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 from other lung cancer “biomarkers” by focusing strictly upon characterization of a radiologically indeterminate lung mass. The CB TestTM is on track to become a rapid, low-‐ cost test that complements information readily available by CT to accelerate and inform the early diagnosis of lung cancer.
“We believe that the CB Test has the potential to help evaluate the risk associated with indeterminate lung masses,” said Steven Eror, chief executive officer of Freshmedx. “Better risk assessment translates into accelerated access to tissue diagnosis and treatment. In those cases when lung cancer is detected early and resected, the 5-‐year survival rate for patients improves from 16% to 70%, according to the National Cancer Institute. CT follow-‐up is a very important objective for us. We are very passionate about the cost effective CB Test and excited for it to become available on a global basis.”
The primary investigator is expected to present the details of the Freshmedx sponsored clinical trial design and its results 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. In addition to the four completed clinical trials in the United States, Freshmedx has one trial nearing completion in Mexico and two more planned to start in Asia this year.
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.
ABOUT LUNG CANCER
Lung cancer is the deadliest form of cancer, killing 160,000 people in the United States and over 1.3 million people world wide every year. Over half of lung cancer patients are not smokers or former smokers. The five-‐year survival rate of an individual diagnosed with lung cancer is only 16%. This low survival rate has been attributed to the incurable locally advanced and metastatic disease typically present in 84% of the patients diagnosed with lung cancer.
Freshmedx is a private, Utah-‐based company focused on development, manufacturing, marketing and sales of non-‐invasive medical diagnostics for life-‐ threatening disease. Freshmedx’s initial target is to improve the accuracy of pre-‐surgical diagnosis of lung cancer, with other applications of its device platform in development. The testing and devices described in this release are investigational and the related statements have not been approved for marketing by the US FDA.
Media Contact, Public Relations, Catherine Garff
Freshmedx 801-‐599-‐5224, CEG@freshmedx.com
757 East South Temple, Suite 150 Salt Lake City, Utah 84102 U.S.A.