BIAF announces USPTO notice of allowance for sputum-based test patent

Rhea-AI Filing Summary

bioAffinity Technologies (BIAF) reported a regulatory milestone. The company received a notification of allowance from the U.S. Patent and Trademark Office for a patent titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.” The patent covers a system and method for predicting the likelihood of lung cancer by analyzing patient sputum samples.

The company disclosed the news in a Form 8-K under Item 8.01 and attached a related press release as Exhibit 99.1. A notification of allowance indicates the USPTO intends to grant the patent following completion of administrative steps.

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, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

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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): October 16, 2025

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 October 16, 2025, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that it has received a notification of allowance from the United States Patent and Trademark Office for a new patent titled “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning,” which covers a system and method for predicting the likelihood of lung cancer by analyzing patient sputum samples.

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 October 16, 2025
104		Cover Page Interactive Data File (embedded within the XBRL document)

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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: October 16, 2025	BIOAFFINITY TECHNOLOGIES, INC.
	By:	/s/ Maria Zannes
	Name:	Maria Zannes
	Title:	President and Chief Executive Officer

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FAQ

What did bioAffinity Technologies (BIAF) announce?

The company received a USPTO notification of allowance for a patent covering a system and method to predict lung cancer likelihood from sputum samples.

What is the patent title mentioned by BIAF?

“Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.”

When was the announcement made by BIAF?

The company reported it on October 16, 2025.

What technology does the patent cover?

It covers analyzing patient sputum using automated flow cytometry and machine learning to predict lung cancer likelihood.

Where can I find more details in the filing?

A press release is attached as Exhibit 99.1 to the Form 8-K.