March 22, 2011— Freshmedx today announced the completion of a clinical trial at a major medical center in Baltimore. Freshmedx’s proprietary Computerized Bioconductance Test (CB TestTM) showed favorable results in distinguishing between benign and malignant indeterminate masses by chest CT in undiagnosed individuals with lung cancer symptoms. In this trial, the CB TestTM demonstrated 90% sensitivity and 92% specificity in distinguishing between benign and malignant masses confirmed by biopsy or stable disease.
Many heavy smokers and others at risk of lung cancer have lung nodules that show up on CT scans as indeterminate (unidentifiable) lung masses. Few of these are malignant, but in order to save lives, physicians must resolve diagnosis of these indeterminate masses early in order to allow for swift biopsy and therapeutic intervention. The current practice requires patients to wait months or even years for their mass to grow in order to confirm (via CT scan) the likelihood of malignancy or face an invasive or open lung biopsy.
“This technology has the potential to reduce the stressful waiting period for those who have indeterminate masses and often undergo additional CT evaluation prior to receiving biopsy,” said Karleen Callahan, Ph.D., vice president of clinical affairs for Freshmedx. “There are millions of people at high risk of lung cancer, many who are living with smaller indeterminate masses who must wait months for additional CT scanning to determine whether the mass is growing and requires biopsy. The CB Test has the potential to be administered immediately upon discovery of an indeterminate finding by CT, and helps inform the physician whether an immediate biopsy is warranted or if longer term, radiological follow-‐up is appropriate.”
The CB TestTM is non-‐invasive, simple to perform, involves no ionizing radiation and differs […]