Freshmedx, a private, Utah-based company focused on development, manufacturing, marketing and sales of non-invasive medical diagnostics for life-threatening disease, has completed its proprietary Computerized Bioconductance Test (CB Test) clinical trial.
Freshmedx said the CB Test is non-invasive, simple to perform, involves no ionizing radiation and differs from other lung cancer ‘biomarkers’ by focusing strictly upon characterization of a radiologically indeterminate lung mass.
In the trial, the CB Test demonstrated 90% sensitivity and 92% specificity in distinguishing between benign and malignant indeterminate masses confirmed by biopsy or stable disease.
The details of the Freshmedx sponsored clinical trial design and its results are expected to be presented at several conferences later this year, including the International Association for the Study of Lung Cancer World Conference on Lung Cancer and the European Respiratory Society Annual Congress.
Freshmedx also has partnering and distribution relationships in Mexico and China where the pre-biopsy evaluation of lung cancer may be limited to those with the resources and access to advanced technologies.
Freshmedx Clinical Affairs VP Karleen Callahan said 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.