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Form 8-K

sec.gov

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-038897

Filed: 2026-08-18

Period: 2026-08-18

CIK: 0001712762

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

Item: Other Events

Item: Financial Statements and Exhibits

Documents

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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): August 18, 2026

bioAffinity

Technologies, Inc.

(Exact

name of registrant as specified in its charter)

Delaware

001-41463

46-5211056

(State or other jurisdiction

(Commission

(I.R.S. Employer

of incorporation)

File Number)

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

August 18, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing

that it has entered into a distribution agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business (SDVSB) and established

distributor of premium medical and surgical laboratory services, supplies and equipment to government agencies.

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 August 18, 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: August 18, 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 and AvMEDICAL Announce Nationwide Federal Healthcare Distribution Agreement for CyPath® Lung

New

partner’s national sales force will market CyPath Lung to federal healthcare agencies, including VA medical centers nationwide

Agreement

significantly expands bioAffinity’s commercial reach through AvMEDICAL’s existing sales team

Service-Disabled

Veteran-Owned AvMEDICAL provides access to established government procurement channels

SAN

ANTONIO, Texas – August 18, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company

focused on noninvasive diagnostics for the early detection of lung cancer and other lung diseases, today announced it has entered into

a distribution agreement with AvMEDICAL, a Service-Disabled Veteran-Owned Small Business (SDVOSB) and established distributor of premium

medical-surgical and laboratory services, supplies and equipment to government agencies.

The

distribution agreement is expected to strengthen bioAffinity’s ability to commercialize CyPath® Lung within the government

healthcare market by leveraging AvMEDICAL’s established procurement channels, government contracting expertise and existing customer

relationships. bioAffinity and AvMEDICAL will develop co-branded marketing materials, and AvMEDICAL’s sales team will actively

promote CyPath Lung to its federal customers, including the U.S. Department of Veteran Affairs (VA).

As

an SDVOSB with access to indefinite-delivery, indefinite-quantity (IDIQ) contracts, AvMEDICAL can provide an important advantage for

expanding adoption of CyPath Lung across government healthcare systems by simplifying the procurement process. The agreement expands

bioAffinity’s commercial reach into the government healthcare supply chain and provides an additional channel for veterans to access

CyPath Lung.

“AvMEDICAL’s

established presence in the government healthcare marketplace and experienced sales organization will expand our commercial pathway to

reach physicians and patients who may benefit from our noninvasive diagnostic to assess lung cancer risk, manage pulmonary nodules and

monitor cancer survivorship,” said Maria Zannes, President and CEO of bioAffinity Technologies. “According to the VA, nearly

8,000 veterans are diagnosed with lung cancer and approximately 5,000 will die from the disease annually, making lung cancer a high priority

in VA healthcare systems. Early detection is the best way to save lives, and in multiple case studies, CyPath Lung has demonstrated its

ability to detect lung cancer as early as curative Stage 1A. We believe working with AvMEDICAL will help us build on our commercial momentum

and expand access to CyPath Lung among a vulnerable population.”

“CyPath

Lung is a compelling addition to our product portfolio because it meets an unmet need in the diagnostic pathway for lung cancer and can

improve patient outcomes among our veterans and active-duty military personnel,” said Troy Mizell, President and CEO of AvMEDICAL.

“Our deep understanding of government contracting and the healthcare supply chain will help us deliver greater value to our government

customers while expanding access to an innovative technology for the patients they serve.”

CyPath

Lung is designed to provide physicians with additional information when evaluating patients with indeterminate pulmonary nodules and

may be used in conjunction with imaging and other diagnostic tools. The test is performed by Precision Pathology Laboratory Services

(PPLS), a CLIA-certified, CAP-accredited laboratory and a wholly owned subsidiary of bioAffinity Technologies.

About

AvMedical

AvMEDICAL

is a Service-Disabled Veteran-Owned Small Business (SDVOSB) that sources premium medical-surgical and laboratory supplies and equipment

from top-tier manufacturers to the government healthcare system. Since 2020, AvMEDICAL has more than doubled its product portfolio to

provide enhanced product offerings to its federal government customers. The portfolio covers key categories, including remote cardiac

monitoring, ultrasound, advanced bedside monitors, infusion systems, incontinence products for both hospital and home use, and best-in-class

laboratory and respiratory testing solutions.

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 successfully commercialize CyPath Lung through AvMEDICAL’s distribution channels,

risks related to government contracting and procurement processes, uncertainties regarding the adoption of CyPath Lung by government

healthcare providers, the Company’s reliance on third-party distributors for market access, 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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