bioAffinity Technologies Announces Notification of Allowance for U.S. Patent Application for Its Diagnostic Algorithm and Test Method for Lung Cancer

On October 16, 2025 bioAffinity Technologies, Inc. (Nasdaq: BIAF; BIAFW), a biotechnology company advancing early-stage cancer diagnostics including CyPath Lung, the Company’s commercially available test for early-stage lung cancer, reported it has received a notification of allowance from the United States Patent and Trademark Office (USPTO) for a new patent covering the AI-built algorithm and flow cytometry platform that analyzes cell populations in sputum leading to detection of lung cancer.

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"Artificial intelligence was integral to the development of our CyPath Lung test and has resulted in the detection of lung cancer at its earliest Stage 1A, a potentially curative stage," said Maria Zannes, President and CEO of bioAffinity Technologies. "A quarter of a million Americans are expected to receive a lung cancer diagnosis in 2025, representing the leading cause of cancer death. Harnessing AI with our novel flow cytometry platform has resulted in a diagnostic that produces high-precision, standardized, data-driven results."

The patent, titled "Detection of Early-Stage Lung Cancer in Sputum using Automated Flow Cytometry and Machine Learning," covers a system and method for predicting the likelihood of lung cancer by analyzing patient sputum samples. CyPath Lung’s advanced flow cytometry process detects changes in the lung linked to cancer, including populations of immune cells, apoptotic cells and cancer and cancer-related cells labeled by the Company’s proprietary TCPP porphyrin. CyPath Lung’s AI-driven analysis combines these variables with patient age to predict cancer in the lung.

CyPath Lung can be utilized by physicians to determine next steps for patients with pulmonary nodules requiring follow-up. The noninvasive test is designed to perform with high sensitivity and specificity and seeks to deliver valuable diagnostic insight while alleviating patient anxiety, preventing unnecessary invasive procedures and reducing costs to the healthcare system.

This newly allowed U.S. patent complements bioAffinity’s expanding global patent estate, which now includes 18 awarded and 33 pending patents. bioAffinity Technologies holds patents in the U.S., Canada, China, France, Germany, Hong Kong, Italy, Japan, Mexico, Spain, Sweden, and the United Kingdom.

About CyPath Lung

CyPath Lung uses proprietary advanced flow cytometry and artificial intelligence (AI) to identify cell populations in patient sputum that indicate malignancy. Automated data analysis helps determine if cancer is present or if the patient is cancer-free. CyPath Lung incorporates a fluorescent porphyrin that is preferentially taken up by cancer and cancer-related cells. Clinical study results demonstrated that CyPath Lung had 92% sensitivity, 87% specificity and 88% accuracy in detecting lung cancer in patients at high risk for the disease who had small lung nodules less than 20 millimeters. Diagnosing and treating early-stage lung cancer can improve outcomes and increase patient survival. For more information, visit www.cypathlung.com.

(Press release, BioAffinity Technologies, OCT 16, 2025, View Source [SID1234656722])

Tempus Announces Collaboration with Whitehawk Therapeutics to Advance Biomarker-Driven Oncology Research

On October 16, 2025 Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine, reported a multi-year collaboration with Whitehawk Therapeutics, Inc. (NASDAQ: WHWK), an oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugates (ADC) cancer treatments. The collaboration aims to leverage Tempus’ proprietary real-world dataset to advance biomarker-driven research and support the development of Whitehawk Therapeutics’ oncology pipeline.

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Under the agreement, Whitehawk Therapeutics will apply Tempus’ de-identified multimodal database to support the biotech’s clinical trial designs by focusing on the right patient population(s) with the highest level of demonstrated real-world unmet need. The collaboration will center on powering research spanning Whitehawk Therapeutics’ ADC portfolio, which includes three assets designed to target clinically validated proteins (PTK7, MUC16 and SEZ6) that are broadly expressed in high-potential cancer indications, such as lung and gynecological cancers.

"Tempus’ comprehensive, multimodal data, paired with Whitehawk’s ADC drug development expertise, create a powerful foundation to validate the potential of their portfolio in a promising class of targeted cancer therapeutics," said Ryan Fukushima, Chief Operating Officer at Tempus. "We’re committed to working in tandem with our biotech collaborators to uncover actionable insights from our AI platform so they can make smarter, faster decisions throughout the drug development process."

"A proactive approach to our biomarker strategy ensures our programs are guided by data-driven insights," said Dave Lennon, PhD, President and CEO, Whitehawk Therapeutics. "By partnering with Tempus, our goal is to better understand the expression of our ADC protein targets to inform indication prioritization for our clinical development programs and better exploit the full potential of our pipeline. An important aspect of this partnership will be continuing to establish the concordance between RNA and IHC expression of our targets. Because RNA testing is objective, reproducible and scalable, establishing it as a reliable alternative to the more subjective IHC methods could enhance our ability to readily identify appropriate patients for our ADC therapies."

(Press release, Tempus, OCT 16, 2025, View Source [SID1234656721])

Personalis Announces New Data from a Landmark Lung Cancer Trial Utilizing Ultrasensitive MRD Testing

On October 16, 2025 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal, is a useful tool in assessing the maintenance treatment response post-CRT in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).

