AccuStem Sciences, Inc. Signs Agreement to Access Blood Samples from Lung Cancer Screening Trial to Expedite MSC Commercialization Plan
AccuStem Sciences (OTCQB: ACUT) has signed a development agreement to access blood samples from the Rete Italiana di Screening Polmonare (RISP) clinical trial for its microRNA Signature Classifier (MSC) test development. The trial spans 18 centers in Italy.
The MSC test analyzes 24 miRNAs in plasma samples from patients with lung nodules to enhance low dose computed tomography (LDCT) screening accuracy. The MILD trial showed that combining MSC with LDCT could reduce false positive rates by a factor of five. The test has been validated across 5,000+ patients in multiple prospective trials.
The agreement includes statistical and analytical support to help AccuStem establish and commercialize the MSC test in the US, with a planned launch in 2026. The technology aims to improve patient triage, enhance outcomes, and reduce healthcare costs when used in conjunction with LDCT screening.
AccuStem Sciences (OTCQB: ACUT) ha firmato un accordo di sviluppo per accedere ai campioni di sangue del trial clinico Rete Italiana di Screening Polmonare (RISP) per lo sviluppo del suo test microRNA Signature Classifier (MSC). Lo studio coinvolge 18 centri in Italia.
Il test MSC analizza 24 miRNA in campioni di plasma di pazienti con noduli polmonari per migliorare l'accuratezza dello screening con tomografia computerizzata a basso dosaggio (LDCT). Il trial MILD ha dimostrato che combinare MSC con LDCT può ridurre i falsi positivi di cinque volte. Il test è stato convalidato su oltre 5.000 pazienti in diversi studi prospettici.
L'accordo prevede supporto statistico e analitico per aiutare AccuStem a sviluppare e commercializzare il test MSC negli Stati Uniti, con un lancio previsto nel 2026. La tecnologia punta a migliorare il triage dei pazienti, ottimizzare i risultati e ridurre i costi sanitari se utilizzata insieme allo screening LDCT.
AccuStem Sciences (OTCQB: ACUT) ha firmado un acuerdo de desarrollo para acceder a muestras de sangre del ensayo clínico Rete Italiana di Screening Polmonare (RISP) para el desarrollo de su prueba microRNA Signature Classifier (MSC). El estudio abarca 18 centros en Italia.
La prueba MSC analiza 24 miARN en muestras de plasma de pacientes con nódulos pulmonares para mejorar la precisión del cribado con tomografía computarizada de baja dosis (LDCT). El ensayo MILD demostró que combinar MSC con LDCT podría reducir las tasas de falsos positivos en un factor de cinco. La prueba ha sido validada en más de 5,000 pacientes en múltiples estudios prospectivos.
El acuerdo incluye apoyo estadístico y analítico para ayudar a AccuStem a establecer y comercializar la prueba MSC en EE.UU., con un lanzamiento previsto para 2026. La tecnología busca mejorar la clasificación de pacientes, optimizar resultados y reducir costos sanitarios cuando se usa junto con el cribado LDCT.
AccuStem Sciences (OTCQB: ACUT)는 마이크로RNA 시그니처 분류기(MSC) 테스트 개발을 위해 이탈리아 폐 스크리닝 네트워크(RISP) 임상시험의 혈액 샘플에 접근하는 개발 계약을 체결했습니다. 이 임상시험은 이탈리아 내 18개 센터에서 진행됩니다.
MSC 테스트는 폐 결절 환자의 혈장 샘플에서 24개의 miRNA를 분석하여 저선량 컴퓨터단층촬영(LDCT) 스크리닝의 정확도를 향상시킵니다. MILD 임상시험 결과 MSC와 LDCT를 결합하면 위양성률을 5배 줄일 수 있음이 입증되었습니다. 이 테스트는 5,000명 이상의 환자를 대상으로 한 다수의 전향적 연구에서 검증되었습니다.
이번 계약에는 AccuStem이 미국에서 MSC 테스트를 개발 및 상용화할 수 있도록 통계 및 분석 지원이 포함되어 있으며, 2026년 출시가 계획되어 있습니다. 이 기술은 LDCT 스크리닝과 함께 사용 시 환자 분류 개선, 결과 향상 및 의료 비용 절감을 목표로 합니다.
AccuStem Sciences (OTCQB : ACUT) a signé un accord de développement pour accéder aux échantillons sanguins de l’essai clinique Rete Italiana di Screening Polmonare (RISP) afin de développer son test microRNA Signature Classifier (MSC). L’essai regroupe 18 centres en Italie.
Le test MSC analyse 24 miARN dans des échantillons de plasma de patients présentant des nodules pulmonaires pour améliorer la précision du dépistage par tomodensitométrie à faible dose (LDCT). L’essai MILD a montré que la combinaison du MSC avec la LDCT pouvait réduire par cinq le taux de faux positifs. Le test a été validé auprès de plus de 5 000 patients dans plusieurs essais prospectifs.
