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[8-K] bioAffinity Technologies, Inc. Reports Material Event

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(Neutral)
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(Neutral)
Form Type
8-K

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.

bioAffinity Technologies (BIAF) ha riportato una tappa regolamentare. L'azienda ha ricevuto una notificazione di ammissione dall'U.S. Patent and Trademark Office per un brevetto intitolato “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.” Il brevetto copre un sistema e un metodo per prevedere la probabilità di cancro ai polmoni analizzando campioni di espettorato del paziente.

L'azienda ha reso nota la notizia in una Form 8-K sotto la voce Item 8.01 e ha allegato un relativo comunicato stampa come Exhibit 99.1. Una notificazione di ammissione indica che l'USPTO intende concedere il brevetto dopo il completamento dei passaggi amministrativi.

bioAffinity Technologies (BIAF) informó sobre un hito regulatorio. La empresa recibió una notificación de concesión de la Oficina de Patentes y Marcas de los Estados Unidos (USPTO) para una patente titulada “Detección de cáncer de pulmón en etapa temprana en esputo utilizando citometría de flujo automatizada y aprendizaje automático.” La patente abarca un sistema y un método para predecir la probabilidad de cáncer de pulmón mediante el análisis de muestras de esputo del paciente.

La empresa dio a conocer la noticia en un Formulario 8-K bajo el Artículo 8.01 y adjuntó un comunicado de prensa relacionado como Exhibit 99.1. Una notificación de concesión indica que la USPTO tiene la intención de conceder la patente tras completar los pasos administrativos.

bioAffinity Technologies (BIAF)가 규제상의 중요한 이정표를 발표했습니다. 이 회사는 미국 특허청(USPTO)으로부터 “Automated Flow Cytometry and Machine Learning을 사용한 가래에서 조기 단계의 폐암 탐지(Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning)”라는 제목의 특허에 대한 허가 통지를 받았습니다. 이 특허는 환자의 가래 샘플을 분석하여 폐암 가능성을 예측하는 시스템과 방법을 다룹니다.

회사는 이 소식을 Item 8.01 하의 Form 8-K에 공시했고 Exhibit 99.1로 관련 보도자료를 첨부했습니다. 허가 통지는 USPTO가 행정 절차를 마친 후 특허를 부여할 의도가 있음을 나타냅니다.

bioAffinity Technologies (BIAF) a annoncé une étape réglementaire. La société a reçu une notification d’autorisation de l’Office américain des brevets et des marques (USPTO) pour un brevet intitulé « Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning ». Le brevet couvre un système et une méthode permettant de prédire la probabilité de cancer du poumon en analysant des échantillons d’expectorations du patient.

La société a déclaré la nouvelle dans un Form 8-K sous l’Item 8.01 et a joint un communiqué de presse lié en tant qu’exhibit 99.1. Une notification d’autorisation indique que l’USPTO envisage d’accorder le brevet après l’achèvement des étapes administratives.

bioAffinity Technologies (BIAF) meldete einen regulatorischen Meilenstein. Das Unternehmen erhielt eine Zulassungsbenachrichtigung vom US-Patent- und Markenamt (USPTO) für ein Patent mit dem Titel „Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning“. Das Patent deckt ein System und ein Verfahren zur Vorhersage der Wahrscheinlichkeit von Lungenkrebs durch Analyse von Patientensputen ab.

Das Unternehmen machte die Nachricht in einem Form 8-K unter Item 8.01 öffentlich und fügte eine dazugehörige Pressemitteilung als Exhibit 99.1 bei. Eine Zulassungsbenachrichtigung bedeutet, dass das USPTO beabsichtigt, das Patent nach Abschluss der administrativen Schritte zu erteilen.

bioAffinity Technologies (BIAF) أبلغت عن محطة تنظيمية. تلقت الشركة إشعار قبول من مكتب الولايات المتحدة لبراءات الاختراع والعلامات التجارية (USPTO) لبِرَاءة بعنوان “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.” وتغطي البراءة نظاماً وطريقة لتوقع احتمال الإصابة بسرطان الرئة من خلال تحليل عينات البلغم للمريض.

