CyPath Lung sales surge as bioAffinity (NASDAQ: BIAF) expands pipeline
Rhea-AI Filing Summary
bioAffinity Technologies, Inc. filed an 8-K to share a company newsletter outlining commercial and R&D progress. The newsletter highlights that CyPath® Lung unit sales in April 2026 increased nearly 300% compared to April 2025, while the number of physician offices and clinics ordering the test rose 69% from first quarter 2025 to the same period in 2026.
The company is partnering with Philips and 4DMedical to enhance lung cancer screening for U.S. veterans using mobile CT scanning, CyPath Lung testing and advanced imaging, with a webinar hosted by NAVREF on July 21, 2026. It also discusses a pilot study with Brooke Army Medical Center for asthma and COPD companion diagnostics and preclinical research on proprietary siRNAs as potential topical treatments for common skin cancers.
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8-K Event Classification
Key Figures
Key Terms
laboratory developed tests regulatory
companion diagnostics medical
flow cytometry+AI technical
siRNAs medical
topical treatment medical
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Item 8.01. Other Events.
On June 30, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), released a newsletter providing an overview of certain recent developments. A copy of the newsletter is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Forward-Looking Statements
Certain statements in the newsletter constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. These forward-looking statements are subject to various risks and uncertainties, many of which are difficult to predict, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from current expectations include, among others, the Company’s ability to successfully commercialize CyPath® Lung, risks related to the regulatory environment for laboratory developed tests, and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and its subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Forms 10-Q and 8-K. Such forward-looking statements are based on facts and conditions as they exist at the time such statements are made and predictions as to future facts and conditions. While the Company believes these forward-looking statements are reasonable, readers of the newsletter are cautioned not to place undue reliance on any forward-looking statements. The information in the newsletter are provided only as of the date of the newsletter, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in the newsletter, except as may be required by applicable securities laws.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit Number |
Description | |
| 99.1 | Company Newsletter, 1st Edition, 2nd Quarter 2026, released by bioAffinity Technologies, Inc. on June 30, 2026 | |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: June 30, 2026 | BIOAFFINITY TECHNOLOGIES, INC. | |
| By: | /s/ Maria Zannes | |
| Name: | Maria Zannes | |
| Title: | President and Chief Executive Officer | |
Exhibit 99.1
Company Newsletter, 1st Edition
2nd Quarter 2026
Nasdaq: BIAF
See what’s happening at bioAffinity Technologies…
Message from our CEO
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. There is much to report. 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.
Sincerely,
Maria Zannes
President and CEO
Sales Accelerate for our Noninvasive CyPath® Lung
CyPath® Lung unit sales in April increased nearly 300% compared to April 2025. The number of physician offices and clinics ordering CyPath® Lung increased 69% from first quarter 2025 to the same period in 2026. We saw continued accelerated growth in the second quarter as more and more physicians learn from their peers and our sales team about CyPath® Lung.
Our success is a result of solid team execution on key growth strategies including the expansion of ordering physician sites, increasing peer-to-peer education among pulmonologists, family practices, and oncologists, and integrating CyPath® Lung into the clinical workflows for lung cancer risk assessment and nodule management.
Partnering with Philips to Advance Lung Cancer Screening
We’re partnering with Philips to enhance screening programs for U.S. Veterans at risk for lung diseases, including cancer, using mobile CT scanning, CyPath® Lung testing and 4DMedical’s advanced imaging software.
To learn more, register here for a webinar on July 21 at 6:00 pm ET, hosted by the National Association of Veterans Research and Education Foundations (NAVREF). The webinar will highlight how Philips, 4DMedical, and bioAffinity Technologies are working together to detect lung cancer at its earliest stages when it is most treatable, provide diagnostic insight into other lung diseases and risk-stratify veterans at increased risk for lung disease including cancer, many of whom are eligible under the PACT Act.
