Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-041020

Filed: 2026-09-01

Period: 2026-09-01

CIK: 0001712762

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-99.1 (ex99-1.htm)

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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): September 1, 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.

September 1, 2026, bioAffinity Technologies, Inc., a Delaware corporation issued a press release announcing that it is advancing the

potential application of its CyPath® Lung test for the surveillance of lung cancer patients.

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 September 1, 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:

September 1, 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 Advances CyPath® Lung for Surveillance of Lung Cancer Survivors

than 680,000 Americans living with a history of lung cancer represent a significant population requiring ongoing surveillance

Noninvasive

CyPath® Lung has the potential to complement imaging in monitoring for lung cancer recurrence and new cancers

SAN

ANTONIO, Texas – September 1, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced that it is advancing

the potential application of its CyPath® Lung test for surveillance of lung cancer patients who have completed curative-intent

treatment.

Lung

cancer recurrence remains a significant clinical challenge. According to the American Cancer Society, there were more than 680,000 Americans

living with a prior lung cancer diagnosis as of January 1, 2025.1 The National Cancer Institute estimates that another 230,000

patients will be diagnosed with lung cancer in 2026.

“For

patients who have completed cancer treatment, the discovery of a new pulmonary nodule can create tremendous uncertainty. Imaging alone

cannot tell us if it is recurrent cancer, a new cancer, or benign post-treatment changes including fibrosis, scarring, and treatment-related

inflammation,” said Vijay Gunuganti, MD, an oncologist with Texas Oncology, a physician-led practice in San Antonio, Texas. “CyPath

Lung can provide additional information without immediately subjecting the patient to an invasive procedure. The test’s binary

result – unlikely or likely malignancy – can help us determine which patients need closer investigation and which patients

may be appropriate for continued surveillance.”

“CyPath

Lung has demonstrated its ability to detect early-stage lung cancer in clinical trials and clinical practice,” said Maria Zannes,

President and CEO of bioAffinity Technologies. “As our commercial experience with CyPath Lung grows, we are examining how our noninvasive

approach may provide value throughout the patient’s lung cancer journey. We believe surveillance after cancer treatment has the

potential to lead to earlier intervention and could be an important complement to early detection for newly diagnosed patients in terms

of improving patient outcomes.”

https://doi.org/10.3322/caac.70011Digital Object Identifier (DOI)

Even

when patients have no evidence of disease (NED) following surgery or radiation, published studies report recurrence rates of approximately

20% to 55% for non-small cell lung cancer (NSCLC), depending on stage, treatment and other factors.2 The American Society

of Clinical Oncology (ASCO) recommends surveillance imaging every six months for two years following curative-intent treatment of stage

I–III NSCLC, followed by annual low-dose CT to monitor for new primary lung cancers.3

“Finishing

curative-intent treatment is not the end of cancer care. As survival rates continue to improve and more people with a cancer diagnosis

are living longer lives, survivorship care is increasingly important. That means proactive follow-up for recurrence, screening for new

cancers and monitoring for long-term treatment effects,” said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies.”

CyPath Lung complements CT surveillance by providing actionable information that helps physicians evaluate new or changing pulmonary

nodules identified by imaging.”

The

potential role of CyPath Lung in recurrence surveillance builds on the test’s ability to analyze the lung microenvironment in real

time. Drawing on three years of commercial experience, CyPath Lung has shown promising clinical performance in helping physicians stratify

malignancy risk and guide patient management, including clinical case studies that illustrate how CyPath Lung helped clarify challenging

cases in which imaging findings and predictive models alone produced uncertain or conflicting assessments.

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. These clinical performance data relate to CyPath Lung’s use in the detection

setting and have not been separately validated for post-treatment surveillance. 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.

https://jtd.amegroups.org/article/view/108627/html

DOI: 10.1200/JOP.19.00722

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 successfully expand CyPath Lung into new clinical applications including post-treatment

surveillance, the availability and adequacy of clinical data to support new use cases, regulatory developments affecting laboratory developed

tests, the Company’s ability to maintain its Nasdaq listing and comply with applicable listing requirements, the Company’s

limited operating history and history of losses, 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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