L’accord inclut un soutien statistique et analytique pour aider AccuStem à développer et commercialiser le test MSC aux États-Unis, avec un lancement prévu en 2026. Cette technologie vise à améliorer le triage des patients, optimiser les résultats et réduire les coûts de santé lorsqu’elle est utilisée en complément du dépistage LDCT.
AccuStem Sciences (OTCQB: ACUT) hat eine Entwicklungsvereinbarung unterzeichnet, um Zugang zu Blutproben der klinischen Studie Rete Italiana di Screening Polmonare (RISP) für die Entwicklung ihres microRNA Signature Classifier (MSC)-Tests zu erhalten. Die Studie umfasst 18 Zentren in Italien.
Der MSC-Test analysiert 24 miRNAs in Plasmaproben von Patienten mit Lungenknoten, um die Genauigkeit des Low-Dose-Computertomographie (LDCT)-Screenings zu verbessern. Die MILD-Studie zeigte, dass die Kombination von MSC mit LDCT die Rate falsch-positiver Ergebnisse um den Faktor fünf reduzieren kann. Der Test wurde in über 5.000 Patienten in mehreren prospektiven Studien validiert.
Die Vereinbarung beinhaltet statistische und analytische Unterstützung, um AccuStem bei der Etablierung und Kommerzialisierung des MSC-Tests in den USA zu helfen, mit einem geplanten Start im Jahr 2026. Die Technologie zielt darauf ab, die Patientenselektion zu verbessern, die Ergebnisse zu optimieren und die Gesundheitskosten bei gleichzeitiger Anwendung mit LDCT-Screening zu senken.
- MSC test reduces LDCT false positive rates by 80%
- Extensive validation with over 5,000 patients in multiple trials
- Access to samples and expertise from 18 Italian medical centers
- Clear commercialization timeline with US launch planned for 2026
- Product not yet commercialized in any market
- Dependent on successful regulatory approval for 2026 US launch
LONDON and PHOENIX, April 16, 2025 (GLOBE NEWSWIRE) -- AccuStem Sciences, Inc. (OTCQB: ACUT), a clinical stage diagnostics company dedicated to improving outcomes for patients with or at risk of cancer, today announced a development agreement to access blood samples from the multi-institutional, prospective, randomized Rete Italiana di Screening Polmonare (RISP) clinical trial. This study is currently enrolling patients across a clinical network of 18 centers in Italy, and will further demonstrate the impact of AccuStem’s microRNA Signature Classifier (MSC) test in the lung cancer screening setting. The agreement will also provide statistical and analytical support and subject matter expertise to AccuStem to establish and commercialize the MSC test in the US.
“Access to our collaborators’ expertise and support will help us further expand on the utility of the MSC test and ensure that we are able to expedite integration of this novel technology as a standard of care that improves the accuracy of lung cancer screening,” said Wendy Blosser, Chief Executive Officer of AccuStem.
Recently, research has shown the potential of micro RNAs (miRNAs) for the early detection of imperceptible cancers with a simple blood draw. The MSC test evaluates 24 miRNAs in plasma samples from patients diagnosed with lung nodules to improve the performance of low dose computed tomography (LDCT) screening alone. Importantly, the MILD trial demonstrated that MSC in combination with LDCT has the potential to reduce the false positive rate of LDCT alone by a factor of five. The test has been extensively validated in more than 5,000 patients from multiple prospective trials that have demonstrated MSC’s ability to more accurately stratify patients according to their probability of developing cancer. Together, MSC and LDCT have the potential to better triage patients diagnosed with lung nodules, improve patient outcomes and save costs to the healthcare system.
“As the inventors of the MSC test, we have been focused on increasing the value and impact of lung cancer screening programs globally,” said Mattia Boeri, Group Leader at the Experimental Oncology Department of INT. “LDCT screening has had a measurable impact on outcomes for patients with lung nodules, and our technology will help improve its performance while simultaneously reducing costs related to screening. We see this as a win for patients, providers and the broader healthcare system.”
AccuStem is pursuing a strategic commercialization plan intending to launch the MSC test in the US in 2026.
About AccuStem
AccuStem is a clinical stage diagnostics company dedicated to optimizing outcomes and quality of life for all patients with cancer. We plan to drive innovation in healthcare by offering proprietary molecular testing that addresses unmet clinical needs from cancer screening through treatment and monitoring. By interrogating novel disease pathways, such as tumor “stemness”, we believe our tools will help care teams better understand the biology of each patient’s cancer, leading to more informed decision making.
For more information, please visit www.accustem.com.
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Media Contact:
Jeff Fensterer
Email: jeff@accustem.com
Investor Contact:
Wendy Blosser
Email: investors@accustem.com
FAQ
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