Hear, Watch and Read Why Physicians Use CyPath® Lung and Why Patients Praise It
The upcoming webinar is one of many you can find on CyPath® Lung Connect that provides easy access to recent webinars and podcasts where patients and physicians tell their stories about how CyPath® Lung has made a positive impact on their lives and their practices, respectively. Our podcasts are available on Apple, Spotify, or your favorite podcast channel. And be sure to check out our YouTube channel @CyPathLungConnect.
You’ll find particularly moving videos in which a patient tells how CyPath® Lung testing and her patient coach brought peace of mind after learning she had a pulmonary nodule. Her CyPath® Lung test resulted as unlikely malignancy. “It was a lifesaver. I want to shout it from the rafters,” she told us, and after watching, you’ll understand why.
Rather read than watch or listen? Visit CyPathLung.com to review more than a dozen case studies written by physicians demonstrating the real-world use of CyPath® Lung. Patient outcomes range from detecting lung cancer as early as Stage 1A when other adjuvant tools failed to find it to sparing patients with significant comorbidities from risky invasive procedures.
Introducing CyPath® Lung Connect, a platform featuring expert perspectives on lung cancer screening, early diagnosis and emerging technologies, as well as patient stories about their diagnostic journey.
Recent Webinars
Navigating Lower Cancer-Risk Nodules in High-Risk Patients with Noninvasive CyPath® Lung Testing
June 16, 2026
CyPath® Lung in Practice: A Physician Roundtable
April 8, 2026
Recent Podcasts
Enhancing Clinical Confidence: Managing Small Pulmonary Nodules with CyPath® Lung
June 2, 2026
CyPath® Lung in Clinical Practice: Pulmonologists Roundtable
June 10, 2026
Recent Patient Videos
A Patient’s Journey with CyPath® Lung
June 30, 2026
Working with Your Patient Coach: A Patient’s View
June 30, 2026
Our Project Pipeline
Advancing Research and Development for Companion Diagnostics for Asthma and Chronic Obstructive Pulmonary Disease (COPD)
A pilot study with Brooke Army Medical Center (BAMC) is underway to evaluate bioAffinity’s proprietary tests under development that seek to quantify the type of inflammation in the lung to help determine what drugs might work best for asthma and COPD patients. The research collaboration with BAMC leverages our proprietary flow cytometry+AI technology to develop precision diagnostics for common airway diseases that can be treated effectively with new and emerging therapeutics.
Topical Therapeutics for Skin Cancer
bioAffinity recently shared preclinical research demonstrating that silencing specific cell surface receptors using our proprietary siRNAs selectively kills squamous skin cancer cells or impairs their proliferation while leaving normal skin cells unaffected. The findings suggest a potential topical treatment for common skin cancers - basal cell carcinoma ranks number one, followed by squamous cell carcinoma at number two. Together, they outpace all other cancers combined.
Get Caught Up on Our Recent News
Jun 16, 2026
bioAffinity Technologies Announces Program to Advance Veteran Lung Health: Philips, bioAffinity Technologies and 4DMedical Highlight New Approaches to Lung Health Screening for U.S. Veterans
Jun 2, 2026
Multidisciplinary Physician Panel to Share Real-World Benefits of bioAffinity Technologies’ Noninvasive CyPath Lung® Cancer Test in Upcoming Society for Advanced Bronchoscopy Webinar
May 27, 2026
bioAffinity Technologies Announces Notification of Mexico Patent Allowance Covering Novel Lung Cancer Detection Methods Using CyPath® Lung Technology
May 12, 2026
bioAffinity Technologies Reports Record Monthly CyPath® Lung Unit Sales and Significant Year-Over-Year Growth in April 2026
May 8, 2026
bioAffinity Technologies Reports First Quarter 2026 Results and Expanding Adoption and Clinical Usage of CyPath® Lung
Connect with bioAffinity Technologies
bioaffinitytech.com
cypathlung.com
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