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bioAffinity Technologies (NASDAQ: BIAF) shows asthma and COPD diagnostic data

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(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

bioAffinity Technologies, Inc. reported that it presented a scientific poster titled “Sputum as a Diagnostic Tool for the Treatment of Asthma” at the 2026 American Academy of Allergy, Asthma and Immunology meeting in Philadelphia. The work highlights a noninvasive sputum-based diagnostic approach.

The research describes using bioAffinity’s platform to identify antibody drug receptors in sputum for asthma and COPD therapies, including dupilumab and benralizumab, to help match patients with effective biologic treatments and monitor inflammatory changes. The company notes this platform underpins its commercial CyPath® Lung test, which in clinical studies showed 92% sensitivity, 87% specificity and 88% accuracy for early lung cancer detection.

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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): March 3, 2026

 

bioAffinity Technologies, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-41463   46-5211056

(State or other jurisdiction

of 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

 

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 March 3, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing that it presented a poster entitled “Sputum as a Diagnostic Tool for the Treatment of Asthma” (the “Poster”) at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2026 annual meeting in Philadelphia, PA, on March 1, 2026. The Poster reports on the Company’s development of clinical diagnostics that may assist physicians in matching asthma and COPD patients with effective therapies and how monitoring inflammatory changes over time can improve outcomes and lower the cost of healthcare.

 

Copies of the press release and Poster are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively and are 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 March 3, 2026
99.2   Poster entitled “Sputum as a Diagnostic Tool for the Treatment of Asthma
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: March 3, 2026 BIOAFFINITY TECHNOLOGIES, INC.
   
  By: /s/ Maria Zannes
  Name: Maria Zannes
  Title: President and Chief Executive Officer

 

-3-

 

 

Exhibit 99.1

 

 

bioAffinity Technologies Presents Positive Research Findings for its Novel Diagnostic Platform Technology to Identify Optimal Therapies for Asthma Patients

 

Poster presented to medical and drug industry conferees at prestigious American Academy of Allergy, Asthma & Immunology (AAAI) Annual Meeting

 

Research demonstrates the technology’s ability to identify drug antibody receptors in sputum for two leading asthma therapies

 

SAN ANTONIO, TX – March 3, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company focused on noninvasive diagnostics and early cancer detection, today announced the presentation of a new scientific poster reporting on the ability of the Company’s innovative diagnostic approach to identify antibody drug receptors in sputum, including receptors for dupilumab, a leading therapy for asthma and chronic obstructive pulmonary disease (COPD), and benralizumab, another asthma therapy. The research advances the Company’s pipeline tests aimed at guiding personalized treatment decisions and improving disease monitoring for asthma and COPD sufferers.

 

The poster, “Sputum as a Diagnostic Tool for the Treatment of Asthma,” was presented at the American Academy of Allergy, Asthma and Immunology (AAAAI) 2026 annual meeting in Philadelphia on March 1 by William Bauta, PhD, Chief Science Officer of bioAffinity Technologies. The research reports on the Company’s development of clinical diagnostics that may assist physicians in matching asthma and COPD patients with the most effective therapies and monitoring inflammatory changes over time to improve outcomes and lower the cost of healthcare.

 

“Asthma and COPD impact approximately 650 million children and adults globally. The good news is that there are very effective treatments for asthma and COPD that work well for some sufferers. However, many patients must try a series of different types of treatments before finding an effective therapy,” Dr. Bauta said. “We are leveraging our expertise in using our proprietary flow cytometry platform equipped with automated AI analysis to develop tests that match asthma and COPD patients with the most appropriate biologic therapies and monitor their ongoing conditions.”

 

bioAffinity’s technology platform is successfully used with its commercial test, CyPath® Lung, a noninvasive diagnostic test for lung cancer that has demonstrated high sensitivity and specificity for patients with small pulmonary nodules in detecting lung cancer as early as curative Stage 1A.

 

 

 

 

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. Clinical study results 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.

 

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. 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, risks and uncertainties related to scientific research and development; the Company’s ability to develop, validate, obtain regulatory or other required clearances or approvals for, commercialize and achieve market acceptance of its diagnostic tests and related technologies; variability in clinical and real-world performance; the availability of sufficient data and sample sizes; changes in standards of care, competitive products and technologies; intellectual property protection; reliance on third parties; manufacturing and supply matters; reimbursement and coverage; and general economic, market and industry conditions; and the other factors discussed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, 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

 

 

 

 

Exhibit 99.2

 

 

 

 

FAQ

What did bioAffinity Technologies (BIAF) announce in this 8-K filing?

bioAffinity Technologies announced the presentation of a new scientific poster at the 2026 AAAAI meeting. The poster describes a sputum-based diagnostic approach designed to better match asthma and COPD patients with biologic therapies and track inflammatory changes to potentially improve outcomes and healthcare costs.

What is the focus of bioAffinity Technologies’ new asthma and COPD research?

The research focuses on using sputum as a diagnostic tool to identify antibody drug receptors for asthma and COPD therapies. It aims to guide personalized treatment selection and monitor inflammatory changes over time, potentially helping physicians choose more effective biologic drugs for individual patients.

Which asthma therapies are highlighted in bioAffinity Technologies’ sputum research?

The research highlights detecting receptors in sputum for dupilumab, a leading therapy for asthma and COPD, and benralizumab, another asthma therapy. Identifying these receptors may help determine which patients are more likely to respond to these biologic treatments and support more targeted therapy decisions.

How does this asthma research relate to bioAffinity’s CyPathae Lung test?

The same technology platform used in this asthma and COPD research underlies CyPathae Lung, bioAffinity’s commercial noninvasive lung cancer test. CyPathae Lung uses flow cytometry and AI on sputum samples to identify malignant cell populations and support earlier detection of lung cancer in high-risk patients.

What performance has CyPathae Lung demonstrated in clinical studies?

CyPathae Lung demonstrated 92% sensitivity, 87% specificity and 88% accuracy in clinical studies for detecting lung cancer. The test is designed for high-risk patients with small indeterminate lung nodules under 20 millimeters, aiming to improve early-stage lung cancer detection using noninvasive sputum analysis.

What diseases does bioAffinity Technologies (BIAF) aim to address with its diagnostics?

bioAffinity Technologies develops noninvasive diagnostics for early-stage lung cancer and other lung diseases, and is advancing tests for asthma and COPD. Its first product, CyPathae Lung, targets early lung cancer detection, while its new research focuses on improving treatment selection and monitoring for asthma and COPD patients.

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bioAffinity Tech

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