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

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bioAffinity Technologies reported that the Australian Patent Office has accepted its patent application AU 2019253111, titled “System and Method for Determining Lung Health.” The patent covers methods that combine flow cytometry with fluorescent probes and molecular tags that attach to specific cell types to detect cellular and molecular signatures of multiple lung diseases. The company issued a press release, attached as Exhibit 99.1.

bioAffinity Technologies ha riferito che l'Ufficio Australiano dei Brevetti ha accettato la sua domanda di brevetto AU 2019253111, intitolata “Sistema e metodo per determinare la salute dei polmoni.” Il brevetto copre metodi che combinano citometria a flusso con sonde fluorescenti e tag molecolari che si legano a specifici tipi di cellule per rilevare firme cellulari e molecolari di molte malattie polmonari. L'azienda ha emesso un comunicato stampa, allegato come Allegato 99.1.

bioAffinity Technologies informó que la Oficina de Patentes de Australia ha aceptado su solicitud de patente AU 2019253111, titulada “Sistema y método para determinar la salud de los pulmones.” La patente cubre métodos que combinan citometría de flujo con sondas fluorescentes y etiquetas moleculares que se adhieren a tipos celulares específicos para detectar firmas celulares y moleculares de múltiples enfermedades pulmonares. La empresa emitió un comunicado de prensa, adjunto como el Anexo 99.1.

bioAffinity Technologies는 호주 특허청이 AU 2019253111호 특허 출원을 수용했다고 발표했다. 특허의 제목은 “폐 건강 판단 시스템 및 방법”이다. 특허는 흐름 세포측정(유세포분석)과 형광 프로브 및 특정 세포 유형에 부착되는 분자 태그를 결합한 방법을 다루며, 여러 폐 질환의 세포 및 분자 서명을 탐지한다. 회사는 보도자료를 발표했고, Exhibit 99.1로 첨부되어 있다.

bioAffinity Technologies a signalé que l’Office australien des brevets a accepté sa demande de brevet AU 2019253111, intitulée « Système et méthode pour déterminer la santé des poumons ». Le brevet couvre des méthodes qui combinent la cytométrie en flux avec des sondes fluorescentes et des étiquettes moléculaires qui se fixent à des types cellulaires spécifiques pour détecter les signatures cellulaires et moléculaires de multiples maladies pulmonaires. L’entreprise a publié un communiqué de presse, joint en tant qu’annexe 99.1.

bioAffinity Technologies berichtete, dass das Australian Patent Office seine Patentanmeldung AU 2019253111 mit dem Titel „System und Verfahren zur Bestimmung der Lungengesundheit“ akzeptiert hat. Das Patent deckt Methoden ab, die Durchflusszytometrie mit fluoreszierenden Sonden und Molekül-Tags kombinieren, die an spezifische Zelltypen binden, um zelluläre und molekulare Signaturen mehrerer Lungenerkrankungen zu erkennen. Das Unternehmen hat eine Pressemitteilung veröffentlicht, die als Anhang 99.1 beigefügt ist.

bioAffinity Technologies ذكرت أن مكتب براءات الاختراع الأسترالي قد قبل طلب براءة الاختراع AU 2019253111، بعنوان “نظام وطريقة لتحديد صحة الرئة.” تغطي البراءة الطرق التي تجمع بين قياس التدفق الخلوي مع مجسات فلورية وأوسمة جزيئية ترتبط بأنواع خلايا محددة للكشف عن التوقيعات الخلوية والجزيئية لعدة أمراض رئوية. أصدرت الشركة بياناً صحفياً، مرفق كالملاحظة 99.1.

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bioAffinity Technologies ha riferito che l'Ufficio Australiano dei Brevetti ha accettato la sua domanda di brevetto AU 2019253111, intitolata “Sistema e metodo per determinare la salute dei polmoni.” Il brevetto copre metodi che combinano citometria a flusso con sonde fluorescenti e tag molecolari che si legano a specifici tipi di cellule per rilevare firme cellulari e molecolari di molte malattie polmonari. L'azienda ha emesso un comunicato stampa, allegato come Allegato 99.1.

