STOCK TITAN

bioAffinity Technologies (Nasdaq: BIAF) teams with Pictor on lung inflammation diagnostics

(High)
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

bioAffinity Technologies, Inc. announced a collaboration with Pictor, Inc. to develop and commercialize next-generation diagnostic tests that profile lung inflammation in asthma and COPD by combining bioAffinity’s sputum-based flow cytometry with Pictor’s targeted proteomic platform to analyze immune cell populations and cytokine patterns.

The partners plan to initially offer these diagnostics as Laboratory Developed Tests under CLIA, with bioAffinity owning intellectual property for tests arising from the collaboration and Pictor retaining and expanding IP around its proteomic platform. Asthma and COPD affect more than 40 million Americans and 650 million people worldwide, and the global therapeutics market was valued at approximately $92 billion in 2024 and is projected to exceed $108 billion in 2026 and $155 billion by 2030, illustrating a large potential addressable market. The company notes forward-looking risks related to product development, regulatory changes for LDTs, intellectual property protection, financing needs and realization of anticipated collaboration benefits.

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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.
Americans with asthma and COPD More than 40 million Americans Population affected by asthma and COPD cited as potential diagnostics market
Global asthma and COPD patients More than 650 million people worldwide Worldwide population affected by asthma and COPD
Global therapeutics market 2024 Approximately $92 billion Value of global asthma and COPD therapeutics market in 2024
Projected market 2026 Exceed $108 billion in 2026 Projected global asthma and COPD therapeutics market size
Projected market 2030 $155 billion by 2030 Projected global asthma and COPD therapeutics market size
Pictor IP portfolio 16 patents, five pending, seven registered trademarks Scope of Pictor’s intellectual property cited in collaboration announcement
Laboratory Developed Tests (LDTs) regulatory
"tests under development will initially be offered as Laboratory Developed Tests (LDTs) under the CLIA"
Laboratory developed tests (LDTs) are diagnostic tests created, validated and performed within a single clinical laboratory rather than bought as a finished product from a manufacturer; think of a chef developing a custom recipe in their own kitchen instead of serving a store-bought dish. Investors watch LDTs because they can be a steady source of revenue and competitive advantage for labs, but they also carry regulatory, reimbursement and liability risks that can quickly affect a lab’s earnings and valuation.
Clinical Laboratory Improvement Amendments (CLIA) regulatory
"LDTs are overseen under the Clinical Laboratory Improvement Amendments (CLIA), administered by CMS"
Clinical Laboratory Improvement Amendments (CLIA) are U.S. federal rules that set minimum quality and safety standards for medical laboratories that test human samples, covering test accuracy, staff qualifications, equipment, recordkeeping and routine inspections. For investors, CLIA acts like a regulatory "health inspection" for labs: certification is often required to legally run and sell clinical tests, so it directly affects a lab’s ability to generate revenue, enter markets and avoid regulatory risk.
targeted proteomic platform technical
"Pictor®, Inc., a targeted proteomic platform company, to support development and commercialization"
A targeted proteomic platform is a laboratory system that measures specific proteins in biological samples using focused assays and software, often built around mass spectrometry or validated antibody tests. Think of it as a set of precise measuring tools tuned to a few important parts rather than scanning everything; it matters to investors because it produces repeatable, quantitative biomarker data that can support drug development, diagnostics, performance claims, regulatory filings, and commercial opportunities.
flow cytometry technical
"integrate bioAffinity’s expertise in flow cytometry with Pictor’s targeted proteomic analysis platform"
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.
cytokines medical
"platform rapidly analyzes the inflammatory proteins, or cytokines, produced by those immune cells"
Small proteins produced by immune and other cells that act as on/off signals or “text messages,” telling cells to ramp up, calm down, grow, or move during infection, injury, or disease. Investors watch cytokines because they are common drug targets and biomarkers—changes in cytokine activity can make a therapy work, cause serious side effects, or determine clinical trial and regulatory outcomes, all of which affect a company’s value.
precision medicine medical
"new diagnostics are designed to advance precision medicine in asthma and COPD"
Precision medicine uses a person’s unique genetic makeup, lifestyle and environment to choose treatments and preventive steps that are more likely to work for them than one-size-fits-all approaches. For investors, it matters because it can make therapies more effective and efficient—think tailoring a suit rather than buying off the rack—affecting drug development costs, market size, pricing power and the speed at which therapies win regulatory approval.

