RICE (US)—A test that uses a new diagnostic nano-bio chip is as effective and far more expedient in detecting oral cancer than traditional invasive lab procedures.
Oral cancer afflicts more than 300,000 people a year, including 35,000 in the United States alone. The five-year survival rate is 60 percent, but if cancer is detected early, that rate rises to 90 percent.
Preliminary studies by researchers at Rice University, the University of Texas Health Science Centers at Houston, and San Antonio and the University of Texas M.D. Anderson Cancer Center found that the test was 97 percent “sensitive” and 93 percent specific in detecting which patients had malignant or premalignant lesions, results that compared well with traditional tests.
“One of the key discoveries in this paper is to show that the miniaturized, noninvasive approach produces about the same result as the pathologists do,” says John McDevitt, the Brown-Wiess Professor of Chemistry and Bioengineering at Rice University.
McDevitt and his team are working to create an inexpensive chip that can differentiate premalignancies from the 95 percent of lesions that will not become cancerous.
The study appears online in the journal Cancer Prevention Research.
The minimally invasive technique would deliver results in 15 minutes instead of several days, as lab-based diagnostics do now; and instead of an invasive, painful biopsy, the new procedure requires just a light brush of the lesion on the cheek or tongue with an instrument that looks like a toothbrush.
“This area of diagnostics and testing has been terribly challenging for the scientific and clinical community,” says McDevitt. “Part of the problem is that there are no good tools currently available that work in a reliable way.”
He said patients with suspicious lesions, usually discovered by dentists or oral surgeons, end up getting scalpel or punch biopsies as often as every six months.
“People trained in this area don’t have any trouble finding lesions,” McDevitt says. “The issue is the next step—taking a chunk of someone’s cheek.
“The heart of this paper is developing a more humane and less painful way to do that diagnosis, and our technique has shown remarkable success in early trials.”
The way forward is with nano-bio-chips—small, semiconductor-based devices that combine the ability to capture, stain and analyze biomarkers for a variety of health woes that also include cardiac disease, HIV and trauma injuries.
The new study compared results of traditional diagnostic tests with those obtained with nano-bio-chips on a small sample of 52 participants, all of whom had visible oral lesions, leukoplakia or erythroplakia and had been referred to specialists for surgical biopsies or removal of the lesions. Of those patients, 11 were diagnosed as healthy.
The chips should also be able to see when an abnormality turns precancerous. “You want to catch it early on, as it’s transforming from pre-cancer to the earliest stages of cancer, and get it in stage one.
“Then the five-year survival rate is very high,” McDevitt says. “Currently, most of the time, it’s captured in stage three, when the survivability is very low.”
The device is on the verge of entering a more extensive trial that will involve 500 patients in Houston, San Antonio and England. That could lead to an application for FDA approval in two to four years.
Eventually, McDevitt says, dentists may be the first line of defense against oral cancers, with the ability to catch early signs of the disease right there in the chair.
The study was funded by the National Institute for Dental and Craniofacial Research Division of the National Institutes of Health.
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