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Veteran lung health webinar from bioAffinity (BIAF) spotlights CyPath® Lung

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

bioAffinity Technologies filed an update describing an educational webinar on July 21, 2026, focused on lung health screening and early detection for U.S. veterans at increased risk for lung cancer and other respiratory diseases. The session will cover imaging, noninvasive diagnostics and access to screening and follow-up care.

The webinar is hosted by NAVREF and will feature experts from Philips, bioAffinity Technologies and 4DMedical. Speakers will discuss mobile CT screening, CyPath® Lung testing and advanced functional lung imaging as approaches that may help support earlier detection and clinical decision-making in veteran populations.

The filing also highlights CyPath® Lung, a noninvasive sputum-based test for high-risk patients, which in a published clinical trial showed 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value for detecting lung cancer in patients with small indeterminate nodules.

Positive

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Negative

  • None.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Webinar date July 21, 2026 Veteran lung health webinar event date
Webinar time ET 6 p.m. ET Scheduled webinar time for U.S. East Coast
CyPath Lung sensitivity 92% Sensitivity in published clinical trial of high-risk patients
CyPath Lung specificity 87% Specificity in published clinical trial of high-risk patients
CyPath Lung accuracy 88% Overall accuracy in published clinical trial
CyPath Lung NPV 99% Negative predictive value in published clinical trial
CyPath® Lung medical
"CyPath® Lung, the Company’s commercially available test for early-stage lung cancer"
Laboratory Developed Test regulatory
"CyPath® Lung is marketed as a Laboratory Developed Test (LDT)"
A laboratory developed test is a medical diagnostic created, validated and performed within a single clinical laboratory rather than sold as a boxed product to other labs or clinics. For investors, LDTs can offer faster product rollout and niche revenue streams like a custom service, but they also carry regulatory and reimbursement uncertainty and competitive risk—think of them as a handmade tool that can be quickly offered to customers but may face shifting rules or market limits.
Clinical Laboratory Improvement Amendments regulatory
"LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA)"
negative predictive value medical
"demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV)"
Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.
forward-looking statements regulatory
"Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): June 16, 2026

 

bioAffinity Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-41463   46-5211056

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification Number)

 

3300 Nacogdoches Road, Suite 216

San Antonio, Texas 78217

(Address of principal executive offices, including zip code)

 

(210) 698-5334

(Registrant’s telephone number, including area code)

 

 

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Title of each class   Trading Symbols   Name of each exchange on which registered

Common Stock, par value $0.007 per share

 

 

 

BIAF

 

 

The Nasdaq Stock Market LLC

(Nasdaq Capital Market)

         
Warrants to purchase Common Stock   BIAFW  

The Nasdaq Stock Market LLC

(Nasdaq Capital Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by checkmark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 8.01. Other Events.

 

On June 16, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing a webinar on July 21, 2026, featuring clinical experts discussing emerging approaches to lung health screening and early detection for veterans at increased risk for lung cancer and other respiratory diseases.

 

A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit
Number
  Description
99.1   Press Release issued by bioAffinity Technologies, Inc., dated June 16, 2026
104   Cover Page Interactive Data File (embedded within the XBRL document)

 

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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 16, 2026 BIOAFFINITY TECHNOLOGIES, INC.
   
  By: /s/ Maria Zannes
  Name: Maria Zannes
  Title: President and Chief Executive Officer

 

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Exhibit 99.1

 

 

 

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

 

Expert panel will share real-world case studies to demonstrate how mobile CT screening, noninvasive CyPath® Lung testing, and comprehensive functional lung imaging can reduce cost while improving access, early detection and outcomes for veterans

 

National Association of Veterans’ Research and Education Foundations (NAVREF) to host July 21 webinar

 

Register here

 

SAN ANTONIO, Texas – June 16, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing cancer diagnostics including CyPath® Lung, the Company’s commercially available test for early-stage lung cancer, announced a webinar on July 21, 2026, featuring clinical experts discussing emerging approaches to lung health screening and early detection for veterans at increased risk for lung cancer and other respiratory diseases.

 

The educational webinar will explore current challenges in identifying and managing lung disease in veteran populations, including those potentially impacted by toxic exposures recognized under the PACT Act. Presenters will discuss advances in diagnostic technologies, imaging capabilities, and strategies that may support earlier detection and improved clinical decision-making.

 

The webinar will feature clinical perspectives on:

 

Lung cancer risk among veterans and the importance of early detection
The evolving role of imaging in lung health assessment
Emerging noninvasive diagnostic approaches
Opportunities to improve patient access to screening and follow-up care
Considerations for implementing comprehensive lung health programs

 

Speakers:

 

Moderator

 

Rashi Romanoff, Chief Executive Officer, National Association of Veterans’ Research and Education Foundations (NAVREF) NAVREF is a nonprofit organization that supports the research and education mission of the Department of Veterans Affairs by advancing innovation, fostering public-private partnerships, and accelerating the development of new healthcare solutions for veterans. NAVREF serves as a bridge between VA researchers, industry, academia, and philanthropic organizations to help bring promising technologies and clinical advancements to the veteran community.

 

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Panelists

 

Amy Rohs, MD, is a board-certified physician in Internal Medicine, Pulmonary Medicine, and Critical Care Medicine with more than 20 years of clinical experience and over a decade of leadership in tele-critical care, virtual health, and healthcare innovation. A former VA clinical and operational leader and current Physician Clinical Champion with Philips, she combines extensive experience in critical care, telemedicine, and military medicine to advance scalable, technology-enabled models of care.

