Clinical Study for Non-Invasive Lung Cancer Test Reports Promising Results
SEPTEMBER 23, 2015
(SAN ANTONIO, TX ) bioAffinity Technologies, a privately held cancer diagnostics company, today announced that results from a 128-patient proof-of-concept clinical study for its non-invasive and quantitative assay for early-stage lung cancer were published in the September 2015 issue of the Journal of Thoracic Oncology.
Study results show the patented CyPath® test was able to correctly classify cancer and high-risk cohorts with considerable accuracy. The article, “Early Detection of Lung Cancer with Meso Tetra (4-Carboxyphenyl) Porphyrin-Labeled Sputum,” concludes that the CyPath® assay has the potential to complement low-dose spiral computed tomography (LDCT) screening or serve as a stand-alone tool for the detection of early-stage lung cancer.
bioAffinity Technologies’ proprietary technology is based on a porphyrin compound that binds to cancer cells and causes them to fluoresce red under specific frequencies of light. The objective of the study was to determine whether CyPath® could differentiate between two highly comparable cohorts: patients with confirmed lung cancer and people at high risk of developing lung cancer. The high-risk cohort met requirements similar to those considered by the Center for Medicare and Medicaid Services (CMMS) for reimbursement.
Each participant provided a deep-lung sputum sample that was labeled with CyPath® and viewed under a fluorescent microscope for the presence of red fluorescent cells, which represent positive findings.
Quantitative measurements of the fluorescence on the CyPath®-labeled sample slides and other patient metrics were statistically analyzed to determine the predictive accuracy of the CyPath® technology. The porphyrin-based assay had an overall accuracy of 81% in the test population with a false-positive rate of 40% and negative predictive value of 83%. By comparison, LDCT, the standard procedure for early lung cancer detection, has a false-positive rate greater than 96%, according to studies published in the New England Journal of Medicine.
Principal Investigator Thomas Bauer II, M.D., Medical Director of Thoracic Oncology at Meridian Health, said, “The results of this study indicate that we can take advantage of the preferential binding of the porphyrins to cancer cells and its distinct fluorescent signature to develop an accurate, non-invasive method to diagnose lung cancer at the earliest stages when it is most treatable.”
bioAffinity Technologies currently is optimizing the assay in collaboration with researchers at The University of Texas Health Science Center at San Antonio.
bioAffinity Chief Executive Officer Maria Zannes said optimization research has lead to greater accuracy and refinement of the protocol. “We are developing methods to read the entire sputum sample for the presence of cancer in 10 to 15 minutes while increasing all measures of accuracy. The collaborative research will result in a commercial product that is easy for a patient to use and helpful to his or her physician by providing clear indications of the presence of cancer.”
About bioAffinity Technologies
bioAffinity Technologies, Inc. (www.bioaffinitytech.com) is a privately held development-stage company advancing proprietary screening and early‐stage diagnostic technology applicable to a broad range of cancers. The Company holds extensive U.S. and international patents that allow for global commercialization of its technology.