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Form 8-K

sec.gov

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-049188

Filed: 2026-10-29

Period: 2026-10-29

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 29, 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))

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 ☒

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

October 29, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that it will join physicians, patients and other healthcare providers at the Lung Cancer Initiative of North Carolina’s Battle

of the Blues that will highlight advancements in new diagnostics and therapies that are improving the lives of patients with lung cancer.

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 October 29, 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 29, 2026

BIOAFFINITY

TECHNOLOGIES, INC.

By:

/s/ Maria

Zannes

Name:

Maria Zannes

Title:

President and Chief

Executive Officer

-3-

EX-99.1

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit

99.1

News

Release

bioAffinity

Technologies Highlights Importance of Link Between Early Lung Cancer Detection and Curative Treatment During National Lung Cancer Awareness

Month

Benefits

of CyPath® Lung to be shared with North Carolina patient advocacy and healthcare community at November 5 “Battle

of the Blues” Event

SAN

ANTONIO, Texas – October 29, 2026 – In recognition of National Lung Cancer Awareness Month, bioAffinity

Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for early lung cancer detection with its

noninvasive CyPath® Lung test, will join physicians, patients and other healthcare providers at the Lung Cancer Initiative

of North Carolina’s Battle of the Blues, an event that will highlight advancements in new diagnostics and therapies that

are improving the lives of patients with lung cancer.

The

Company will join others committed to advancing lung cancer awareness, research, and patient advocacy on November 5, 2026, at the event

where the results of major trials intended to change physician practice will be presented and providers

will learn of actionable thoracic oncology results that can enable them to improve treatment and care of lung cancer patients.

“During

National Lung Cancer Awareness Month, it is important to highlight the fact that lung cancer diagnosis and treatment is advancing at

a rapid pace. We are honored to be joining patient advocates and the dedicated physicians who play a crucial part in these advancements,”

said Maria Zannes, President and CEO of bioAffinity Technologies. “Early lung cancer detection can lead to curative therapy. Much

has changed – for the better – since my father died at age 39 of lung cancer. We are happy to be part of this good-news story.”

CyPath

Lung is a noninvasive, patent-protected assay that analyzes the lung microenvironment using advanced flow cytometry, AI-driven analysis,

and a proprietary combination of the fluorescent porphyrin TCPP and other biomarkers. The test characterizes cell populations in patient

sputum that indicate cancer may be present in the lung. CyPath Lung’s binary result of “Likely” or “Unlikely”

for malignancy gives physicians additional information to help assess lung cancer risk in patients with pulmonary nodules and guide decisions

about appropriate follow-up and care.

Using

CyPath Lung has the potential to diagnose lung cancer earlier when treatment is more effective. In multiple case studies, CyPath Lung

has detected lung cancer as early as curative Stage 1A. Decisions about follow-up and care should be based on the patient’s overall

clinical evaluation.

-1-

The

Lung Cancer Initiative of North Carolina’s Battle of the Blues brings together members of the lung cancer community to raise

awareness and support efforts to improve outcomes for people affected by lung cancer.

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, including changes to the event’s schedule or the Company’s participation; the possibility that results cited

in case studies may not be replicated in broader populations or routine clinical practice; and the fact that earlier cancer detection

does not necessarily lead to improved patient outcomes. Additional risks and uncertainties are described 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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