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FAQ

What collaboration did bioAffinity Technologies (BIAF) announce with Pictor?

bioAffinity Technologies (BIAF) announced a collaboration with Pictor, Inc. to develop and commercialize next-generation diagnostic tests for asthma and COPD. The partnership integrates bioAffinity’s flow cytometry of sputum samples with Pictor’s targeted proteomic platform to characterize lung inflammation and support more personalized treatment decisions.

How will the new bioAffinity (BIAF) and Pictor asthma and COPD tests work?

The tests under development will combine sputum-based flow cytometry to differentiate immune cell populations with Pictor’s platform to profile cytokines linked to airway inflammation. This high-throughput approach is intended to reveal inflammatory pathways and help physicians match patients with targeted and biologic therapies.

What market opportunity does bioAffinity (BIAF) highlight for asthma and COPD diagnostics?

bioAffinity (BIAF) notes that asthma and COPD affect more than 40 million Americans and over 650 million people worldwide. It cites a global asthma and COPD therapeutics market valued at about $92 billion in 2024, projected to exceed $108 billion in 2026 and $155 billion by 2030.

How is intellectual property allocated in the bioAffinity (BIAF)–Pictor collaboration?

bioAffinity (BIAF) states it has multiple patents pending on its asthma and COPD testing platform and will own IP associated with tests that result from the collaboration. Pictor retains its existing IP and will own new inventions related to its targeted proteomic platform technology.

What regulatory pathway is planned for bioAffinity (BIAF) asthma and COPD diagnostics?

bioAffinity (BIAF) anticipates the new asthma and COPD tests will initially be offered as Laboratory Developed Tests (LDTs) under the Clinical Laboratory Improvement Amendments (CLIA). LDTs are overseen by the Centers for Medicare & Medicaid Services, and the company notes an evolving regulatory landscape for such tests.

What key risks does bioAffinity (BIAF) identify for its asthma and COPD test development?

bioAffinity (BIAF) highlights risks including its ability to successfully develop and commercialize the tests, potential that the Pictor collaboration may not deliver anticipated benefits, changing LDT regulations, maintaining adequate IP protection, the need for additional capital, and uncertainties in third-party market estimates.

How does the new collaboration relate to bioAffinity (BIAF)’s existing CyPath Lung test?

The asthma and COPD diagnostics build on bioAffinity (BIAF)’s proprietary sputum analysis platform, the same scientific approach used in CyPath Lung, its noninvasive test that helps assess the likelihood a pulmonary nodule is malignant. The new tests extend this platform into inflammatory profiling for chronic airway diseases.
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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): July 22, 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 July 22, 2026, bioAffinity Technologies, Inc., a Delaware corporation (the “Company”), issued a press release announcing a collaboration with Pictor, Inc., a targeted proteomic platform company, to support development and commercialization of the Company’s next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and chronic obstructive pulmonary disease (COPD).

 

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 July 22, 2026
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: July 22, 2026 BIOAFFINITY TECHNOLOGIES, INC.
   
   
  By: /s/ Maria Zannes
  Name: Maria Zannes
  Title: President and Chief Executive Officer

 

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Exhibit 99.1

 

     

 

bioAffinity Technologies and Pictor®, Inc. Partner to Develop and Commercialize bioAffinity’s Diagnostics for Asthma and COPD

 

Collaboration increases laboratory throughput and reduces costs for personalized testing for asthma and COPD, which affect more than 40 million Americans and 650 million people worldwide

 

Global asthma and COPD therapeutics market projected to exceed $108 billion in 2026 and $155 billion by 2030, driven by increasing use of targeted therapies and biologics

 

Tests under development are intended to help match asthma and COPD patients with more effective and personalized treatments targeting their specific inflammatory profile

 

SAN ANTONIO, Texas – July 22, 2026 – bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics and targeted therapeutics, today announced a collaboration with Pictor®, Inc., a targeted proteomic platform company, to support development and commercialization of bioAffinity Technologies’ next-generation diagnostic tests designed to provide a more complete picture of lung inflammation in patients with asthma and chronic obstructive pulmonary disease (COPD).

 

The agreement will integrate bioAffinity’s expertise in flow cytometry with Pictor’s targeted proteomic analysis platform to analyze immune cell populations and cytokine profiles associated with airway inflammation.

 

“Pictor’s targeted proteomic platform has the ability to lower our operating costs compared with traditional single-analyte testing by improving laboratory efficiency and reducing testing complexity, all of which is required to serve a large and growing market like that of asthma and COPD,” said Maria Zannes, President and CEO of bioAffinity Technologies. “We look forward to taking advantage of Pictor’s expertise in proteomics and product development, and their team’s experience in optimizing laboratory-friendly workflows to facilitate high throughput testing.”

