NEW YORK (360Dx) – BioAffinity Technologies today said that it has inked a licensing agreement with Precision Pathology Services for the continued development and commercial sale of its CyPath Lung assay as a laboratory-developed test used for the diagnosis of early-stage lung cancer.
BioAffinity President and CEO Maria Zannes said that Precision Pathology will develop the test as an LDT for commercial sale by the first-quarter of 2019.
Precision Pathology will market the test nationwide to major hospitals and large pulmonary and internal medicine practices, and to rural and smaller medical centers and practices. It will also market CyPath Lung to clinicians and their patients to assist with diagnosis after a positive result from low dose computed tomography screening (LDCT).
Financial and other terms of the deal were not disclosed.
The test detects porphyrin molecules in sputum samples. Its technology preferentially binds to cancer cells collected in the samples and causes them to fluoresce in contrast to non-cancer cells. It uses flow cytometry to evaluate the sample for the presence of cancer and cancer-related cells that can indicate the presence of a malignant tumor.
LDCT has a high false-positive rate of 96.4 percent that can lead to invasive and expensive follow-up, including PET scans, bronchoscopy, and lung biopsy to confirm a lung cancer diagnosis, BioAffinity said. The CyPath Lung test can lower the number of unnecessary invasive procedures and improve the positive predictive value of lung cancer screening and diagnosis, it added.
BioAffinity noted that insurance reimbursement codes are available for use with CyPath Lung at a national CPT allowance of $380. The firm said that based on its own analysis, the test could save nearly $1 billion in healthcare costs for each 1 million people who undergo LDCT screening for lung cancer, assuming those with a positive result use CyPath Lung to confirm diagnosis.