bioAffinity said at present, recruitment is ongoing for patients diagnosed with lung cancer and individuals at high risk for the disease who have undergone screening.

The validation trial follows earlier clinical studies that resulted in the final design of the non-invasive test that will support physicians in determining whether or not biopsy or other invasive diagnostic testing are warranted after screening a patient for lung cancer with low-dose computer tomography (LDCT).

bioAffinity Technologies president and CEO Maria Zannes said: “Lung cancer is the leading cancer killer worldwide, claiming nearly 1.6 million lives annually. If detected and treated early at Stage 1, the dismal five-year survival rate of 18% leaps to a 10-year survival rate of 88%.”

For the CyPath test, the participants need to provide sputum samples over a three-day period with the help of an airway assist device that helps open and clear the lungs.

Four clinical sites, at Summit Medical Group in New Jersey, Radiology Association of Albuquerque in New Mexico, Waterbury Pulmonary Associates in Connecticut and Atlantic Health Systems in New Jersey have been selected to enroll volunteers for the study.

Four additional collection sites are presently undergoing review and seeking approval from Institutional Review Boards (IRBs).

At present, screening with LDCT is recommended for people above the age of 55, who have smoked an equivalent of 30 years or more and have not quit within the last 15 years.

Zannes continued saying: “Screening can save lives, but LDCT currently has a 96% false-positive rate, and there is currently no consistently reliable, non-invasive method that can detect lung cancer at an early stage.”

Zannes stated that the CyPath Lung is expected to be commercially available by this year end for physicians who need to determine whether surgical biopsy or monitoring is the best option for their patients.

The product is claimed to have been designed to be very accurate and affordable non-invasive, early-stage lung cancer diagnostic in the market.