Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-047168

Filed: 2026-10-15

Period: 2026-10-15

CIK: 0001712762

SIC: 8731 (SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH)

Item: Other Events

Item: Financial Statements and Exhibits

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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): October 15, 2026

bioAffinity

Technologies, Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-41463

46-5211056

(State

or other jurisdiction

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))

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 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 ☒

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.

October 15, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that it will sponsor a Learning Theater presentation at CHEST 2026, the annual meeting of the American College of Chest Physicians, on

the evolving role of CyPath Lung® in improving lung cancer risk stratification and managing pulmonary nodules in patients at high

risk for lung cancer. The presentation will include discussion of the Company’s positive research data in the development of its

new test measuring asthma and COPD-related lung inflammation and drug-related receptors.

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 October 15, 2026

104

Cover Page Interactive

Data File (embedded within the XBRL document)

-2-

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: October 15, 2026

BIOAFFINITY

TECHNOLOGIES, INC.

By:

/s/ Maria

Zannes

Name:

Maria Zannes

Title:

President and Chief

Executive Officer

-3-

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

News

Release

bioAffinity

Technologies to Present New Perspectives on CyPath® Lung’s Use for Cancer Risk Assessment at CHEST 2026

Chief

Medical Officer Gordon Downie, MD, to host CHEST 2026 Learning Theater on clinical use of CyPath® Lung

Presentation

to address current challenges in pulmonary nodule management and to discuss preliminary research data from the ongoing development of

a new, investigational test for asthma and COPD

bioAffinity

Technologies’ Medical and Scientific Advisory Board to convene in conjunction with CHEST 2026

SAN

ANTONIO, Texas – October 15, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, will sponsor a Learning Theater presentation

at CHEST 2026, the annual meeting of the American College of Chest Physicians, on the evolving role of CyPath®

Lung in improving lung cancer risk stratification and managing pulmonary nodules in patients at high risk for lung cancer. The presentation

will include discussion of the Company’s positive research data in the development of its new test measuring asthma and COPD-related

lung inflammation and drug-related receptors.

bioAffinity

Technologies Chief Medical Officer Gordon H. Downie, MD, PhD, will address the challenges clinicians face as the growing number of newly

discovered and changing pulmonary nodules increases the difficulty of determining which nodules require intervention and which can be

safely monitored. Using clinical cases, the presentation will examine the limitations of predictive models and the potential role of

the lung microenvironment in improving lung cancer risk stratification.

“With

increased lung cancer screening rates, more incidental findings and AI’s ability to mine medical records, we are getting better

at finding pulmonary nodules. But that is just the first step,” Dr. Downie said. “By analyzing cells from the lung microenvironment,

CyPath Lung’s binary result – either likely or unlikely malignancy – provides new information that complements imaging,

clinical risk models and physician gestalt to help inform decisions about further testing, biopsy or continued surveillance.”

-1-

CyPath

Lung is a noninvasive sputum-based test that uses flow cytometry and an automated analysis pipeline developed using AI to evaluate cellular

characteristics associated with lung cancer. By analyzing cells collected directly from the lungs, the test provides important information

distinct from imaging and blood-based biomarkers. The noninvasive CyPath Lung test can be used on high-risk individuals without an identified

nodule and in patients with a prior cancer diagnosis. The Company’s test for asthma and COPD-related lung inflammation referenced

below is an investigational research program and is not available for clinical use.

CHEST

2026 Learning Theater

Title:

Lung Nodules, Lung Microenvironment, Predictive Models and Clinician Risk Stratification: Using CyPath® Lung Testing

for Early Diagnosis of Lung Cancer

Date: October 21, 2026

Time:

12:30-1:15 p.m. MST

Location: Learning Theater 4, Phoenix Convention Center, Phoenix, AZ

bioAffinity

Technologies Medical and Scientific Advisory Board to convene at CHEST 2026

conjunction with the conference, bioAffinity’s Medical and Scientific Advisory Board will meet to discuss the Company’s

scientific and clinical programs, including CyPath Lung’s expansion into the federal healthcare system, the ongoing large-scale,

longitudinal clinical study for CyPath Lung, and research and development to characterize lung inflammation in asthma and COPD patients,

which may lead to targeted therapies and precision medicine.

“Our

Medical and Scientific Advisory Board’s extensive experience in real-world pulmonary practice and lung health is directly aligned

with our corporate and clinical mission to improve outcomes for patients by detecting lung cancer and other lung diseases early when

treatment is most effective,” said Maria Zannes, bioAffinity Technologies President and CEO. “We are always grateful for

their expert perspectives that inform our research priorities and clinical applications.”

Current

members of the Medical and Scientific Advisory Board are David Hill, MD, Chair of the American Lung Association Board of Directors; David

Ost, MD, MPH, Department of Pulmonology, University of Texas MD Anderson Cancer Center; Daniel Sterman, MD, Director of Division of Pulmonary,

Critical Care, and Sleep Medicine, New York University Langone Medical Center, Sheila Habib, MD, Director of the Pulmonary Lung Nodule

Clinic and the Lung Cancer Screening Program at South Texas Veterans Health Care Systems, Audie L. Murphy Memorial Veterans Hospital;

J. Scott Ferguson, MD, Director of Bronchoscopy, University of Wisconsin School of Medicine and Public Health; Neil Alexis, PhD, Principal

Investigator at the University of North Carolina School of Medicine Center for Environmental Medicine, Asthma and Lung Biology; and Sandeep

Bansal, MD, Medical Director of Lung Innovations Network.

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 novel 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 may help inform physician decision-making when evaluating whether further

invasive procedures are warranted. CyPath Lung is marketed as a Laboratory Developed Test (LDT), is not intended for use as a sole diagnostic

tool, and should be considered alongside other clinical findings. For more information, visit www.cypathlung.com.

-2-

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. Forward-looking statements in this press release include, but are not limited to, statements regarding

the Company’s research and development of a new test for asthma and chronic obstructive pulmonary disease (COPD), the potential

clinical and commercial applications of CyPath Lung and such new test, the expansion of CyPath Lung into the federal healthcare system,

the ongoing longitudinal clinical study of CyPath Lung, and the Company’s research priorities and clinical applications, and 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

-3-

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