Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-016486

Filed: 2026-04-14

Period: 2026-04-14

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): April 14, 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.

April 14, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

a new clinical case study illustrating how CyPath® Lung, the Company’s noninvasive sputum-based diagnostic test, helped determine

next steps for a high-risk patient with a suspicious pulmonary nodule where imaging and risk models suggested a high likelihood of cancer,

but the physician suspected possible inflammation.

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 14, 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 14, 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

New

Case Study: bioAffinity Technologies’ CyPath® Lung Diagnostic Supports Physician’s Assessment, Prompts Follow-Up Imaging

and Defers Unnecessary Biopsy

Standard-of-care

imaging and risk models indicated cancer after lung screening revealed 30-millimeter pulmonary nodule

CyPath®

Lung test affirmed physician’s assessment that the nodule could be inflammation, not cancer; nodule resolved upon follow-up scan

Noninvasive

CyPath® Lung performed with 92% sensitivity, 87% specificity and 88% accuracy for detecting lung cancer in more difficult to diagnose small

nodules in a clinical trial of patients at high risk for lung cancer

SAN

ANTONIO, TX – April 14, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing

noninvasive diagnostics for lung cancer and other lung diseases, today released a new clinical case study illustrating how CyPath®

Lung, the Company’s noninvasive sputum-based diagnostic test, helped determine next steps for a high-risk patient with a suspicious

pulmonary nodule where imaging and risk models suggested a high likelihood of cancer, but the physician suspected possible inflammation.

The

patient, a 70-year-old female with a 50 pack-year smoking history and smoking-related emphysema, presented with increased symptoms including

cough, sputum production and shortness of breath. A low-dose CT scan identified a suspicious 30-millimeter (mm) lesion in the lower right

lung with nearby enlarged lymph nodes, findings that can be associated with lung cancer. PET imaging suggested a high likelihood of malignancy.

Lung cancer risk calculators estimated the probability of cancer as high on the Mayo and Herder models and intermediate on the Brock

model.

“In

this case, imaging findings and risk calculators suggested a very high probability of lung cancer, and we scheduled her for biopsy,”

said Daya Nadarajah, MD, the treating pulmonologist. “I routinely use CyPath® Lung in my practice and ordered the test for

her. She received a negative result, ‘Unlikely Malignancy,’ which prompted another scan before we moved forward with the

biopsy.”

-1-

follow-up CT scan showed that the concerning 30-mm nodule had completely resolved, confirming the physician’s acumen that the abnormality

was due to a reversible inflammatory process rather than lung cancer.

“In

patients with underlying lung disease, like emphysema, or other comorbidities like cardiovascular disease, biopsy can carry significant

risks. Physicians must weigh the risks against the potential benefits,” said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity

Technologies. “Adding CyPath® Lung to the diagnostic pathway for indeterminate nodules provides additional objective data that

can be very valuable when assessing patients with complicating health conditions. In this patient’s case, CyPath® Lung supported

additional imaging before biopsy which resulted in saving the patient from a risky, costly and unnecessary procedure.”

This

case highlights how CyPath® Lung can assist physicians with pulmonary nodule management by helping physicians confidently defer unnecessary

– and often risky – invasive procedures. This case study is illustrative of a single patient experience and does not establish

generalized clinical utility.

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 clinical trial of high-risk patients, 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. CyPath® Lung 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), administered by the Centers for Medicare & Medicaid Services. For more information, visit www.bioaffinitytech.com.

-2-

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 ability of CyPath® Lung to indicate the probability of lung cancer, CyPath® Lung providing confidence in a

proposed course of action for high-risk patients, the ability of CyPath® Lung to determine if cancer is present or if the patient

is cancer-free, 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

-3-

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