bioAffinity Technologies informó que la Oficina de Patentes de Australia ha aceptado su solicitud de patente AU 2019253111, titulada “Sistema y método para determinar la salud de los pulmones.” La patente cubre métodos que combinan citometría de flujo con sondas fluorescentes y etiquetas moleculares que se adhieren a tipos celulares específicos para detectar firmas celulares y moleculares de múltiples enfermedades pulmonares. La empresa emitió un comunicado de prensa, adjunto como el Anexo 99.1.

bioAffinity Technologies는 호주 특허청이 AU 2019253111호 특허 출원을 수용했다고 발표했다. 특허의 제목은 “폐 건강 판단 시스템 및 방법”이다. 특허는 흐름 세포측정(유세포분석)과 형광 프로브 및 특정 세포 유형에 부착되는 분자 태그를 결합한 방법을 다루며, 여러 폐 질환의 세포 및 분자 서명을 탐지한다. 회사는 보도자료를 발표했고, Exhibit 99.1로 첨부되어 있다.

bioAffinity Technologies a signalé que l’Office australien des brevets a accepté sa demande de brevet AU 2019253111, intitulée « Système et méthode pour déterminer la santé des poumons ». Le brevet couvre des méthodes qui combinent la cytométrie en flux avec des sondes fluorescentes et des étiquettes moléculaires qui se fixent à des types cellulaires spécifiques pour détecter les signatures cellulaires et moléculaires de multiples maladies pulmonaires. L’entreprise a publié un communiqué de presse, joint en tant qu’annexe 99.1.

bioAffinity Technologies berichtete, dass das Australian Patent Office seine Patentanmeldung AU 2019253111 mit dem Titel „System und Verfahren zur Bestimmung der Lungengesundheit“ akzeptiert hat. Das Patent deckt Methoden ab, die Durchflusszytometrie mit fluoreszierenden Sonden und Molekül-Tags kombinieren, die an spezifische Zelltypen binden, um zelluläre und molekulare Signaturen mehrerer Lungenerkrankungen zu erkennen. Das Unternehmen hat eine Pressemitteilung veröffentlicht, die als Anhang 99.1 beigefügt ist.

bioAffinity Technologies ذكرت أن مكتب براءات الاختراع الأسترالي قد قبل طلب براءة الاختراع AU 2019253111، بعنوان “نظام وطريقة لتحديد صحة الرئة.” تغطي البراءة الطرق التي تجمع بين قياس التدفق الخلوي مع مجسات فلورية وأوسمة جزيئية ترتبط بأنواع خلايا محددة للكشف عن التوقيعات الخلوية والجزيئية لعدة أمراض رئوية. أصدرت الشركة بياناً صحفياً، مرفق كالملاحظة 99.1.

bioAffinity Technologies 报告称澳大利亚专利局已接受其专利申请 AU 2019253111,题为“用于确定肺部健康的系统与方法。” 该专利涵盖将流式细胞术与荧光探针及能够附着到特定细胞类型的分子标签结合起来,用以检测多种肺部疾病的细胞和分子特征的方法。公司已发布新闻稿,作为附件 99.1 附上。

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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 28, 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 28, 2025, bioAffinity Technologies, Inc., a Delaware corporation, issued a press release announcing that the Australian Patent office has accepted its patent application AU 2019253111 titled “System and Method for Determining Lung Health,” which covers methods that use flow cytometry combined with fluorescent probes, molecular tags that attach to specific cell types, to detect cellular and molecular signatures of multiple lung diseases.

 

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 28, 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 28, 2025 BIOAFFINITY TECHNOLOGIES, INC.
   
  By: /s/ Maria Zannes
  Name: Maria Zannes
  Title: President and Chief Executive Officer

 

-3-

 

FAQ

What did BIAF announce in its 8-K?

The company announced Australian Patent Office acceptance of patent application AU 2019253111 for a system and method to determine lung health.

Which technologies are covered by the accepted patent for BIAF?

It covers methods using flow cytometry with fluorescent probes and molecular tags targeting specific cell types.

What conditions does the BIAF patent aim to address?

It targets detection of cellular and molecular signatures of multiple lung diseases.

What is the title of BIAF’s accepted Australian patent application?

The title is “System and Method for Determining Lung Health.”

When did BIAF announce the Australian patent acceptance?

The announcement was made on October 28, 2025.

Where can investors find more details on BIAF’s patent news?

See the company’s press release attached as Exhibit 99.1.
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