# EDGAR Filing Document

**Accession Number:** 0001712762
**File Stem:** 0001493152-26-025338
**Filing Date:** 2026-5
**Character Count:** 11849
**Document Hash:** 012f925be33fbbd798f154375cbe8be5
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-26-025338.hdr.sgml**: 20260527

**ACCESSION NUMBER**: 0001493152-26-025338

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 15

**CONFORMED PERIOD OF REPORT**: 20260527

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260527

**DATE AS OF CHANGE**: 20260527

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** bioAffinity Technologies, Inc.
- **CENTRAL INDEX KEY:** 0001712762
- **STANDARD INDUSTRIAL CLASSIFICATION:** SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731]
- **ORGANIZATION NAME:** 08 Industrial Applications and Services
- **EIN:** 465211056
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-41463
- **FILM NUMBER:** 261022246

**BUSINESS ADDRESS:**
- **STREET 1:** 3300 NACOGDOCHES ROAD
- **STREET 2:** SUITE 216
- **CITY:** SAN ANTONIO
- **STATE:** TX
- **ZIP:** 78217
- **BUSINESS PHONE:** 210-698-5334

**MAIL ADDRESS:**
- **STREET 1:** 3300 NACOGDOCHES ROAD
- **STREET 2:** SUITE 216
- **CITY:** SAN ANTONIO
- **STATE:** TX
- **ZIP:** 78217

?xml version='1.0' encoding='ASCII'?

**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): **May 27, 2026**

**bioAffinity Technologies, Inc.**

(Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-41463** | **46-5211056** |
| (State or other jurisdiction<br> of incorporation) | (Commission<br> File Number) | (I.R.S. Employer<br> 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<br>| BIAF<br>| The Nasdaq Stock Market LLC<br> (Nasdaq Capital Market) |
| Warrants to purchase Common Stock | BIAFW | The Nasdaq Stock Market LLC<br> (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 May 27, 2026, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that it has received notification of allowance from the Mexican Institute of Industrial Property for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry.

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.

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| | |
|:---|:---|
| **Exhibit<br> Number** | **Description** |
| 99.1 | [Press Release issued by bioAffinity Technologies, Inc., dated May 27, 2026](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the XBRL document) |

---

**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: May 27, 2026 | **BIOAFFINITY TECHNOLOGIES, INC.** | **BIOAFFINITY TECHNOLOGIES, INC.** |
|  | By: | */s/ Maria Zannes* |
|  | Name: | Maria Zannes |
|  | Title: | President and Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

---

| | |
|:---|:---|
| ![](ex99-1_001.jpg) | ![](ex99-1_002.jpg) |

---

**bioAffinity Technologies Announces Notification of Mexico Patent Allowance Covering Novel Lung Cancer Detection Methods Using CyPath<sup>®</sup> Lung Technology**

***Strong intellectual property portfolio helps build shareholder value***

 

***Patent strategy protects CyPath<sup>®</sup> Lung's flow cytometry-driven diagnostic approach in international markets***

 ****

**SAN ANTONIO, Texas – May 27, 2026 – <u>bioAffinity Technologies, Inc.</u> (Nasdaq: BIAF; BIAFW),** a biotechnology company advancing early-stage cancer diagnostics including <u>CyPath<sup>®</sup> Lung</u>, the Company's commercially available test for early-stage lung cancer, today announced it has received notification of allowance from the Mexican Institute of Industrial Property for a patent application related to methods of predicting the likelihood of lung cancer using flow cytometry.

Upon issuance, the Mexican patent application will protect the use of defined antibodies and the porphyrin TCPP to label cell populations in sputum and the use of flow cytometry to determine the presence of lung cancer cells in sputum.

"This patent expands our global intellectual property portfolio and protection of CyPath<sup>®</sup> Lung's proprietary approach to detecting lung cancer at its earliest and most treatable stages," said Maria Zannes, President and CEO of bioAffinity Technologies. "The integration of advanced cell biology, flow cytometry and AI into an easy-to-use, noninvasive test clearly differentiates our technology, which is designed to support clinicians in evaluating indeterminate pulmonary nodules and high-risk patients."

CyPath<sup>®</sup> Lung uses flow cytometry and artificial intelligence with at-home sample collection to assess indeterminate pulmonary nodules in high-risk patients. Physicians are adding CyPath<sup>®</sup> Lung to the clinical pathway to help risk stratify patients, reduce patient anxiety, support surgical and treatment decision-making, and reduce overall healthcare costs.

The patent further strengthens the Company's intellectual property (IP) portfolio supporting its flow cytometry-based CyPath<sup>®</sup> Lung diagnostic platform, which now includes multiple patents in the United States, the European Union, China, Japan, Australia, Canada and Mexico. "Strong intellectual property protection for CyPath<sup>®</sup> Lung benefits not only patients and their physicians, but also supports value creation for our shareholders," Ms. Zannes said.

**About CyPath<sup>®</sup> Lung**

CyPath<sup>®</sup> 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<sup>®</sup> Lung uses advanced flow cytometry and proprietary artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. CyPath<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> Lung, is a noninvasive test that has shown high sensitivity, specificity and accuracy for the detection of early-stage lung cancer. CyPath<sup>®</sup> 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 <u>www.bioaffinitytech.com</u>.

**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 risk that pending patent applications may not result in issued patents, changes in the regulatory framework governing Laboratory Developed Tests including potential increased FDA oversight, the Company's ability to successfully commercialize CyPath<sup>®</sup> Lung in domestic and international markets, the Company's ability to realize value from its international intellectual property portfolio, the sufficiency of the Company's capital resources, 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

<u>investors@bioaffinitytech.com</u>