Enhanced Diagnostic Test for Oral Dysplasia and Cancer (OralCDx2)

Suffern, N.Y. – September 13, 2012 – CDx Diagnostics announced that it is launching an enhanced, second-generation, version of its powerful OralCDx test for the detection of oral pre-cancer and cancer at the annual scientific meetings of the American Association of Otolaryngology and the American Association of Oral and Maxillofacial Surgeons, both of which are being held this week.

The enhanced test, branded as OralCDx2, is the result of clinical experience with over 500,000 computer-assisted OralCDx oral brush biopsies, ten years of correlative experience with matching scalpel biopsies, and the inclusion of biomarkers, cell cycle analysis and HPV testing, all of which is correlated with the presence of abnormal cellular morphology.

The central benefit of OralCDx2 is an increase in the proportion of oral lesions for which a specific diagnosis can be made to 98 percent of all cases.
In addition to providing a definitive laboratory report, OralCDx2 abnormal findings are accompanied with a telephonic consultation from the laboratory that provides specific follow-up and prognostic guidance based on the combination of morphologic and molecular findings. 

CDx Diagnostics is upgrading all existing OralCDx test kits to OralCDx2 test kits at no charge. Both the clinician’s fee for performing the OralCDx2 biopsy procedure and the laboratory’s fee for its combined morphologic and molecular analysis of the resulting specimen are covered benefits of Medicare as well as virtually all private health insurance.

“Individuals already know that to prevent skin cancer they need to examine themselves regularly for moles and show them to their dermatologist so that precancerous cells can be ruled out,” says Wayne B. Eisman, M.D., F.A.C.S., president of ENT and Allergy Associates (ENTA), the largest otolaryngology practice group in the US, with over 100 ENT physicians in 38 offices.  “For the first time, they can also help to prevent oral cancer by regularly checking the mouth for white or red spots -- as small as a sesame seed -- and then pointing them out to their ENT doctor who can then rule out precancerous cells with a quick, painless, and minimally invasive test.  At ENTA, this program of patient self-examination combined with the OralCDx BrushTest is now helping to prevent this major, debilitating, and often deadly cancer.”

Dr. Steven A. Guttenberg, director of the Washington Institute for Mouth, Face, and Jaw Surgery, and former president of the American College of Oral and Maxillofacial Surgeons says, “Oral and maxillofacial surgeons (OMS) are continually faced with the challenge of determining if a routine appearing but unexplained oral tissue change is benign or dysplastic.  OralCDx2 provides the OMS with a rapid, minimally-invasive, definitive way to know how to treat these common lesions and I anticipate that it will soon become an essential component of routine OMS care."

Drore Eisen, M.D., D.D.S., medical director of CDx Diagnostics, adds, "Oral cancer is typically preceded by a visible white or red tissue change which contain dysplastic cells that could transform into an oral cancer. The challenge is that upon careful examination over ten percent of non-smoking and over 20 percent of smoking adults will be found to have a benign tissue change that cannot be clinically distinguished from one that is pre-cancerous. Only a biopsy of the entire thickness of the epithelium underlying the patient's white or red oral spot can determine that it is not pre-cancerous or cancerous.”

Eisen adds, “Because OralCDx testing provides a complete epithelial biopsy that is virtually painless and minimally invasive, it has already helped to identify thousands of patients with spots that contain precancerous cells before they could develop into oral cancer. By combining computer-assisted detection of abnormal cellularity with cell cycle analysis, the biomarkers of early pre-cancer and cancer, along with HPV typing and viral activity, we expect OralCDx2 to provide these life saving benefits to even more patients."

About OralCDx® BrushTest®
OralCDx® BrushTest® is an easy, painless and definitive way for doctors to test the common small white and red oral spots that most people have in their mouth at one time or another. The BrushTest is used to determine if a common oral spot contains abnormal cells (known as dysplasia) that, if left alone for several years, may develop into oral cancer. The OralCDx BrushTest is the only non-invasive test for oral pre-cancer and cancer. OralCDx® is part of CDx Diagnostics™.