Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-045867

Filed: 2026-10-06

Period: 2026-10-06

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 6, 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))

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 ☒

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.

October 6, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that sales of its CyPath® Lung test for lung cancer increased more than 100% through the third quarter of 2026 compared to 2025,

reflecting continued growth in clinical adoption of the Company’s noninvasive test for assessing the likelihood of lung cancer

in high-risk individuals.

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 6, 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 6, 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

News

Release

bioAffinity

Technologies Reports Over 100% Growth in CyPath® Lung Sales Through Third Quarter 2026

Nearly

90% increase in number of physician offices using CyPath Lung

Utilization

expands as physicians who ordered CyPath Lung in 2025 increase usage by nearly 50%

SAN

ANTONIO, TEXAS — October 6, 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 sales of its

CyPath® Lung test for lung cancer increased more than 100% through the third quarter of 2026 compared to 2025, reflecting continued

growth in clinical adoption of the Company’s noninvasive test for assessing the likelihood of lung cancer in high-risk individuals.

The

number of ordering physicians increased by 89% in Q3 2026 compared to Q3 2025. Physicians who ordered CyPath Lung through Q3 2025 continued

to expand utilization of the test, with sales volume increasing by 48% year-over-year. Testing through Q3 2026 resulted in more than

1620 tests delivered as compared to 775 tests through Q3 2025.

“One

of our objectives for 2026 is executing on our strategy to expand access and drive adoption of CyPath Lung with physicians who have used

our test over time. We believe that sales of CyPath Lung in the third quarter of this year demonstrate the ongoing success of our efforts,”

said Maria Zannes, President and CEO of bioAffinity Technologies. “The 100% increase in third-quarter sales reflects growing utilization

of CyPath Lung in pulmonology and oncology practices, lung nodule clinics and community medical centers. As we continue to increase our

marketing efforts, we believe we are well positioned to pursue similar results generated by a larger base of physician prescribers. We

are especially focused on executing our new distribution agreement with Veteran-Owned AvMEDICAL, which we believe could help broaden

our reach in the government healthcare system, including the Department of Veterans Affairs.”

The

number of patients identified with indeterminate pulmonary nodules continues to rise, driven in part by increases in incidental findings

and screening by low-dose CT for high-risk patients. CyPath Lung’s flow cytometry+AI technology provides actionable information

to support clinical decision-making. The test result is intended to be used in conjunction with other clinical information, including

imaging, medical history, risk factors and clinical guidelines.

“As

clinicians, we are happy to see more eligible patients undergoing the recommended lung cancer screening. But as more nodules are identified

by imaging, physicians increasingly need more information to help determine the appropriate next steps for individual patients,”

said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies. “CyPath Lung is designed to help fill that need

by providing a result indicating either likely or unlikely malignancy in the lung, which can be considered alongside imaging, clinical

history and other findings to help determine whether a patient is most likely to benefit from additional monitoring, further diagnostic

evaluation or an invasive procedure.”

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) and is not intended for use as a sole

diagnostic tool and should be considered alongside other clinical findings. 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, that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied

by any forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding

the Company’s expectations of continued growth in sales, physician adoption or utilization of CyPath Lung; the anticipated benefits

of the distribution agreement and collaboration with AvMEDICAL, including expected expansion of government and agency access to and adoption

of CyPath Lung, and expectations regarding growth in demand for, or use of, CyPath Lung moving forward; the Company’s ability to

maintain and expand adoption of CyPath Lung as a Laboratory Developed Test, including compliance with evolving CLIA and FDA regulatory

requirements applicable to laboratory developed tests; the Company’s need for additional capital and ability to obtain financing

on acceptable terms, or at all; competition from other diagnostic technologies and companies; 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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