bioAffinity advances CyPath Lung for cancer follow-up

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Form Type

8-K

Rhea-AI Filing Summary

bioAffinity Technologies, Inc. (BIAF) reported that it is advancing the potential use of its noninvasive CyPath® Lung test for surveillance of lung cancer patients after curative-intent treatment. The company highlights a large survivorship population and positions CyPath Lung as a complement to CT imaging in monitoring pulmonary nodules for recurrence or new cancers.

CyPath Lung is a Laboratory Developed Test that analyzes sputum using flow cytometry, artificial intelligence and a fluorescent porphyrin to identify malignant and cancer-related cells. In a published trial in high-risk patients with small indeterminate nodules, CyPath Lung showed 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for early lung cancer detection, though these performance data have not been separately validated for post-treatment surveillance.

Filing Explained

CyPath Lung’s proposed surveillance use expands, but post-treatment performance remains separately unvalidated.

The filing announces that bioAffinity Technologies is advancing the potential use of CyPath Lung to monitor patients who completed curative-intent lung-cancer treatment; the immediate change is a proposed expansion of clinical scope, not a completed expansion of the test’s validated use.

The company presents CyPath Lung as a possible complement to imaging, but the performance data cited came from lung-cancer detection in high-risk patients and have not been separately validated for post-treatment surveillance.

The filing identifies the availability and adequacy of clinical data for this new use case, along with regulatory developments affecting laboratory-developed tests, as uncertainties for any future expansion.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Americans with prior lung cancer diagnosis: more than 680,000 Estimated new lung cancer diagnoses: 230,000 NSCLC recurrence rate range: approximately 20% to 55% +4 more

7 metrics

Americans with prior lung cancer diagnosis more than 680,000 Living with a prior lung cancer diagnosis as of January 1, 2025

Estimated new lung cancer diagnoses 230,000 National Cancer Institute estimate for 2026

NSCLC recurrence rate range approximately 20% to 55% Published studies for non-small cell lung cancer after surgery or radiation

CyPath Lung sensitivity 92% Detection of lung cancer in high-risk patients with small indeterminate nodules

CyPath Lung specificity 87% Detection setting clinical trial in high-risk patients

CyPath Lung accuracy 88% Detection of early-stage lung cancer in published clinical trial

CyPath Lung negative predictive value 99% High-risk patients with small indeterminate nodules less than 20 millimeters

Key Terms

Laboratory Developed Test, Clinical Laboratory Improvement Amendments, flow cytometry, negative predictive value, +2 more

6 terms

Laboratory Developed Test regulatory

"CyPath Lung is marketed as a Laboratory Developed Test (LDT)"

A laboratory developed test is a medical diagnostic created, validated and performed within a single clinical laboratory rather than sold as a boxed product to other labs or clinics. For investors, LDTs can offer faster product rollout and niche revenue streams like a custom service, but they also carry regulatory and reimbursement uncertainty and competitive risk—think of them as a handmade tool that can be quickly offered to customers but may face shifting rules or market limits.

Clinical Laboratory Improvement Amendments regulatory

"LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA)"

A U.S. federal regulatory program that sets quality, certification, and inspection rules for laboratories that perform tests on human specimens to diagnose, prevent, or treat disease. It requires labs to meet standards for personnel, equipment, procedures, and result accuracy, and to obtain appropriate certificates before reporting patient results. It matters to investors because compliance affects a lab’s ability to operate, sell tests, and generate revenue, and can influence costs, inspection risk, reimbursement, and market access—similar to a licensing and safety-inspection system for labs.

flow cytometry medical

"CyPath Lung uses advanced flow cytometry and proprietary artificial intelligence"

A laboratory method that uses lasers and sensors to count and analyze individual cells or tiny particles as they flow past a detector, like a high‑speed supermarket scanner that reads barcodes on each item. Investors care because flow cytometry is widely used in drug development, diagnostics and manufacturing quality control; demand for the instruments, reagents and services can signal progress in clinical programs, recurring revenue streams and adoption of new therapies or tests.

negative predictive value financial

"CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value"

Negative predictive value is a measure of how reliable a negative result is in confirming that a person or situation is truly free of a problem or condition. For investors, it indicates the likelihood that a negative signal or indicator truly means there is no risk or issue present, helping them assess how much trust to place in avoiding potential problems based on current information.

non-small cell lung cancer medical

"published studies report recurrence rates of approximately 20% to 55% for non-small cell lung cancer"

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

curative-intent treatment medical

"surveillance of lung cancer patients who have completed curative-intent treatment"

FAQ

What did bioAffinity Technologies (BIAF) announce regarding CyPath Lung?

bioAffinity Technologies announced it is advancing the potential application of its CyPath Lung test to help surveil lung cancer patients who have completed curative-intent treatment, positioning the noninvasive test as a complement to imaging when evaluating new or changing pulmonary nodules for possible malignancy or recurrence.

How is CyPath Lung intended to be used according to the BIAF 8-K?

CyPath Lung is described as a noninvasive sputum-based test that provides a binary result – “unlikely” or “likely” malignancy – to support physicians in stratifying malignancy risk, guiding patient management and complementing CT surveillance when imaging findings and predictive models are uncertain or conflicting.

What clinical performance has CyPath Lung shown in detection settings for BIAF?

