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New Publication Shows PROSTOX™ ultra Test Delivers Significant Health System Cost Savings and Quality-of-Life Gains for Prostate Cancer Patients Undergoing Radiation Therapy

On December 18, 2025 MiraDx, a molecular diagnostics company focused on germline genetic testing to personalize cancer treatment, reported a new analysis has been published in the Journal of Health Economics and Outcomes Research demonstrating that the PROSTOX ultra test can deliver substantial long-term economic and quality-of-life benefits for patients and the healthcare system.

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PROSTOX ultra is a clinically validated germline genetic test for men with localized prostate cancer considering stereotactic body radiation therapy (SBRT), a treatment that delivers high doses of radiation over a short time period, with 5-7 treatments. The test identifies patients at higher risk of developing late genitourinary (GU) toxicity—urinary side effects such as urgency, leakage, or discomfort that may occur after treatment. While SBRT is a very effective and convenient treatment for prostate cancer, a subset of patients experience urinary side effects that present months or even years after treatment and can persist throughout the patient’s lifetime. By identifying patients with increased risk of these side effects from SBRT, PROSTOX ultra helps doctors and patients make more informed treatment decisions and consider alternative options when needed.

The study, which modeled clinical pathways incorporating PROSTOX ultra versus treatment guided by the current standard of care for patients receiving treatment for localized prostate cancer, found a significant cost savings of $19,615 per tested patient. Over a lifetime, the benefits grow even larger. The analysis showed that each patient tested with PROSTOX ultra is expected to save the health care system approximately $24,777 over the patient’s lifetime, while also gaining 0.24 additional quality-adjusted life years (QALYs) compared to patients evaluated without genetic risk assessment.

The publication, "Economic Evaluation of a Novel MicroRNA-Based Assay to Determine Risk of Late Genitourinary Radiation Toxicity in Patients With Prostate Cancer," can be viewed in its entirety by visiting the Journal of Health Economics and Outcomes Research website here: View Source

"Physicians in practice using PROSTOX ultra are seeing its benefits in helping their patients avoid late GU toxicity from SBRT. These new results also now show that PROSTOX ultra meaningfully reduces the long-term cost burden on the healthcare system," said Melissa Stoppler, MD, Executive Vice President of Medical Affairs at MiraDx. "This new evidence further validates the value of integrating the test into treatment considerations for localized prostate cancer."

(Press release, MiraDx, DEC 18, 2025, View Source [SID1234661547])

Syneron Bio Closes Nearly $100M in Series A and A+ Rounds

On December 18, 2025 Syneron Bio, an macrocyclic peptide drug discovery company driven by intelligent high-throughput platform, reported it has successfully completed its Series A and A+ financing rounds, raising close to USD 100 million in total. Top-tier investors participated in the round, including AstraZeneca, AZ-CICC Healthcare Investment Fund, Pfizer Biotech Development Investment Fund, GL Ventures, 5Y Capital, Sinovation Capital, Lenovo Capital, Gree Capital and KHK fund.

Dr. Xiao Zhang, Founder and CEO of Syneron Bio, commented:
"We are honored to receive the recognition and support of leading global pharmaceutical companies and top-tier investment institutions. This financing will significantly strengthen the development of our intelligent high-throughput macrocyclic peptide development platform, Synova, and provide the resources needed to advance multiple pipelines toward clinical stages."

(Press release, Syneron Tech, DEC 18, 2025, View Source [SID1234661546])

Curasight Announces Successful Dosing of First Patient in Phase 1 trial with uTREAT® in Brain Cancer

On December 18, 2025 Curasight A/S ("Curasight" or "the Company" – TICKER: CURAS) reported the successful and safe dosing of the first patient in the Phase 1 trial using uTREAT in brain cancer (high grade gliomas). The news marks the initiation of the first clinical trial under the company’s therapeutic platform uTREAT, investigating it as a potential treatment option for glioblastoma.

The start of the phase 1 study with uTREAT means that Curasight is now in the clinical phase with both parts of its theranostic platform aimed at improving treatment and diagnosis of certain cancers. The company’s diagnostic platform uTRACE is currently in a Phase 2 trial for prostate cancer under the strategic partnership with Curium Inc.

"The dosing of the first patient with uTREAT in this Phase 1 trial marks an important step in the development of the therapeutic arm of our theranostic platform, making Curasight a clinical stage therapeutic company". Said Curasight’s CEO Ulrich Krasilnikoff. "I very much look forward to seeing the data and would like to take this opportunity to thank the patient and doctors involved in this trial in supporting our efforts to develop uTREAT ".

About the Phase 1 trial with uTREAT in brain cancer

The trial aims to investigate Curasight’s uTREAT as a new type of targeted radiopharmaceutical therapy in glioblastoma patients. Participants in the trial are patients with newly diagnosed verified or suspected GBM. The trial design is informed from research and earlier studies with uTRACE as well as protocol discussions with Key Opinion Leaders.

About the uPAR theranostic platform

Curasight’s uPAR theranostic platform combines two key technologies – uTRACE and uTREAT both targeting the uPAR receptor. uTRACE is designed to deliver sensitive imaging for diagnosis, while uTREAT offers a targeted radiopharmaceutical solution. Together, they form an integrated approach to improving the diagnosis and treatment of cancers that express uPAR. Curasight’s ambition is to develop both uTRACE and uTREAT to improve diagnosis and treatment of uPAR-expressing cancers.

