# EDGAR Filing Document

**Accession Number:** 0001712762
**File Stem:** 0001493152-26-014653
**Filing Date:** 2026-4
**Character Count:** 14174
**Document Hash:** b27a82d7391c3a68a9efda78374f8347
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-26-014653.hdr.sgml**: 20260401

**ACCESSION NUMBER**: 0001493152-26-014653

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260401

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20260401

**DATE AS OF CHANGE**: 20260401

**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:** 26828395

**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): **April 1, 2026**

**bioAffinity Technologies, Inc.**

(Exact name of registrant as specified in its charter)

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| | | |
|:---|:---|:---|
| **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 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.

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 April 1, 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.

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| | | |
|:---|:---|:---|
| Date: April 1, 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**

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| | |
|:---|:---|
| ![](ex99-1_001.jpg) | **News Release**  |

---

**bioAffinity Technologies' CyPath<sup>®</sup> 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 – <u>bioAffinity Technologies, Inc.</u> (Nasdaq: BIAF; BIAFW)**, a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced that unit sales for its <u>CyPath<sup>®</sup> Lung</u> 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<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> Lung into clinical workflows for lung cancer risk assessment and nodule management.

Based on audited financial results, CyPath<sup>®</sup> 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<sup>®</sup> 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<sup>®</sup> Lung.

● Broader use of CyPath<sup>®</sup> 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<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. CyPath<sup>®</sup> 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, <u>CyPath<sup>®</sup> Lung</u>, 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 <u>Precision Pathology Laboratory Services</u>, 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 Company's ability to successfully commercialize and achieve market acceptance of CyPath<sup>®</sup> 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

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