Oral cancer kills more than 8,650 people each year in the United States, largely due to late diagnosis. PeriRx aims to fight those numbers with its SaliMark OSCC salivary test, which catches cancer in its earliest stages. Now the company has set its experience in salivary diagnoses on a larger target with much more at stake—lung cancer and the more than 150,ooo people it kills each year.
“Our salivary diagnostics is based on much more than 10 years of National Institutes of Health funded basic and clinical research,” said Jack L. Martin, BA, MD, chief medical officer at PeriRx. “Dr. David T. W. Wong at UCLA did a case-controlled trial comparing the salivary messenger RNAs in lung cancer patients and controls and developed a panel of 7 messenger RNAs that are discriminatory for lung cancer.”
Preclinical animal work supported the concept that tumors growing elsewhere in the body would affect what’s in the saliva as well as what’s in the blood. Then, Wong screened thousands of messenger RNAs in lung cancer versus control patients to determine and validate the 7 that were most abnormal. In fact, these 7 messenger RNAs already had been associated with lung cancer and measured in tumors.
“We’re doing the same type of study that we did with our oral cancer markers, which is not a case control study where you take people with known cancer,” Martin said. “You collect the saliva from patients before you know if they have lung cancer or not. Then a laboratory evaluates those markers completely blinded to whether or not the patient has lung cancer. We’re doing a trial right now.”
The research is underway at several different academic centers in Pennsylvania and Michigan. Recruitment is progressing quickly, though that’s because lung cancer is so prevalent. The company expects to complete recruitment by early in the first quarter of 2016. It then anticipates several months before the data is analyzed and ready for public disclosure, with a test available for practitioners after that.
Currently, low-dose CT scans represent the best means of diagnosing lung cancer. One study by the National Cancer Institute concluded that these scans have reduced mortality by 20%. However, the institute acknowledged concerns over cost, radiation exposure, and unnecessary lung resections for benign tumors.
“So in order to save 20%, how many patients without cancer undergo invasive procedures that have their own morbidity and even mortality?” Martin asked. “They concluded in that paper that biomarkers would become a valuable adjunct to CT scanning to help determine who you do the CT scan on, and if it’s abnormal, whether it’s time to take a piece of the lung out or not.”
Eventually, dental practitioners could administer a salivary test like PeriRx’s SaliMark OSCC to smokers and other patients considered to be at high risk for lung cancer right in their offices. Martin is optimistic that insurance companies would cover the care, too, considering the codes that are already available for the oral cancer screening.
“The ultimate goal would be to have a CMS code for that specific test in terms of making CT scans better,” Martin said. “That’s the kind of thing you have to work on hand in hand, in terms of arguing your case as to why this is a valuable test—not just cost-effective in terms of utilization of resources and avoiding unnecessary surgeries and CT scans—but also potentially lifesaving.”