About high grade glioma

Treatment of glioblastoma and other high-grade gliomas (WHO grades 3 or 4) presents a significant unmet medical need, necessitating innovative and effective treatments. A total of approx. 65,000 patients are diagnosed with primary brain tumors and more than 30,000 patients are diagnosed annually with the most aggressive form, glioblastoma, in the US and EU. Approximately 10 % of the patients are children. The prognosis for individuals with glioblastoma is very poor as approximately 50% of the patients die within 14 months and after five years from diagnosis only 5% are still alive. External beam radiation is a cornerstone in the therapy of brain cancers. uTREAT could potentially replace or reduce the use of external beam radiation and thereby lower side effects to the healthy brain due to more specific tumor tissue targeting.

(Press release, Curasight, DEC 18, 2025, View Source [SID1234661545])

New Data from SkylineDx Demonstrates Merlin CP-GEP Test’s Superior Melanoma Risk Stratification

On December 18, 2025 SkylineDx reported the release of new data from two complementary, peer-reviewed publications that reinforce the clinical value of the Merlin CP-GEP Test for melanoma risk stratification. Together, these studies demonstrate that prospectively validated genomic tools are essential to improve clinical decision-making and reduce both under- and overtreatment in early-stage melanoma.

The Merlin CP-GEP Test, validated in the largest prospective gene expression profiling study in melanoma (MERLIN_001), demonstrated that a High-Risk result identifies patients with a threefold increased risk of SLNB positivity compared to Low-Risk, and consistently above the 10% threshold referenced in major guidelines.

Despite 75% of melanoma being diagnosed at an early T1 stage1, the disease still accounts for a disproportionate share of skin cancer mortality with more than half of melanoma-related deaths coming from patients who initially presented with "early-stage" disease. These findings reinforce a growing consensus across oncology: accurate, prospectively validated risk-assessment tools must be incorporated into standard-of-care, just as they are in breast, prostate, and thyroid cancer.

Analysis Clarifies Misleading Benchmarks in Competitor’s Prior Comparison

In a peer-reviewed publication2, SkylineDx investigators conducted a rigorous analysis of a comparative assessment3 used to support DecisionDx-Melanoma. When patient cohorts were harmonized and improper exclusions were corrected, the Merlin CP-GEP Test demonstrated superior metastatic-risk stratification and more accurate prediction of SLNB outcomes across real-world disease prevalence ranges. The analysis revealed that earlier comparisons relied on methodologically flawed cohorts and selectively chosen performance benchmarks, leading to conclusions that were not scientifically valid. When evaluated under aligned and transparent conditions, the Merlin CP-GEP Test consistently delivered higher clinical utility.

New T1a Publication Shows Merlin CP-GEP Test Identifies High-Risk Patients That Were Missed by Traditional Adverse Features

A newly published analysis4 in Journal of American Academy of Dermatology about early-stage T1a melanoma showed that Merlin CP-GEP High-Risk reliably identifies patients with >10% risk of SLNB metastasis, suggesting these individuals should be prioritized for surgical oncology consultation. The study highlights that Merlin CP-GEP Test outperforms using traditional high-risk features for assessment, including age, lymphovascular invasion, and mitotic rate, supporting the Test’s use as an additional high-risk tool in guiding SLNB decision-making.

"Melanoma clinicians need tools that are not only innovative but proven through rigorous, prospective, and blinded clinical validation," said Alexander Meves, MD, Mayo Clinic. "The Merlin CP-GEP Test has demonstrated an improvement over traditional clinicopathologic features and showed in the MERLIN_001 trial that High-Risk patients carry a significantly elevated risk—above key guideline thresholds. Tools with this level of evidence should be integrated into clinical pathways to support more individualized and accurate decision-making for our patients."

(Press release, SkylineDx, DEC 18, 2025, View Source [SID1234661544])

Niowave Expands Global Supply Agreement with AstraZeneca to Deliver Actinium-225 for Next-Generation Cancer Therapies

On December 18, 2025 Niowave Inc., a U.S.- based global leader in medical radioisotope production, reported the expansion of its existing supply agreement with AstraZeneca, a global biopharmaceutical company, to a 10-year commitment to deliver Actinium-225 (Ac-225), following AstraZeneca’s decision to exercise its option to increase capacity. The agreement secures a reliable and scalable supply of this critical isotope to advance AstraZeneca’s growing portfolio of radioconjugates (RCs). RCs are a type of cancer treatment that use radioactive particles to target and destroy cancer cells.

"Our expanded agreement with AstraZeneca underscores Niowave’s central role in scaling high-quality production of medical radioisotopes for the development of targeted cancer treatments," said Mike Zamiara, CEO of Niowave. "We are pleased to play a role in ensuring that AstraZeneca’s promising pipeline of radioconjugates have the isotope supply they need."

Ac-225 is one of the most promising radioisotopes in oncology as its emitted alpha particles deliver highly potent, DNA-damaging energy, enabling precise destruction of tumor cells while limiting harm to surrounding healthy tissue with targeted modalities like RCs. Despite its potential, global supply of Ac-225 remains limited. Niowave’s proprietary superconducting linear accelerator technology and radiochemistry provide sustainable, U.S.-based production to address this need.

As AstraZeneca advances RCs for prostate and other difficult-to-treat cancers, the agreement highlights the critical importance of securing dependable isotope supply.

(Press release, AstraZeneca, DEC 18, 2025, View Source [SID1234661543])