 

bioAffinity has multiple patents pending for its inventions related to its asthma and COPD testing platform and will own the intellectual property associated with the tests that may emanate from the collaboration. Pictor retains its existing intellectual property and will own new inventions related to its targeted proteomic platform technology.

 

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The tests under development build on bioAffinity’s proprietary approach to interrogating the lung microenvironment through sputum analysis, the same scientific platform that powers CyPath® Lung, the Company’s commercially available noninvasive test that helps physicians assess the likelihood that a pulmonary nodule is malignant. The Company anticipates that the tests under development will initially be offered as Laboratory Developed Tests (LDTs) under the Clinical Laboratory Improvement Amendments (CLIA).

 

“Asthma and COPD are not single diseases. They encompass multiple inflammatory pathways that require different therapeutic approaches,” said Gordon Downie, MD, PhD, bioAffinity’s Chief Medical Officer. “By measuring immune cell populations using flow cytometry and integrating Pictor’s cytokine profiling platform into its test protocol, our new diagnostics are designed to advance precision medicine in asthma and COPD by providing physicians with a more complete understanding of the biological processes driving airway inflammation in real time.”

 

bioAffinity Technologies’ flow cytometry platform differentiates and quantifies immune cell populations in sputum while Pictor’s proteomic platform rapidly analyzes the inflammatory proteins, or cytokines, produced by those immune cells. The anticipated result is a high-throughput laboratory test for bioAffinity Technologies that is intended to help physicians identify the inflammatory pathways driving an individual patient’s disease and support more informed decisions when considering advanced therapies, including FDA-approved biologics and emerging targeted treatments.

 

According to the Centers for Disease Control, asthma and COPD affect more than 40 million Americans and more than 650 million people worldwide, representing a significant potential market for precision diagnostic tools that provide deeper insights into each patient’s disease and help advance personalized treatment. The global asthma and COPD therapeutics market was valued at approximately $92 billion in 2024 and is projected to exceed $108 billion in 2026 and $155 billion by 20301, driven by increasing use of targeted therapies and biologics.

 

Pictor, Inc. is led by CEO and Managing Director Jamie Platt, PhD, a recognized diagnostics executive who joined bioAffinity Technologies’ Board of Directors in 2023. Prior to her work with Pictor, Dr. Platt helped lead two successful diagnostic company acquisitions valued collectively at nearly $1 billion. Since opening its U.S. headquarters in 2025, Pictor has expanded adoption of its targeted proteomic platform through strategic partnerships across pharmaceutical, laboratory, and research markets.

 

 

1 https://www.grandviewresearch.com/industry-analysis/copd-asthma-therapeutics-market-report

 

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“We’re excited to partner with bioAffinity Technologies as they continue to develop innovative, non-invasive tests for lung disease,” said Dr. Jamie Platt, CEO of Pictor. “By combining bioAffinity’s expertise in immune cell biology with Pictor’s scalable proteomic platform, we can advance bioAffinity’s ability to provide insights that move beyond simply identifying disease to understanding the underlying biology of each patient’s condition, leading to more effective treatments.”

 

Cytokines are small proteins produced by immune and other cells that bind to specific cell receptors to regulate immune responses, inflammation and cell growth. Different patterns of cytokines are associated with different types of asthma and COPD, and many FDA-approved biologic therapies are designed to target specific cytokines or their cellular receptors.

 

About Pictor, Inc.

 

Pictor, Inc. is a global targeted proteomic platform company founded in New Zealand and headquartered in Carlsbad, California, with operations in New Zealand, Australia, and India. Pictor’s platform combines PictArray®, PictImager®, and Pictorial© software to support focused, multi-analyte protein analysis for human and animal health research environments. The company works with laboratories, biopharma companies, and other commercial partners to support development of targeted proteomic assays with efficient workflows designed to fit existing laboratory operations. Pictor’s IP portfolio includes 16 patents, five pending, and seven registered trademarks. For more information, visit www.pictorproteomics.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 in clinical studies published in peer-reviewed scientific journals. 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 develop and commercialize its diagnostic tests for asthma and COPD; the risk that the collaboration with Pictor may not achieve its anticipated benefits or may be terminated; the evolving regulatory landscape for laboratory developed tests, including potential requirements for FDA clearance or approval; the Company’s ability to obtain and maintain adequate intellectual property protection; the Company’s need for additional capital and its ability to obtain financing; the risk that third-party market estimates cited herein may not reflect actual market conditions; the Company’s limited operating history and history of losses; and the 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

 

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Filing Exhibits & Attachments

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