Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-025338

Filed: 2026-05-27

Period: 2026-05-27

CIK: 0001712762

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): May 27, 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))

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 ☒

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.

May 27, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that it has received notification

of allowance from the Mexican Institute of Industrial Property for a patent application related to methods of predicting the likelihood

of lung cancer using flow cytometry.

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 May 27, 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:

May 27, 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

bioAffinity

Technologies Announces Notification of Mexico Patent Allowance Covering Novel Lung Cancer Detection Methods Using CyPath®

Lung Technology

Strong

intellectual property portfolio helps build shareholder value

Patent

strategy protects CyPath® Lung’s flow cytometry-driven diagnostic approach in international markets

SAN

ANTONIO, Texas – May 27, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

advancing early-stage cancer diagnostics including CyPath® Lung, the Company’s commercially available test

for early-stage lung cancer, today announced it has received notification of allowance from the Mexican Institute of Industrial Property

for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry.

Upon

issuance, the Mexican patent application will protect the use of defined antibodies and the porphyrin TCPP to label cell populations

in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum.

“This

patent expands our global intellectual property portfolio and protection of CyPath® Lung’s proprietary approach

to detecting lung cancer at its earliest and most treatable stages,” said Maria Zannes, President and CEO of bioAffinity Technologies.

“The integration of advanced cell biology, flow cytometry and AI into an easy-to-use, noninvasive test clearly differentiates our

technology, which is designed to support clinicians in evaluating indeterminate pulmonary nodules and high-risk patients.”

CyPath®

Lung uses flow cytometry and artificial intelligence with at-home sample collection to assess indeterminate pulmonary nodules in high-risk

patients. Physicians are adding CyPath® Lung to the clinical pathway to help risk stratify patients, reduce patient anxiety,

support surgical and treatment decision-making, and reduce overall healthcare costs.

The

patent further strengthens the Company’s intellectual property (IP) portfolio supporting its flow cytometry-based CyPath®

Lung diagnostic platform, which now includes multiple patents in the United States, the European Union, China, Japan, Australia, Canada

and Mexico. “Strong intellectual property protection for CyPath® Lung benefits

not only patients and their physicians, but also supports value creation for our shareholders,” Ms. Zannes said.

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.

-1-

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), 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 risk that pending patent applications may not result in issued patents, changes in the regulatory framework governing

Laboratory Developed Tests including potential increased FDA oversight, the Company’s ability to successfully commercialize CyPath®

Lung in domestic and international markets, the Company’s ability to realize value from its international intellectual property

portfolio, the sufficiency of the Company’s capital resources, 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

-2-

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