In a published clinical trial of high-risk patients with small indeterminate lung nodules under 20 millimeters, CyPath Lung demonstrated 92% sensitivity, 87% specificity, 88% accuracy and 99% negative predictive value for detecting lung cancer. These data relate to detection and have not been separately validated for post-treatment surveillance.

How large is the potential lung cancer surveillance population cited by BIAF?

The release cites American Cancer Society data that more than 680,000 Americans were living with a prior lung cancer diagnosis as of January 1, 2025, and National Cancer Institute estimates that another 230,000 patients will be diagnosed with lung cancer in 2026, highlighting a substantial surveillance population.

What recurrence rates for non-small cell lung cancer are mentioned by BIAF?

bioAffinity Technologies notes that published studies report recurrence rates of approximately 20% to 55% for non-small cell lung cancer after surgery or radiation, depending on stage, treatment and other factors, underscoring the importance of ongoing surveillance even when patients initially have no evidence of disease.

How is CyPath Lung regulated and marketed according to the BIAF filing?

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, and the test is not intended as a sole diagnostic tool.

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Available on EDGAR 09/01/2026 - 04:31 PM Accepted by SEC EDGAR 09/01/2026 - 04:30 PM

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): September 1, 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 September 1, 2026, bioAffinity Technologies, Inc., a Delaware corporation issued a press release announcing that it is advancing the potential application of its CyPath® Lung test for the surveillance of lung cancer patients.

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 September 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: September 1, 2026	BIOAFFINITY TECHNOLOGIES, INC.

	By:	/s/ Maria Zannes
	Name:	Maria Zannes
	Title:	President and Chief Executive Officer

-3-

Exhibit 99.1

bioAffinity Technologies Advances CyPath^® Lung for Surveillance of Lung Cancer Survivors

More than 680,000 Americans living with a history of lung cancer represent a significant population requiring ongoing surveillance

Noninvasive CyPath^® Lung has the potential to complement imaging in monitoring for lung cancer recurrence and new cancers

SAN ANTONIO, Texas – September 1, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company developing noninvasive healthcare solutions for the early detection and monitoring of lung disease, today announced that it is advancing the potential application of its CyPath^® Lung test for surveillance of lung cancer patients who have completed curative-intent treatment.

Lung cancer recurrence remains a significant clinical challenge. According to the American Cancer Society, there were more than 680,000 Americans living with a prior lung cancer diagnosis as of January 1, 2025.¹ The National Cancer Institute estimates that another 230,000 patients will be diagnosed with lung cancer in 2026.

“For patients who have completed cancer treatment, the discovery of a new pulmonary nodule can create tremendous uncertainty. Imaging alone cannot tell us if it is recurrent cancer, a new cancer, or benign post-treatment changes including fibrosis, scarring, and treatment-related inflammation,” said Vijay Gunuganti, MD, an oncologist with Texas Oncology, a physician-led practice in San Antonio, Texas. “CyPath Lung can provide additional information without immediately subjecting the patient to an invasive procedure. The test’s binary result – unlikely or likely malignancy – can help us determine which patients need closer investigation and which patients may be appropriate for continued surveillance.”

“CyPath Lung has demonstrated its ability to detect early-stage lung cancer in clinical trials and clinical practice,” said Maria Zannes, President and CEO of bioAffinity Technologies. “As our commercial experience with CyPath Lung grows, we are examining how our noninvasive approach may provide value throughout the patient’s lung cancer journey. We believe surveillance after cancer treatment has the potential to lead to earlier intervention and could be an important complement to early detection for newly diagnosed patients in terms of improving patient outcomes.”

¹ https://doi.org/10.3322/caac.70011Digital Object Identifier (DOI)

Even when patients have no evidence of disease (NED) following surgery or radiation, published studies report recurrence rates of approximately 20% to 55% for non-small cell lung cancer (NSCLC), depending on stage, treatment and other factors.² The American Society of Clinical Oncology (ASCO) recommends surveillance imaging every six months for two years following curative-intent treatment of stage I–III NSCLC, followed by annual low-dose CT to monitor for new primary lung cancers.³

“Finishing curative-intent treatment is not the end of cancer care. As survival rates continue to improve and more people with a cancer diagnosis are living longer lives, survivorship care is increasingly important. That means proactive follow-up for recurrence, screening for new cancers and monitoring for long-term treatment effects,” said Gordon Downie, MD, PhD, Chief Medical Officer of bioAffinity Technologies.” CyPath Lung complements CT surveillance by providing actionable information that helps physicians evaluate new or changing pulmonary nodules identified by imaging.”

The potential role of CyPath Lung in recurrence surveillance builds on the test’s ability to analyze the lung microenvironment in real time. Drawing on three years of commercial experience, CyPath Lung has shown promising clinical performance in helping physicians stratify malignancy risk and guide patient management, including clinical case studies that illustrate how CyPath Lung helped clarify challenging cases in which imaging findings and predictive models alone produced uncertain or conflicting assessments.

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. These clinical performance data relate to CyPath Lung’s use in the detection setting and have not been separately validated for post-treatment surveillance. 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.

² https://jtd.amegroups.org/article/view/108627/html

³ DOI: 10.1200/JOP.19.00722

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 expand CyPath Lung into new clinical applications including post-treatment surveillance, the availability and adequacy of clinical data to support new use cases, 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

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

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