AccuStem Sciences to Offer its MSC Blood Test to Lung Cancer Screening Programs in the United States
AccuStem Sciences (OTCQB: ACUT) announces plans to launch its microRNA Signature Classifier (MSC) blood test for lung cancer screening in the US. The test will initially target 1.6 million patients diagnosed yearly with nodules, with potential expansion to 15 million at-risk patients qualifying for annual screening.
The MSC test, developed at Istituto Nazionale Tumori, has been evaluated in over 5,000 patients across multiple clinical trials. When combined with low dose computed tomography (LDCT), MSC reduced false positive rates from 19.4% to 3.7%. The BioMILD trial showed MSC+ patients are four times more likely to have or develop lung cancer compared to MSC- patients.
AccuStem aims to commercialize the test in the US in 2026, potentially reducing unnecessary lung biopsies and healthcare costs. The company sees this as a significant opportunity to improve care outcomes for patients with lung nodules and plans to expand its use as a pre-screening tool before LDCT.
AccuStem Sciences (OTCQB: ACUT) annuncia piani per lanciare il suo test del sangue microRNA Signature Classifier (MSC) per lo screening del cancro ai polmoni negli Stati Uniti. Il test mirerà inizialmente a 1,6 milioni di pazienti diagnosticati annualmente con noduli, con una potenziale espansione a 15 milioni di pazienti a rischio idonei per lo screening annuale.
Il test MSC, sviluppato presso l'Istituto Nazionale Tumori, è stato valutato in oltre 5.000 pazienti in diversi studi clinici. Quando combinato con la tomografia computerizzata a bassa dose (LDCT), il MSC ha ridotto i tassi di falsi positivi dal 19,4% al 3,7%. Lo studio BioMILD ha dimostrato che i pazienti MSC+ hanno quattro volte più probabilità di avere o sviluppare un cancro ai polmoni rispetto ai pazienti MSC-.
AccuStem mira a commercializzare il test negli Stati Uniti nel 2026, riducendo potenzialmente le biopsie polmonari non necessarie e i costi sanitari. L'azienda vede questa come un'opportunità significativa per migliorare i risultati di cura per i pazienti con noduli polmonari e prevede di espandere il suo utilizzo come strumento di pre-screening prima della LDCT.
AccuStem Sciences (OTCQB: ACUT) anuncia planes para lanzar su prueba de sangre microRNA Signature Classifier (MSC) para la detección de cáncer de pulmón en los EE. UU. La prueba inicialmente se dirigirá a 1.6 millones de pacientes diagnosticados anualmente con nódulos, con una posible expansión a 15 millones de pacientes en riesgo que califiquen para el screening anual.
La prueba MSC, desarrollada en el Instituto Nacional de Tumores, ha sido evaluada en más de 5,000 pacientes a través de múltiples ensayos clínicos. Cuando se combina con tomografía computarizada de baja dosis (LDCT), el MSC redujo las tasas de falsos positivos del 19.4% al 3.7%. El ensayo BioMILD mostró que los pacientes MSC+ tienen cuatro veces más probabilidades de tener o desarrollar cáncer de pulmón en comparación con los pacientes MSC-.
AccuStem tiene como objetivo comercializar la prueba en EE. UU. en 2026, lo que podría reducir las biopsias pulmonares innecesarias y los costos de atención médica. La empresa ve esto como una oportunidad significativa para mejorar los resultados de atención para los pacientes con nódulos pulmonares y planea expandir su uso como herramienta de pre-screening antes de la LDCT.
AccuStem Sciences (OTCQB: ACUT)는 미국에서 폐암 검진을 위한 microRNA Signature Classifier (MSC) 혈액 검사를 출시할 계획을 발표했습니다. 이 검사는 매년 결절로 진단받는 160만 명의 환자를 처음으로 목표로 하며, 연간 검진에 적합한 1500만 명의 고위험 환자로 확대될 가능성이 있습니다.
이 MSC 검사는 이탈리아 국립 종양 연구소에서 개발되었으며, 여러 임상 시험에서 5,000명 이상의 환자를 대상으로 평가되었습니다. 저선량 컴퓨터 단층촬영(LDCT)과 결합했을 때, MSC는 위양성률을 19.4%에서 3.7%로 줄였습니다. BioMILD 시험에서는 MSC+ 환자가 MSC- 환자에 비해 폐암에 걸리거나 발전할 가능성이 네 배 더 높다는 결과가 나타났습니다.
AccuStem은 2026년까지 미국에서 이 검사를 상용화할 계획이며, 이는 불필요한 폐 생검과 의료 비용을 줄일 수 있습니다. 이 회사는 이를 폐 결절 환자의 치료 결과를 개선할 수 있는 중요한 기회로 보고 있으며, LDCT 이전에 사전 검진 도구로서의 사용을 확대할 계획입니다.
AccuStem Sciences (OTCQB: ACUT) annonce des projets pour lancer son test sanguin microRNA Signature Classifier (MSC) pour le dépistage du cancer du poumon aux États-Unis. Le test ciblera initialement 1,6 million de patients diagnostiqués chaque année avec des nodules, avec une expansion potentielle à 15 millions de patients à risque éligibles pour un dépistage annuel.
Le test MSC, développé à l'Institut National du Cancer, a été évalué chez plus de 5 000 patients lors de plusieurs essais cliniques. Lorsqu'il est associé à la tomodensitométrie à faible dose (LDCT), le MSC a réduit le taux de faux positifs de 19,4 % à 3,7 %. L'essai BioMILD a montré que les patients MSC+ ont quatre fois plus de chances d'avoir ou de développer un cancer du poumon par rapport aux patients MSC-.
