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Form 8-K

sec.gov

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-015445

Filed: 2026-04-07

Period: 2026-04-07

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): April 7, 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))

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 ☒

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

April 7, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that its CyPath®

Lung test will be featured a the invitation-only “Advances in Early Lung Cancer Detection” symposium at the Cleveland Clinic

in Cleveland, Ohio, on April 16, 2026.

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 April 7, 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:

April 7, 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

bioAffinity

Technologies’ CyPath® Lung to be Featured at Cleveland Clinic Annual “Advances in Early Lung Cancer Detection”

Symposium April 16

Invitation-only

conference focuses on the evolving landscape of lung cancer risk and early detection when the disease is most treatable

bioAffinity

Technologies Chief Medical Officer Gordon Downie, MD, PhD, to participate in panel on lung nodule management

SAN

ANTONIO, TX – April 7, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused

on noninvasive diagnostics and early cancer detection, announces that its CyPath® Lung test will be featured at

the invitation-only “Advances in Early Lung Cancer Detection” symposium at the Cleveland Clinic in Cleveland, Ohio, on April

16, 2026. Gordon Downie, MD, PhD, bioAffinity Technologies’ Chief Medical Officer, will be one of three panelists discussing lung

nodule management and highlighting the benefits of using CyPath® Lung to aid in the early detection of lung cancer in

high-risk patients.

The

seventh annual Cleveland Clinic symposium brings together global leaders in the field of lung cancer, including physicians, advocacy

organizations, researchers and industry, to accelerate the development and implementation of new technologies and methods to find lung

cancer at the earliest stages when it is most treatable. This is bioAffinity Technologies’ seventh invitation to present before

symposium attendees.

This

year’s agenda addresses lung cancer risk assessment, emerging diagnostic technologies, screening biomarkers and artificial intelligence

(AI) as well as the changing epidemiology of lung cancer.

“As

the number of indeterminate pulmonary nodules discovered incidentally and by lung screening continues to grow, so does the accompanying

need for noninvasive, scalable diagnostic solutions,” Dr. Downie said. “CyPath® Lung directly addresses many

of the issues that will be discussed at the Cleveland Clinic’s symposium. Using our sputum-based diagnostic as an adjunct to the

current standard of care for newly discovered non-calcified pulmonary nodules helps guide difficult clinical discussions, accelerates

diagnosis and prevents unnecessary invasive procedures. Adding CyPath® Lung to the diagnostic pathway provides actionable

results to physicians, eases anxiety for patients, and can reduce costs to the healthcare system.”

CyPath®

Lung is a noninvasive, cost-effective diagnostic test that uses flow cytometry and AI to analyze the lung microenvironment and identify

cancer and cancer-related cells. Clinical data and case studies have shown its potential to detect cancer as early as Stage 1A, while

a negative result can help avert unnecessary and often risky invasive procedures.

With

both high sensitivity and specificity, CyPath® Lung is a balanced test that supports clinical decision-making and is broadly

applicable in high-risk patients, regardless of nodule size or prior cancer history. Initially designed to assist in the evaluation of

indeterminate pulmonary nodules identified through screening or incidental imaging, CyPath® Lung can also be used to monitor

lung cancer survivors for recurrence.

About

CyPath® Lung

CyPath®

Lung by bioAffinity Technologies is a noninvasive test designed to aid in 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 may indicate malignancy. CyPath® Lung incorporates a fluorescent porphyrin that is preferentially taken up

by cancer and cancer-related cells. CyPath® Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in detecting lung

cancer in patients at high risk for the disease who had small indeterminate lung nodules less than 20 millimeters. Results may vary in

broader clinical use.

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 evolving regulatory landscape for Laboratory Developed Tests, including potential increased oversight by the U.S. Food

and Drug Administration, the Company’s ability to achieve and maintain market acceptance of CyPath® Lung, the Company’s

ability to obtain adequate financing to fund operations, risks related to the commercialization 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

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