Form 8-K

8-K — bioAffinity Technologies, Inc.

Accession: 0001493152-26-014653

Filed: 2026-04-01

Period: 2026-04-01

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 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.

April 1, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that unit sales for its CyPath®

Lung diagnostic in the first quarter of 2026 exceeded internal projections and achieved, based on preliminary unaudited data, 146% growth

compared to the first quarter of 2025, reflecting accelerating physician adoption and expanding clinical use of the Company’s noninvasive

lung cancer diagnostic test.

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 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:

April 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

News Release

bioAffinity

Technologies’ CyPath® Lung Test Unit Sales Surged 146% Year-Over-Year in Q1 2026

Noninvasive

diagnostic continues to gain traction in the current and expanding U.S. addressable market of $3.58 billion for pulmonary nodule management

and surveillance of lung cancer survivors

Flow

cytometry+AI technology has potential to improve lung cancer risk assessment and nodule management

SAN

ANTONIO, TX – April 1, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused

on noninvasive diagnostics and early cancer detection, today announced that unit sales for its CyPath® Lung diagnostic

in the first quarter of 2026 exceeded internal projections and, based on preliminary unaudited data, achieved 146% growth compared to

the first quarter of 2025, reflecting accelerating physician adoption and expanding clinical use of the Company’s noninvasive lung

cancer diagnostic test.

“The

stronger than expected unit growth in the first quarter of 2026 reflects growing recognition of the value that CyPath®

Lung brings to clinical decision-making and patient outcomes,” said Maria Zannes, President and CEO of bioAffinity Technologies.

“Physicians are seeking more accurate, noninvasive tools to assess lung cancer risk and detect disease at its earliest, most treatable

stage. CyPath® Lung is designed to address a critical gap in the diagnostic pathway by supporting lung cancer risk assessment,

pulmonary nodule management and post-treatment surveillance. Our growing body of evidence – including real-world case studies –

further supports CyPath® Lung’s potential clinical utility.”

Addressing

a Large and Growing Clinical Need

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. This expanding patient population poses a diagnostic challenge for physicians who

have to weigh the benefits and risks of “watchful waiting” versus invasive procedures like biopsy.

Consistent

with estimates from the U.S. Preventive Services Task Force, the number of indeterminate pulmonary nodules detected in the U.S. through

lung cancer screening and incidental imaging is projected to grow 62% from 2.9 million in 2025 to 4.7 million in 2030. The number of

people living with a prior lung cancer diagnosis is projected to increase from 680,000 to more than 871,000 by 2030. Capturing only 10%

of both markets represents sales of $358 million for CyPath® Lung, growing to more than $560 million over the next five

years. The forecast assumes 10% compound annual growth from 2024–2030, driven by increased lung cancer screening adoption, improved

adherence to screening guidelines, and enhanced detection through AI-enabled imaging tools.

CyPath®

Lung’s flow cytometry+AI technology is designed to provide actionable information to support clinical decision-making by delivering

a binary result – “likely” or “unlikely” malignancy – to the ordering physician. Real-world patient

cases have suggested the test’s potential to:

● Help

detect lung cancer at Stage 1A, when it is most treatable, as observed in real-world clinical

cases.

● Help

avoid unnecessary invasive, risky, and costly procedures when the test result is negative

(“unlikely” malignancy), based on clinical experience to date.

Executing

a Focused Commercial Strategy

bioAffinity

Technologies has prioritized CyPath® Lung as its core commercial focus, aligning resources to accelerate adoption and

scale. Growth has been driven by:

● Expansion

of ordering physician sites.

● Increased

peer-to-peer education among pulmonologists.

● Integration

of CyPath® Lung into clinical workflows for lung cancer risk assessment and

nodule management.

Based

on audited financial results, CyPath® Lung revenue increased 87% year over year in 2025, while test units sold grew 99%

compared to 2024. These milestones, together with preliminary unaudited growth data for Q1 2026, support the initial phase of the Company’s

commercialization strategy and position CyPath® Lung for continued growth.

Positioned

for Continued Expansion

The

Company is advancing multiple initiatives to further expand the clinical impact of its proprietary technology platform, including:

● A

large-scale longitudinal clinical study designed to generate additional validation data for

CyPath® Lung.

● Broader

use of CyPath® Lung to monitor lung cancer survivors after treatment.

● An

R&D pipeline that includes diagnostic tests for asthma and COPD that will help guide

personalized treatment with targeted therapies.

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. 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 Company's ability to

successfully commercialize and achieve market acceptance of CyPath® Lung, the Company's ability to achieve and sustain

profitability, the preliminary and unaudited nature of certain financial and operating data presented herein, the Company's reliance

on a single commercial product, the outcome of ongoing and future clinical studies, the Company's ability to obtain and maintain adequate

reimbursement from third-party payors, the regulatory environment for laboratory developed tests, the Company's ability to attract and

retain qualified personnel, the Company's need for additional capital to fund operations, competition from existing and new diagnostic

technologies, 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

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