كشفت الشركة عن الخبر في نموذج 8-K تحت البند 8.01 وأرفقت بياناً صحفياً ذا صلة كالمرفق 99.1. يشير إشعار القبول إلى أن USPTO يعتزم منح البراءة بعد إكمال الإجراءات الإدارية.

bioAffinity Technologies (BIAF) 报告了监管里程碑。公司已收到美国专利商标局(USPTO)关于题为“Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning”的专利的准予通知。该专利涵盖通过分析患者痰液样本来预测肺癌可能性的系统与方法。

公司在 Form 8-K 的 Item 8.01 下披露了此消息,并将相关的新闻稿作为 Exhibit 99.1 附件。准予通知意味着 USPTO 在完成行政步骤后打算授予该专利。

Positive
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Negative
  • None.

bioAffinity Technologies (BIAF) ha riportato una tappa regolamentare. L'azienda ha ricevuto una notificazione di ammissione dall'U.S. Patent and Trademark Office per un brevetto intitolato “Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning.” Il brevetto copre un sistema e un metodo per prevedere la probabilità di cancro ai polmoni analizzando campioni di espettorato del paziente.

L'azienda ha reso nota la notizia in una Form 8-K sotto la voce Item 8.01 e ha allegato un relativo comunicato stampa come Exhibit 99.1. Una notificazione di ammissione indica che l'USPTO intende concedere il brevetto dopo il completamento dei passaggi amministrativi.

bioAffinity Technologies (BIAF) informó sobre un hito regulatorio. La empresa recibió una notificación de concesión de la Oficina de Patentes y Marcas de los Estados Unidos (USPTO) para una patente titulada “Detección de cáncer de pulmón en etapa temprana en esputo utilizando citometría de flujo automatizada y aprendizaje automático.” La patente abarca un sistema y un método para predecir la probabilidad de cáncer de pulmón mediante el análisis de muestras de esputo del paciente.

La empresa dio a conocer la noticia en un Formulario 8-K bajo el Artículo 8.01 y adjuntó un comunicado de prensa relacionado como Exhibit 99.1. Una notificación de concesión indica que la USPTO tiene la intención de conceder la patente tras completar los pasos administrativos.

bioAffinity Technologies (BIAF)가 규제상의 중요한 이정표를 발표했습니다. 이 회사는 미국 특허청(USPTO)으로부터 “Automated Flow Cytometry and Machine Learning을 사용한 가래에서 조기 단계의 폐암 탐지(Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning)”라는 제목의 특허에 대한 허가 통지를 받았습니다. 이 특허는 환자의 가래 샘플을 분석하여 폐암 가능성을 예측하는 시스템과 방법을 다룹니다.

회사는 이 소식을 Item 8.01 하의 Form 8-K에 공시했고 Exhibit 99.1로 관련 보도자료를 첨부했습니다. 허가 통지는 USPTO가 행정 절차를 마친 후 특허를 부여할 의도가 있음을 나타냅니다.

bioAffinity Technologies (BIAF) a annoncé une étape réglementaire. La société a reçu une notification d’autorisation de l’Office américain des brevets et des marques (USPTO) pour un brevet intitulé « Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning ». Le brevet couvre un système et une méthode permettant de prédire la probabilité de cancer du poumon en analysant des échantillons d’expectorations du patient.

La société a déclaré la nouvelle dans un Form 8-K sous l’Item 8.01 et a joint un communiqué de presse lié en tant qu’exhibit 99.1. Une notification d’autorisation indique que l’USPTO envisage d’accorder le brevet après l’achèvement des étapes administratives.

bioAffinity Technologies (BIAF) meldete einen regulatorischen Meilenstein. Das Unternehmen erhielt eine Zulassungsbenachrichtigung vom US-Patent- und Markenamt (USPTO) für ein Patent mit dem Titel „Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning“. Das Patent deckt ein System und ein Verfahren zur Vorhersage der Wahrscheinlichkeit von Lungenkrebs durch Analyse von Patientensputen ab.

Das Unternehmen machte die Nachricht in einem Form 8-K unter Item 8.01 öffentlich und fügte eine dazugehörige Pressemitteilung als Exhibit 99.1 bei. Eine Zulassungsbenachrichtigung bedeutet, dass das USPTO beabsichtigt, das Patent nach Abschluss der administrativen Schritte zu erteilen.

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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)

 

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

 

-3-

 

 

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.
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