 

Philips is a health technology company focused on improving people’s lives through meaningful innovation – from healthy living and prevention to diagnosis, treatment and home care. Applying advanced technologies and deep clinical and consumer insights, Philips partners with customers to deliver integrated solutions that help provide improved patient experience, better health outcomes, improved staff experience, and lower cost of care.

 

Michael Nicholson, DO, will discuss his clinical experience using CyPath® Lung, bioAffinity Technologies’ noninvasive test for early detection of lung cancer. He is a pulmonary, critical care, advanced lung disease, and lung transplantation specialist whose clinical focus includes improving noninvasive malignancy risk stratification for patients with pulmonary nodules. Dr. Nicholson has published peer-reviewed research, presented at international conferences, and authored textbook chapters on topics including bronchoscopic lung volume reduction, COPD, alpha-1 antitrypsin deficiency, interstitial lung disease, pulmonary hypertension, lung transplantation, and pleural disease.

 

Dr. Nicholson practices at RWJBarnabas Health, New Jersey’s largest and most comprehensive academic health system, providing integrated care, medical education, and research across a statewide network of hospitals, ambulatory centers, and specialty practices. CyPath® Lung is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy.

 

Greg Mogel, MD, 4DMedical’s Chief Medical Officer, is a practicing radiologist and physician executive with a long career in medicine and engineering in government, academia, and industry. He previously held multiple leadership roles at Kaiser Permanente where he played a central role in the establishment of Lung Cancer Screening across the largest integrated healthcare delivery system in the United States. A proud veteran, Greg served in the United States Army Medical Corps.

 

4DMedical Limited is a medical technology company that develops advanced imaging and analysis solutions to assess lung structure and function. Its proprietary platform provides clinicians with highly detailed, noninvasive visualization of lung motion and airflow, enabling earlier detection of respiratory diseases and improved patient management.

 

Event Details:

 

Date: July 21, 2026

Time: 6 p.m. ET/5:00 p.m. CT (US and Canada)

 

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Veterans experience a higher incidence of lung cancer than the general population, underscoring the importance of timely screening and diagnostic evaluation. The webinar will provide healthcare professionals with insights into current clinical practices and emerging technologies that may help support improved outcomes for at-risk patients.

 

The program is intended for healthcare professionals involved in pulmonary medicine, oncology, radiology, primary care, veteran health services, and related specialties. For additional information or to register, please click this link.

 

About CyPath® Lung

 

CyPath® Lung by bioAffinity Technologies is a noninvasive test designed to improve the early detection of lung cancer in patients at high risk for the disease. CyPath® Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. In a published clinical trial of high-risk patients, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value (NPV) in detecting lung cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. The high NPV gives physicians greater confidence that a negative result is truly negative, potentially sparing patients from unnecessary invasive and costly procedures. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) and is not intended for use as a sole diagnostic tool and should be considered alongside other clinical findings.

 

About bioAffinity Technologies, Inc.

 

bioAffinity Technologies, Inc. addresses the need for noninvasive diagnosis of early-stage cancer and other diseases of the lung and broad-spectrum cancer treatments. The Company’s first product, CyPath® Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath® Lung is marketed as a Laboratory Developed Test (LDT) by Precision Pathology Laboratory Services, a subsidiary of bioAffinity Technologies. LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), which are administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.

 

Forward-Looking Statements

 

Certain statements in this press release 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 SEC, 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 this press release are cautioned not to place undue reliance on any forward-looking statements. The information in this release is provided only as of the date of this release, and the Company does not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may be required by applicable securities laws.

 

Contact

 

bioAffinity Technologies

Julie Anne Overton

Director of Communications

investors@bioaffinitytech.com

 

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FAQ

What did bioAffinity Technologies (BIAF) disclose in this 8-K filing?

bioAffinity Technologies disclosed an upcoming veteran-focused lung health webinar and provided details about CyPath® Lung. The event highlights imaging, noninvasive diagnostics, and clinical strategies for earlier detection of lung cancer and respiratory disease in at-risk veteran populations.

When is bioAffinity Technologies’ veteran lung health webinar scheduled?

The webinar is scheduled for July 21, 2026, at 6 p.m. ET/5 p.m. CT. It will feature clinical experts discussing lung cancer risk in veterans, screening challenges, emerging diagnostic tools, and strategies to improve access to early detection and follow-up care.

What is CyPath® Lung as described by bioAffinity Technologies (BIAF)?

CyPath® Lung is a noninvasive test intended to improve early detection of lung cancer in high-risk patients. It uses advanced flow cytometry and proprietary AI on sputum samples to identify cell populations indicating malignancy, and is marketed as a Laboratory Developed Test under CLIA oversight.

How did CyPath® Lung perform in the published clinical trial mentioned?

In a published clinical trial of high-risk patients with small indeterminate lung nodules under 20 millimeters, CyPath® Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and a 99% negative predictive value, supporting confidence that a negative result is truly negative in that setting.

Who are the main organizations involved in the bioAffinity veteran lung health webinar?

The webinar will be hosted by NAVREF and feature experts associated with Philips, bioAffinity Technologies and 4DMedical. These organizations bring perspectives on mobile CT screening, noninvasive CyPath® Lung testing, and advanced functional lung imaging for veteran lung health programs.

What audience is the bioAffinity Technologies webinar designed for?

The program is intended for healthcare professionals involved in pulmonary medicine, oncology, radiology, primary care, veteran health services and related specialties. It aims to provide practical insights on current practices and emerging technologies for managing lung disease risk in veteran populations.

Filing Exhibits & Attachments

7 documents