The study aims to establish and validate performance characteristics of the test, including accuracy, precision, reproducibility and analytical sensitivity, to support its commercialisation.
The test enables patients to non-invasively collect sputum samples at home and ship them to the laboratory for processing.
Precision Pathology developed it as a laboratory-developed test (LDT), using bioAffinity’s intellectual property.
The LDT certification of the test will enable physicians to order it for their patients who are suspected or at high risk for lung cancer.
Precision Pathology president Roby Joyce said: “With our development phase complete, we are very pleased to start the validation studies for certification of the CyPath Lung flow cytometry test as an LDT.
“This is a very exciting time for us. Lung cancer is the leading cancer killer. Our test for early detection of this dreaded disease can help many people live longer and healthier lives.”
A recently held validation trail for CyPath Lung by bioAffinity reported an 88% specificity and 82% sensitivity, which is similar to far more invasive procedures commonly used to diagnose lung cancer.
bioAffinity president Maria Zannes said: “Precision Pathology rightfully enjoys an excellent reputation for quick turnaround times while providing accurate pathology diagnoses. The company is known for its exceptionally responsive and helpful service to the physicians and patients it serves.
“Dr Joyce and his team will bring the same very high quality to CAP /CLIA validation of CyPath Lung and its eventual sale later this year. CyPath Lung is in excellent hands.”