Form 8-K
8-K — bioAffinity Technologies, Inc.
Accession: 0001493152-26-049188
Filed: 2026-10-29
Period: 2026-10-29
CIK: 0001712762
SIC: 8731 (SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH)
Item: Other Events
Item: Financial Statements and Exhibits
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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 29, 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))
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 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 29, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing
that it will join physicians, patients and other healthcare providers at the Lung Cancer Initiative of North Carolina’s Battle
of the Blues that will highlight advancements in new diagnostics and therapies that are improving the lives of patients with lung cancer.
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 29, 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: October 29, 2026
BIOAFFINITY
TECHNOLOGIES, INC.
By:
/s/ Maria
Zannes
Name:
Maria Zannes
Title:
President and Chief
Executive Officer
-3-
EX-99.1
EX-99.1
Filename: ex99-1.htm · Sequence: 2
Exhibit
99.1
News
Release
bioAffinity
Technologies Highlights Importance of Link Between Early Lung Cancer Detection and Curative Treatment During National Lung Cancer Awareness
Month
Benefits
of CyPath® Lung to be shared with North Carolina patient advocacy and healthcare community at November 5 “Battle
of the Blues” Event
SAN
ANTONIO, Texas – October 29, 2026 – In recognition of National Lung Cancer Awareness Month, bioAffinity
Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company addressing the need for early lung cancer detection with its
noninvasive CyPath® Lung test, will join physicians, patients and other healthcare providers at the Lung Cancer Initiative
of North Carolina’s Battle of the Blues, an event that will highlight advancements in new diagnostics and therapies that
are improving the lives of patients with lung cancer.
The
Company will join others committed to advancing lung cancer awareness, research, and patient advocacy on November 5, 2026, at the event
where the results of major trials intended to change physician practice will be presented and providers
will learn of actionable thoracic oncology results that can enable them to improve treatment and care of lung cancer patients.
“During
National Lung Cancer Awareness Month, it is important to highlight the fact that lung cancer diagnosis and treatment is advancing at
a rapid pace. We are honored to be joining patient advocates and the dedicated physicians who play a crucial part in these advancements,”
said Maria Zannes, President and CEO of bioAffinity Technologies. “Early lung cancer detection can lead to curative therapy. Much
has changed – for the better – since my father died at age 39 of lung cancer. We are happy to be part of this good-news story.”
CyPath
Lung is a noninvasive, patent-protected assay that analyzes the lung microenvironment using advanced flow cytometry, AI-driven analysis,
and a proprietary combination of the fluorescent porphyrin TCPP and other biomarkers. The test characterizes cell populations in patient
sputum that indicate cancer may be present in the lung. CyPath Lung’s binary result of “Likely” or “Unlikely”
for malignancy gives physicians additional information to help assess lung cancer risk in patients with pulmonary nodules and guide decisions
about appropriate follow-up and care.
Using
CyPath Lung has the potential to diagnose lung cancer earlier when treatment is more effective. In multiple case studies, CyPath Lung
has detected lung cancer as early as curative Stage 1A. Decisions about follow-up and care should be based on the patient’s overall
clinical evaluation.
-1-
The
Lung Cancer Initiative of North Carolina’s Battle of the Blues brings together members of the lung cancer community to raise
awareness and support efforts to improve outcomes for people affected by lung cancer.
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 novel 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. The high NPV may help inform physician decision-making when evaluating whether further
invasive procedures are warranted. CyPath Lung is marketed as a Laboratory Developed Test (LDT), is not intended for use as a sole diagnostic
tool, and should be considered alongside other clinical findings. For more information, visit www.cypathlung.com.
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, including changes to the event’s schedule or the Company’s participation; the possibility that results cited
in case studies may not be replicated in broader populations or routine clinical practice; and the fact that earlier cancer detection
does not necessarily lead to improved patient outcomes. Additional risks and uncertainties are described 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
-2-
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