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重大事件 即時報告 8-K 2026-07-22

bioAffinity Technologies與Pictor合作開發哮喘及COPD診斷測試,瞄準逾千億美元市場

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AI 繁中摘要

bioAffinity Technologies(納斯達克:BIAF;BIAFW)與Pictor, Inc. 達成合作,共同開發及商業化針對哮喘和慢性阻塞性肺病(COPD)的下一代診斷測試 🧪。該合作將bioAffinity在流式細胞術的專長與Pictor的定向蛋白質組學分析平台結合,旨在提高化驗室吞吐量、降低營運成本,並為全球超過6.5億患者提供更個人化的治療方案。 根據Grand View Research數據,全球哮喘和COPD治療市場在2024年約為920億美元,預計2026年將超過1,080億美元,2030年更達1,550億美元,增長動力來自標靶療法和生物製劑的廣泛應用。兩家公司開發的測試透過分析痰液中的免疫細胞族群及細胞因子譜,幫助醫生識別患者發炎的具體生物途徑,從而匹配更有效的治療,包括FDA已批准的生物製劑。 bioAffinity總裁兼CEO Maria Zannes表示,Pictor平台能顯著提升實驗室效率,以服務這個龐大且快速增長的市場。首席醫學官Gordon Downie博士強調,哮喘和COPD並非單一疾病,而是涉及多種發炎路徑,新診斷工具旨在實現真正的精準醫學。 根據協議,bioAffinity將保留與測試相關的知識產權,Pictor則保留其平台原有IP及新發明。測試初期將以實驗室開發測試(LDT)形式,在CLIA認證實驗室推出。Pictor CEO Jamie Platt博士(同時自2023年起擔任bioAffinity董事)表示,合作將超越單純疾病識別,深入理解每位患者的生物學基礎,推動更有效的治療。 對投資者而言,此合作有助bioAffinity將CyPath® Lung的技術平台延伸至哮喘和COPD領域,開拓更大的市場機會。然而,公司提醒此為前瞻性陳述,實際結果可能因監管變化、資金需求、知識產權保護等因素而異,詳情請參閱公司提交SEC的10-K及後續文件。
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Exhibit
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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.

 

 

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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

[email protected]

 

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