Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-045034

Filed: 2026-09-30

Period: 2026-09-30

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): September 30, 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.

September 30, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that it has delivered the first joint exhibition of CyPath® Lung under the Company’s recently announced distribution

agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business (SDVOSB), to more than 300 physicians, healthcare professionals

and VA leaders at the National Association of Veterans’ Research and Education Foundations (NAVREF) Annual Conference in Arlington,

Virginia.

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 September 30, 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:

September 30, 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 Promotes Veteran Awareness and Access to Its Noninvasive CyPath® Lung Cancer Test Through Distribution Partnership with

Veteran-Owned AvMEDICAL

Companies

debut federal distribution collaboration to VA leadership, administrators and physicians at NAVREF 2026

bioAffinity

engages GO2 for Lung Cancer network to broaden outreach to veterans at risk

SAN

ANTONIO, TEXAS — September 30, 2026 — bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, is taking significant steps toward

bringing its lung cancer test to the veterans who need it. This week, bioAffinity and its federal healthcare distribution partner AvMEDICAL,

a Service-Disabled Veteran-Owned Small Business (SDVOSB), delivered the first joint exhibition of CyPath® Lung under their

new distribution agreement to more than 300 physicians, healthcare professionals and VA leaders at the National Association of

Veterans’ Research and Education Foundations (NAVREF) Annual Conference in Arlington, Virginia.

The

companies’ nationwide federal healthcare distribution agreement is intended to expand government and agency access to CyPath Lung,

bioAffinity Technologies’ noninvasive test for lung cancer, via AvMEDICAL’s established procurement channels, government

contracting expertise and existing customer relationships.

“The

2026 NAVREF conference was the perfect venue to debut our distribution agreement with AvMEDICAL and share our companies’ commitment

to improving healthcare and quality of life for veterans,” said Maria Zannes, President and CEO of bioAffinity Technologies. “We

look forward to building on the significant interest in CyPath Lung and the many new connections we made with VA physicians and administrators

to actively expand veteran awareness and access across the federal healthcare market.”

bioAffinity

Technologies is a member of NAVREF’s Industry Partner Consortium, a collaborative platform to advance VA research.

Responding

to a significant health burden among veterans

Lung

cancer weighs heavily on the veteran community. The U.S. Department of Veterans Affairs (VA) reports that approximately 7,700 veterans

are diagnosed with lung cancer each year. AvMEDICAL’s federal healthcare distribution capabilities and its relationships with government

healthcare organizations are intended to support bioAffinity’s efforts to make it easier for veterans to access CyPath Lung for

earlier detection. The test is designed to complement imaging and other clinical assessments by giving physicians additional actionable

information from a noninvasive sputum sample.

Extending

outreach through the lung cancer screening community

bioAffinity

Technologies also presented CyPath Lung to healthcare leaders attending the GO2 for Lung Cancer Centers of Excellence Lung Cancer Screening

and Care Conference this week in San Diego, California. The conference covers the continuum of early detection, diagnosis, treatment,

and survivorship, and gives bioAffinity another opportunity to expand access to CyPath Lung for veterans and other patients at risk.

The

GO2 for Lung Cancer nonprofit organization partners with the VA to work collaboratively to increase awareness of the importance of lung

cancer screening for veterans, increase access to screening through its national network of more than 700 screening centers of excellence

and provide VA staff with resources for screening implementation, patient education and research programs.

About

AvMEDICAL

is a Service-Disabled Veteran-Owned Small Business (SDVOSB) that sources premium medical-surgical and laboratory supplies and equipment

from top-tier manufacturers to the government healthcare system. Since 2020, AvMEDICAL has more than doubled its product portfolio to

provide enhanced product offerings to its federal government customers. The portfolio covers key categories, including remote cardiac

monitoring, ultrasound, advanced bedside monitors, infusion systems, incontinence products for both hospital and home use, and best-in-class

laboratory and respiratory testing solutions.

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 may help inform physician decision-making when evaluating whether further

invasive procedures are warranted. 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. www.cypathlung.com

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 anticipated benefits of the distribution agreement and collaboration with AvMEDICAL, including expected expansion of government and

agency access to and adoption of CyPath Lung, and expectations regarding growth in demand for, or use of, CyPath Lung following the NAVREF

and GO2 for Lung Cancer conferences. Important factors that could cause actual results to differ materially from current expectations

include, among others, the risk that AvMEDICAL and bioAffinity Technologies are unable to realize the anticipated benefits of their distribution

agreement, including delays or failure in securing government contracts or procurement approvals; the Company’s ability to maintain

and expand adoption of CyPath Lung as a Laboratory Developed Test, including compliance with evolving CLIA; the Company’s need

for additional capital and ability to obtain financing on acceptable terms, or at all; competition from other diagnostic technologies

and companies; 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

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