AccuStem vise à commercialiser le test aux États-Unis en 2026, ce qui pourrait réduire les biopsies pulmonaires inutiles et les coûts de santé. L'entreprise considère cela comme une opportunité significative d'améliorer les résultats de soins pour les patients ayant des nodules pulmonaires et prévoit d'élargir son utilisation en tant qu'outil de pré-dépistage avant la LDCT.
AccuStem Sciences (OTCQB: ACUT) kündigt Pläne zur Einführung seines microRNA Signature Classifier (MSC) Bluttests zur Lungenkrebsfrüherkennung in den USA an. Der Test richtet sich zunächst an 1,6 Millionen Patienten, die jährlich mit Knoten diagnostiziert werden, mit einer potenziellen Erweiterung auf 15 Millionen gefährdete Patienten, die für das jährliche Screening qualifiziert sind.
Der MSC-Test, der am Nationalen Tumorinstitut entwickelt wurde, wurde in über 5.000 Patienten in mehreren klinischen Studien bewertet. In Kombination mit der Niedrigdosis-Computertomographie (LDCT) reduzierte der MSC die falsch-positiven Raten von 19,4 % auf 3,7 %. Die BioMILD-Studie zeigte, dass MSC+-Patienten viermal häufiger an Lungenkrebs erkranken oder diesen entwickeln als MSC--Patienten.
AccuStem plant, den Test 2026 in den USA zu kommerzialisieren, was potenziell unnötige Lungenbiopsien und Gesundheitskosten senken könnte. Das Unternehmen sieht dies als eine bedeutende Gelegenheit, die Behandlungsergebnisse für Patienten mit Lungenknoten zu verbessern, und plant, die Verwendung als Vorscreening-Tool vor der LDCT auszubauen.
- Large addressable market of 1.6 million patients annually, expandable to 15 million at-risk patients
- Strong clinical validation with over 5,000 patients across multiple trials
- Significant improvement in screening accuracy: 5-fold reduction in false positives when combined with LDCT
- Potential cost savings through reduction in unnecessary biopsies
- Commercialization not expected until 2026
- Will face competition from established LDCT screening protocols
- Currently trading on OTCQB market, indicating lower tier exchange listing
LONDON and PHOENIX, April 04, 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, announces plans to launch its microRNA Signature Classifier (MSC) blood test for use in the more than 1.6 million US patients diagnosed each year with nodules as part of current lung cancer screening protocols. The company believes it will be able to further expand the use of the test to all of the 15 million at-risk patients who qualify for lung cancer screening annually in the US.
Lung cancer is currently the most commonly diagnosed cancer worldwide with nearly 2.5 million new cases each year and is responsible for 1 in 5 cancer deaths as it is typically detected at a late stage. To improve outcomes for these patients, low dose computed tomography (LDCT) scanning is now recommended for earlier detection of the disease based upon the results of the National Lung Screening Trial. This pivotal study demonstrated that the use of LDCT in patients with a history of smoking reduced lung cancer mortality by
While LDCT represents an effective non-invasive solution for detecting lung cancer, clinicians still see many false positive results with imaging alone. To improve upon the limitations of LDCT, researchers at the Istituto Nazionale Tumori (INT) developed a novel diagnostic test, MSC, to identify those patients more accurately with or at risk of lung cancer. The test, which interrogates several micro RNAs (miRNAs) using a blood sample, has been evaluated in over 5,000 patients across several prospective clinical trials and published in top-tier scientific journals. One such study from the Journal of Clinical Oncology showed that combining LDCT and MSC lowered the false positive rate of LDCT alone from
“We are extremely pleased with the results from our additional clinical work in the BioMILD cohort, showing that MSC+ patients are more than four times as likely to have or develop lung cancer compared to MSC- patients,” said Ugo Pastorino, MD, thoracic surgeon and PI of the BioMILD trial. “We believe these most recent data published in Lancet show the value of integrating MSC as a standard of care in the lung cancer screening workup process.”
Research from the inventors of the test, Gabriella Sozzi, MD, Mattia Boeri, PhD and Ugo Pastorino, MD, demonstrates that MSC can accurately stratify patients with lung nodules and could ultimately save costs to the healthcare system by reducing the number of unnecessary lung biopsies. The test is currently in use as part of the RISP clinical trial and AccuStem is now focused on commercializing the test in the US in 2026.
“We see a large opportunity for MSC to meaningfully impact the care and outcomes for the 1.6 million patients diagnosed each year with lung nodules in the US,” said Wendy Blosser, CEO of AccuStem. “Additionally, we plan to expand the use of the test to all patients at risk of lung cancer. This would place MSC in front of LDCT screening and could identify those patients most likely to benefit from imaging, impacting as many as 15 million US patients annually.”
About AccuStem
AccuStem is a clinical stage diagnostics company dedicated to optimizing outcomes and quality of life for all patients with or at risk of 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.
Forward-Looking Statements
This press release contains “forward-looking statements” Forward-looking statements reflect our current view about future events. When used in this press release, the words “anticipate,” “believe,” “estimate,” “expect,” “future,” “intend,” “plan,” or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements, include, but are not limited to, statements contained in this press release relating to our business strategy, our future operating results and liquidity and capital resources outlook. Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward–looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other factors relating to our industry, our operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned.
Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We cannot guarantee future results, levels of activity, performance, or achievements. AccuStem Sciences, Inc. assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release.
Media and Investor Contact:
Wendy Blosser
Email: investors@accustem.com
FAQ
What are the clinical trial results for AccuStem's (ACUT) MSC blood test in lung cancer screening?
When will AccuStem (ACUT) launch its MSC blood test in the United States?
How many patients could potentially benefit from AccuStem's (ACUT) MSC test?
What is the market opportunity for AccuStem's (ACUT) MSC blood test?
