Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-034711

Filed: 2026-07-27

Period: 2026-07-27

CIK: 0001712762

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

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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): July 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.

July 27, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

the publication of a comprehensive clinical review and white paper authored by the Company’s Chief Medical Officer, Gordon H. Downie,

MD, PhD, that presents a practical clinical framework for incorporating CyPath® Lung into pulmonary nodule evaluation

and cancer surveillance.

copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

of July 24, 2026, there were 7,783,061 outstanding shares of the Company’s common stock and the aggregate market value of the Company’s

common stock was approximately $5.1 million based on the closing price of a share of the Company’s common stock on that date, as

reported by the Nasdaq Capital Market.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

Number

Description

99.1

Press Release issued by bioAffinity Technologies, Inc., dated July 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:

July 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 Publishes New Clinical Framework Addressing Growing Market for Pulmonary Nodule Risk Stratification and Early Lung Cancer

Detection Using CyPath® Lung

Comprehensive

clinical review outlines specialty-specific approaches for integrating the test’s lung microenvironment analysis into diagnostic

pathway

Framework

includes protocols for pulmonology, primary care and oncology practices for detection of lung cancer and surveillance of survivors

SAN

ANTONIO, TX – July 27, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused

on noninvasive diagnostics and early cancer detection, today announced the publication of a comprehensive clinical review and white

paper authored by Chief Medical Officer Gordon H. Downie, MD, PhD, that presents a practical clinical framework for incorporating

CyPath® Lung into pulmonary nodule evaluation and cancer surveillance.

Titled

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

Testing for Early Diagnosis of Lung Cancer,” the paper examines the growing clinical challenge of evaluating pulmonary nodules

as lung cancer screening expands, incidental findings increase, artificial intelligence identifies even more incidental nodules, and

more patients require long-term surveillance following cancer treatment.

“Pulmonary

medicine is entering a new era in which clinicians are evaluating more pulmonary nodules than ever before, driving a rapidly growing

need for better risk stratification,” said Maria Zannes, President and Chief Executive Officer of bioAffinity Technologies. “Dr.

Downie’s white paper demonstrates how CyPath® Lung can provide physicians with clinically meaningful information

that complements imaging and clinical assessment, helping them make more confident decisions about which patients require invasive procedures

and which can be safely monitored.”

Drawing

on the three years of commercial experience since CyPath® Lung entered the market, the publication discusses how the noninvasive

test has demonstrated consistent clinical performance in helping physicians stratify malignancy risk and guide patient management, including

clinical case studies illustrating how CyPath® Lung helped clarify challenging cases in which imaging findings and predictive

models alone produced uncertain or conflicting assessments.

The

publication explores how advances in understanding the lung microenvironment are reshaping the evaluation of pulmonary nodules. Unlike

blood-based diagnostics, CyPath® Lung analyzes sputum collected directly from the lungs, providing objective, real-time

information from the lung microenvironment to help clarify complex or conflicting clinical presentations.

The

paper also reviews the strengths and limitations of existing predictive models and emphasizes that no single diagnostic tool should be

used in isolation. Instead, it proposes specialty-specific clinical pathways that integrate CyPath® Lung into three care

settings:

● Primary

care practices managing incidentally discovered pulmonary nodules

● Pulmonary

nodule programs and interventional pulmonology practices evaluating patients for biopsy

● Oncology

practices conducting surveillance of cancer survivors

“Every

patient presents a unique clinical picture,” Dr. Downie said. “The objective is not to replace clinician gestalt or existing

guidelines, but to provide an additional data point when clinical findings are uncertain or contradictory. CyPath® Lung’s

interrogation of the lung microenvironment gives physicians information that has not previously been available through traditional imaging

or blood-based testing.”

The

white paper highlights the growing recognition that the lung possesses a unique microenvironment distinct from blood, reflecting local

immune responses, inflammation, genetic alterations and tumor biology. By evaluating sputum directly from the lungs, CyPath®

Lung measures these biologic changes and identifies porphyrin-labeled malignant cells through proprietary flow cytometry and artificial

intelligence analysis.

The

complete white paper is available at https://bit.ly/cypath-lung-whitepaper3

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.

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. Important factors that could cause actual results to differ materially from current expectations include,

among others, the Company’s ability to achieve physician adoption of the clinical framework and specialty-specific pathways described

in the white paper, the assumption that expansion of lung cancer screening programs and increases in incidental pulmonary nodule findings

will result in increased demand for CyPath® Lung, the Company’s ability to expand its customer base across pulmonology,

primary care and oncology practices, the risk that competing diagnostic technologies including blood-based tests may achieve greater

market acceptance, 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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