AccuStem Sciences, Inc. (OTCQB: ACUT) has announced plans to launch its innovative microRNA Signature Classifier (MSC) blood test for lung cancer screening in the United States. The clinical-stage diagnostics company aims to initially target the more than 1.6 million US patients diagnosed annually with lung nodules through current screening protocols, with potential expansion to all 15 million at-risk patients who qualify for annual lung cancer screening.
Lung cancer remains the most commonly diagnosed cancer globally, with approximately 2.5 million new cases each year. It accounts for one in five cancer deaths, largely due to late-stage detection. Low-dose computed tomography (LDCT) scanning has been recommended for earlier detection based on the National Lung Screening Trial, which demonstrated a 20% reduction in lung cancer mortality among patients with smoking history.
Addressing LDCT Limitations with MSC Technology
Despite LDCT's effectiveness as a non-invasive detection method, clinicians frequently encounter false positive results with imaging alone. The MSC blood test, developed by researchers at Italy's Istituto Nazionale Tumori (INT), was designed to overcome these limitations by more accurately identifying patients with or at risk of lung cancer.
The test analyzes several micro RNAs (miRNAs) from a simple blood sample and has been evaluated in over 5,000 patients across multiple prospective clinical trials. Results published in the Journal of Clinical Oncology demonstrated that combining LDCT and MSC reduced the false positive rate from 19.4% to just 3.7% – a five-fold improvement.
"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 Dr. Ugo Pastorino, thoracic surgeon and Principal Investigator 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."
Clinical Validation and Future Implementation
The BioMILD trial results, published in The Lancet Regional Health – Europe, confirmed earlier findings on the accuracy and efficacy of the MSC test when used in combination with LDCT. Research from the test inventors – Dr. Gabriella Sozzi, Dr. Mattia Boeri, and Dr. Ugo Pastorino – demonstrates that MSC can accurately stratify patients with lung nodules and potentially reduce healthcare costs by decreasing unnecessary lung biopsies.
The MSC test is currently being utilized in the RISP clinical trial, with AccuStem focusing on commercializing the test in the US by 2026.
Expanding Access to Improve Patient Outcomes
Wendy Blosser, CEO of AccuStem, highlighted the significant potential impact of the technology: "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. 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."
Potential Healthcare System Benefits
The integration of MSC into standard lung cancer screening protocols could yield substantial benefits for the healthcare system. By reducing false positives and unnecessary follow-up procedures, the test may decrease both patient anxiety and healthcare costs. The ability to more accurately stratify patients based on their actual risk could allow for more personalized screening approaches.
The uptake of lung cancer screening programs has historically been slow, but 2024 saw record numbers of LDCT screens for high-risk patients. Clinicians expect this trend to continue as public education improves, potentially creating a growing market for complementary diagnostic tools like MSC.
Novel Approach to Cancer Diagnostics
AccuStem's approach focuses on interrogating novel disease pathways, such as tumor "stemness," to help care teams better understand each patient's cancer biology. This approach aligns with the growing trend toward precision medicine in oncology, where treatment decisions are increasingly guided by molecular and genetic information rather than solely by traditional clinical factors.
As the company works toward commercialization in 2026, the MSC test represents a promising advance in the early detection and accurate diagnosis of lung cancer, potentially addressing a critical gap in current screening protocols.
