Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-046266

Filed: 2026-10-08

Period: 2026-10-08

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 8, 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 8, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that the Japan Patent Office has issued a Notice of Allowance, indicating its intention to grant a patent to the Company for the method

of predicting the likelihood of lung cancer powered by the CyPath® Lung test for early-stage lung cancer.

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 8, 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 8, 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 Announces Notification of Japanese Patent Allowance Covering Noninvasive CyPath® Lung and AI-Built Algorithm

Company’s

expanding intellectual property portfolio strengthens protection for its early lung cancer diagnostic in Asia

Patent

strategy protects proprietary CyPath Lung flow cytometry+AI approach in international markets

SAN

ANTONIO, Texas – October 8, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

focused on the need for noninvasive tests for the detection of early-stage lung cancer and other lung diseases, today announced that

the Japan Patent Office has issued a Notice of Allowance indicating its intention to grant a patent to bioAffinity Technologies for the

method of predicting the likelihood of lung cancer powered by the CyPath® Lung test for early-stage lung cancer.

The

Japanese patent application, titled “Detection

of Early-Stage Lung Cancer in Sputum Using Automated Flow Cytometry and Machine Learning,” will

be an important addition to bioAffinity Technologies’ patent portfolio, which includes 22 awarded U.S. and foreign patents and

36 pending patent applications related to its diagnostic platform and cancer treatment therapeutics. The Japanese patent will be the

first awarded in that country for CyPath Lung driven by an AI-built algorithm and the fifth patent protecting the Company’s early

lung cancer test awarded in Asia, including China and Hong Kong.

“The

Japanese patent for the CyPath Lung test strengthens and expands the Company’s intellectual property protection in the Asian market

by protecting our innovative, noninvasive test for early-stage lung cancer. We anticipate patents in additional geographic regions will

follow,” bioAffinity Technologies President and CEO Maria Zannes said. “Lung cancer is the deadliest cancer worldwide. We

believe CyPath Lung has the potential to improve the outcome for lung cancer patients around the globe through earlier detection when

treatment options are better. Strong intellectual property protection for the CyPath Lung test benefits not only patients and their physicians,

but also our shareholders and our Company. Our scientific team continues research and development on diagnostics that will open new markets

for bioAffinity Technologies.”

The

CyPath Lung test uses flow cytometry and artificial intelligence with at-home sample collection to assess indeterminate pulmonary nodules

in patients at high risk for lung cancer. Physicians are adding CyPath Lung to the clinical pathway to help risk stratify patients, reduce

patient anxiety, support surgical and treatment decisions, and reduce overall healthcare costs. Issuance of the patent is expected to

result after payment of the applicable issuance fee.

-1-

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

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 issuance of the Japanese patent and its timing and scope, assurance that the patent will provide the scope of protection

currently anticipated, the Company’s ability to obtain additional patents in other geographic regions, the strength, value and

enforceability of the Company’s intellectual property portfolio, the clinical and commercial potential and adoption of CyPath Lung,

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

-2-

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