US-based diagnostics company AccuStem Sciences has unveiled its plans to launch its microRNA Signature Classifier (MSC) blood test for lung cancer screening in the US.
The MSC blood test was developed by researchers at Istituto Nazionale Tumori in Italy.
The test, which analyses microRNAs from blood samples, is intended for screening lung cancer in more than 1.6 million US patients diagnosed with nodules.
AccuStem aims to expand the test’s use to all 15 million at-risk individuals, who are eligible for lung cancer screening each year in the US.
The company is currently using the MSC blood test in the RISP clinical trial with plans to commercialise the test in the US by 2026.
AccuStem CEO Wendy Blosser said: “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.”
According to AccuStem, the test has been validated in over 5,000 patients in clinical trials.
The National Lung Screening Trial showed that low-dose computed tomography (LDCT) scanning is recommended for early detection of lung cancer.
The study revealed a 20% reduction in lung cancer mortality among smokers using LDCT.
A study published in the Journal of Clinical Oncology showed that the MSC blood test reduced LDCT’s false positive rate from 19.4% to 3.7%.
The BioMILD trial, published in The Lancet Regional Health – Europe, further validated the test, confirming its accuracy when combined with LDCT.
BioMILD trial thoracic surgeon and PI Ugo Pastorino said: “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.
“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.”
