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 20%. Screening is now approved in the United States for those patients who meet age and smoking history requirements. While the uptake of these programs has been slow, 2024 saw a record number of LDCT screens for high-risk patients, and clinicians expect this trend to continue as public education improves.

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 19.4% to 3.7%, representing a five-fold reduction in false positives. More recently, an evaluation of MSC in the BioMILD trial, published in The Lancet Regional Health – Europe, confirmed earlier findings demonstrating the accuracy and efficacy of the test in combination with LDCT.

“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.

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Media and Investor Contact:
Wendy Blosser
Email: investors@accustem.com