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The new LAURA analysis will be presented at the ESMO (Free ESMO Whitepaper) 2025 Conference in Berlin, Germany, demonstrating key findings for NeXT Personal:

Treatment monitoring: Osimertinib treatment led to MRD clearance in most patients with post-chemoradiotherapy (post-CRT) MRD, demonstrating the utility of ctDNA for monitoring the maintenance therapy response
Lead time to progression: NeXT Personal detected MRD progression with a median lead time of 5 months ahead of Blinded Independent Central Review (BICR) assessed disease progression
"This study from AstraZeneca shows how ultrasensitive ctDNA detection enabled by NeXT Personal enables precise tracking of the maintenance treatment response post-CRT during clinical trials. It is a good example of how AstraZeneca and our other biopharma partners are taking advantage of our ultrasensitive assay to gain new insights into their clinical studies," said Richard Chen, Chief Medical Officer and EVP of R&D at Personalis.

The LAURA trial (NCT03521154) is a global, randomized, placebo-controlled, double-blind, multi-center study of osimertinib following chemoradiation for patients with unresectable EGFRm NSCLC.

This collaboration also builds on previous work with AstraZeneca, showing the importance of highly sensitive ctDNA analysis for tracking treatment response and predicting cancer recurrence. This includes a recent publication of Phase 3 CALLA cervical cancer study results showing that NeXT Personal detected traces of cancer DNA in patients with locally advanced cervical cancer up to ~16 months ahead of standard of care imaging, and a recent presentation at the IASLC 2025 World Conference on Lung Cancer on the NeoADAURA study demonstrating that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting.

(Press release, Personalis, OCT 16, 2025, View Source [SID1234656720])

Techsomed and Medtronic to Collaborate on Image Guided Ablation Therapy

On October 16, 2025 Techsomed Ltd., a pioneering medical AI-powered software company specializing in image-guided therapy reported a collaboration with Medtronic, a global leader in healthcare technology. The pilot collaboration brings together Techsomed’s BioTraceIO360 software and the Medtronic Emprint microwave ablation system as a complete solution for Image Guided Ablation Therapy. Together, Techsomed and Medtronic can support interventional radiologists (IRs) throughout the full cycle of ablation management, from planning to post-treatment assessment.

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In minimally invasive therapies such as ablation, effective image guidance is crucial. However, challenges such as limited intra-procedural visibility, non-integrated technologies, and reliance on fragmented imaging systems can hinder physicians’ ability to maintain local control of tumor margins, often leading to the need for repeat interventions.

By using Techsomed’s innovative planning, visualization, and margin confirmation software in combination with the Emprint Ablation System with Thermosphere technology, IRs will arm themselves with advanced capabilities for real-time visualization, predictive margin control, dynamic treatment planning, and scalable, spherical ablation zones, allowing them to pursue optimal treatment outcomes.

"In collaboration with Medtronic, we aim to set a new standard for minimally invasive ablation treatment—grounded in data, not assumptions," said Yossi Abu, CEO and Founder of Techsomed. "By adding our advanced imaging, real-time predictive modeling, and seamless workflow integration to the cutting-edge ablation technology offered by Medtronic and their industry-leading in-vivo therapy datasets, we aspire to bring a new level of treatment precision to our customers."

(Press release, Medtronic, OCT 16, 2025, View Source [SID1234656718])

HARMONi-6 Phase III Study of Ivonescimab Accepted by The Lancet and Selected for ESMO 2025 LBA Presentation

On October 16, 2025 Akeso Inc. (9926.HK) reported that the groundbreaking results from the registrational Phase III AK112-306/HARMONi-6 study of ivonescimab have been accepted for publication in The Lancet. The study evaluated ivonescimab, a first-in-class PD-1/VEGF bispecific antibody, combined with chemotherapy versus tislelizumab plus chemotherapy as first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). The article of Lancet will be simultaneously published during the 2025 European Society for Medical Oncology (2025 ESMO (Free ESMO Whitepaper)) Congress.

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The HARMONi-6 trial result has been selected as a Late-Breaking Abstract (LBA) for the 2025 ESMO (Free ESMO Whitepaper) Congress. Professor Lu Shun, Director of the Oncology Department at Shanghai Chest Hospital, presented the study’s findings at the Presidential Symposium. The results of this study extend Akeso’s leadership in immunotherapy 2.0 and promise to shape future clinical strategies.

The HARMONi-6 trial marks a significant advancement for ivonescimab following its success in the head-to-head study against pembrolizumab as first-line treatment for PD-L1-positive NSCLC. This Phase III study has now demonstrated positive outcomes in a comparison of ivonescimab plus chemotherapy versus PD-1 inhibitor plus chemotherapy for the first-line treatment of squamous NSCLC, addressing a key unmet need in the treatment for advanced squamous NSCLC using anti-angiogenic agents. These successful outcomes demonstrate that ivonescimab achieves significant clinical breakthroughs, not only in comparison to PD-1 monotherapy or PD-1 combination chemotherapy, the current standard of care for many cancers in the immuno-oncology field, but also against VEGF-targeted therapies in anti-angiogenesis.

The encouraging results from the HARMONi-6 study have led to the review of a supplemental New Drug Application (sNDA) in China for ivonescimab in combination with chemotherapy as a first-line treatment for advanced squamous NSCLC.

(Press release, Akeso Biopharma, OCT 16, 2025, View Source [SID1234656717])