Wednesday, March 3, 2010

ORALDNA® LABS INTRODUCES ORARISKsm HPV SALIVARY DIAGNOSTIC TEST TO HELP DENTISTS ASSESS THE RISKS OF CERTAIN TYPES OF ORAL CANCER

At the Midwinter meeting, there was some major buzz surrounding OralDNA labs and their ability to identify things through simple tests. Fairly amazing stuff that may change the profession. Read on for details:

Nashville, TN – February 26, 2010 – OralDNA® Labs Inc. (www.OralDNA.com), 
leaders in advancing wellness in dentistry through salivary diagnostics, and a subsidiary of Quest Diagnostics® Incorporated (NYSE: DGX), recently introduced its OraRisksm HPV test, a non-invasive, easy-to-use screening tool to identify the type(s) of oral human papillomavirus (also called HPV). Oral HPV is a mucosal viral infection that is a known risk factor for oral, head, and neck cancers. High-risk types of HPV that persist present an increased risk for cancers in these regions. This test will provide the dental clinician with the ability to establish risk for HPV-related cancers of the oral, head, and neck regions and determine appropriate referral and monitoring conditions.

Squamous cell carcinoma of the head and neck (SCCHN), which can be found in the oral cavity, tongue, tonsils, oropharynx, and larynx, affects approximately 40,000 individuals in the United States each year.1 The most common symptoms of SCCHN include sore throat, earache, hoarseness, and, quite often, enlarged lymph nodes in the neck. Early detection of oral HPV presents an important opportunity to detect those at risk for these types of cancers before symptoms appear.

According to OralDNA® Labs’ Medical Director Ronald C. McGlennen, MD, “The availability of the OraRisksm HPV test marks an important and timely advance in oral diagnostics, because the at-risk profile for oral cancer is rapidly changing.”

The use of tobacco and heavy alcohol consumption have traditionally been considered to be the primary risk factors for SCCHN, but an alarming number of new cases are being diagnosed each year among persons who do not fit the tobacco and alcohol user profile.1

“In fact, a new high-risk profile for SCCHN has emerged,” explains Dr. McGlennen. “Recent research studies have identified several high-risk strains of the human papillomavirus (HPV), especially the variant known as HPV-16, as potential etiologic agents in the development of SCCHN.”

It is now estimated that 50% of all diagnosed cases of oral cancer in the United States are attributed to the HPV virus.4 It has been well documented that HPV transmission is associated with sexual contact, with the risk of contracting HPV higher among those with multiple sex partners.

“Oral HPV is a silent, serious infection that can now be detected and closely monitored by the dental professional,” states OralDNA® Labs’ Chief Dental Officer, Thomas W. Nabors, DDS. “Specifically, the laboratory report derived from the OraRisksm HPV salivary diagnostic test helps dental professionals identify the specific types(s) of oral HPV present, as well as the associated risk profile for each type of HPV variant detected in the patient’s oral cavity.”

Strong candidates for the OraRisksm HPV test include patients with the following profile characteristics:

• Sexually active
• Family history of oral cancer
• Signs and symptoms of oral cancer
• Traditional risk factors for oral cancer
• