370M for Medicare and $895M for commercially insured populations.
That is a real catalyst stack.
And stacks are what keep a story alive long enough for the market to care.
If this narrative continues to progress the way bioAffinity Technologies, Inc. (Nasdaq: BIAF) is laying it out, the next phase is simple.
More
sites.
More data.
More adoption conversations.
More updates.
And once updates become consistent, attention tends to become consistent too.
More soon,
Max Masters
Co-founder, Market Tips Newsletter
