8-K: bioAffinity Technologies: Q2 2026 Newsletter Highlights Growth

bioAffinity Technologies reports significant sales growth for its CyPath Lung test, announces a collaboration with Philips for veteran lung screening, and details progress in its companion diagnostics and skin cancer research.

Summary

• bioAffinity Technologies released its first quarterly newsletter for Q2 2026, detailing recent achievements and future developments.
• Sales of the noninvasive CyPath Lung test showed substantial growth, with unit sales in April increasing by nearly 300% compared to April 2025.
• The number of physician offices and clinics ordering CyPath Lung grew by 69% from Q1 2025 to Q1 2026, indicating expanding adoption.
• A new collaboration with Philips aims to enhance lung cancer screening for U.S. veterans using mobile CT scanning, CyPath Lung testing, and 4DMedical's imaging software.
• The company is developing companion diagnostics for the asthma and COPD market, with a pilot study underway at Brooke Army Medical Center (BAMC).
• Preclinical research shows potential for a topical treatment for basal and squamous cell carcinomas, common types of skin cancer, using proprietary siRNAs.
• The newsletter highlights various resources for physicians and patients, including webinars, podcasts, and case studies on the CyPath Lung test.

Sentiment

Score: 7

Explanation: StockSavvy.ai views this as a positive filing, highlighting strong sales momentum for its core product, strategic partnerships, and promising R&D advancements, indicating a company on a growth trajectory.

Positives

• CyPath Lung unit sales in April 2026 increased by nearly 300% compared to April 2025.
• The number of ordering physician offices and clinics for CyPath Lung increased by 69% from Q1 2025 to Q1 2026.
• Partnership with Philips to enhance lung cancer screening for U.S. veterans.
• Development of companion diagnostics for the multi-billion dollar asthma and COPD market.
• Positive preclinical research findings supporting a potential topical treatment for basal and squamous cell carcinomas.
• Mexico patent allowance covering novel lung cancer detection methods using CyPath Lung technology.

Negatives

• The filing does not explicitly mention any negative financial results or setbacks.
• Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from expectations.

Risks

• Risks related to the regulatory environment for laboratory developed tests.
• The company's ability to successfully commercialize CyPath Lung.
• Uncertainties associated with the development and commercialization of companion diagnostics for asthma and COPD.
• Challenges in translating preclinical research findings for skin cancer treatments into viable products.
• Reliance on third-party collaborations, such as with Philips and 4DMedical.

Future Outlook

The company expresses optimism about continued growth in CyPath Lung sales and the expansion of its product pipeline, including companion diagnostics for asthma and COPD, and potential topical treatments for skin cancer. The collaboration with Philips for veteran lung screening is also a key future initiative.

Management Comments

• "This is the first of our new Quarterly Newsletter series that will report on the achievements of our team at bioAffinity Technologies who are bringing to market products that can give people longer, healthier lives."
• "Sales continue to climb for our noninvasive CyPath Lung test that offers clarity when diagnosing lung cancer, allowing physicians to find and treat this deadly cancer at its earliest, curative stage."
• "We are proud to announce our collaboration with Philips on a program to enhance lung cancer screening for U.S. veterans."
• "Our pipeline of products includes companion diagnostics for the multi-billion-dollar asthma and COPD market."
• "And we recently announced positive news about our research findings that support our work to develop topical treatments for the most common of all types of cancer, basal and squamous cell carcinomas."
• "As you will read below, we have achieved a great deal and have the momentum to achieve much more. Stay tuned."

Industry Context

StockSavvy.ai notes that bioAffinity Technologies is operating in the highly competitive and rapidly evolving diagnostics and therapeutics market. The company's focus on early cancer detection (lung and skin) and chronic respiratory diseases (asthma, COPD) aligns with significant unmet medical needs and growing market opportunities. The collaboration with Philips, a major player in healthcare technology, suggests a strategic move to leverage established channels and expertise for broader market penetration, particularly within the veteran population.

Comparison to Industry Standards

• The reported 300% increase in CyPath Lung unit sales in April 2026 compared to April 2025 significantly outpaces typical growth rates for diagnostic tests in their early adoption phases, suggesting strong market reception or a low base in the prior year.
• The 69% increase in ordering physician offices and clinics indicates a robust expansion of the sales channel, which is a critical benchmark for diagnostic companies seeking widespread clinical integration.
• The company's focus on companion diagnostics for asthma and COPD targets a market valued in the billions, positioning it alongside other major diagnostic and pharmaceutical companies developing precision medicine solutions for these conditions.
• The development of topical treatments for basal and squamous cell carcinomas addresses a significant portion of the skin cancer market, where companies like Regeneron Pharmaceuticals and Bristol Myers Squibb have established presences with other cancer therapies.

Stakeholder Impact

• Shareholders: Potential for increased company valuation due to sales growth and pipeline development.
• Physicians: Access to new diagnostic tools (CyPath Lung) and information resources (CyPath Lung Connect) to improve patient care.
• Patients: Improved early detection of lung cancer, potential for less invasive diagnostic procedures, and development of new treatments for skin cancer and respiratory diseases.
• U.S. Veterans: Enhanced lung cancer screening programs through collaboration with Philips.
• Researchers/Medical Community: Contribution to advancements in lung cancer diagnosis, asthma/COPD management, and skin cancer treatment.

Next Steps

• Continue to expand CyPath Lung adoption through physician education and sales team efforts.
• Advance the pilot study with Brooke Army Medical Center for asthma and COPD companion diagnostics.
• Further research and development for topical skin cancer treatments.
• Participate in the July 21, 2026 webinar with Philips and 4DMedical to discuss enhanced lung cancer screening for veterans.

Key Dates

Recommendation

The filing shows positive momentum in sales and product development, particularly with the CyPath Lung test and strategic partnerships. However, it is a newsletter update and not a comprehensive financial report. While promising, the forward-looking nature of much of the content and the inherent risks in the biotech sector warrant a 'hold' recommendation pending more detailed financial disclosures and clinical validation of pipeline products.

Keywords

bioAffinity Technologies, CyPath Lung, lung cancer screening, companion diagnostics, asthma, COPD, skin cancer, Philips, veterans health, 8-K, newsletter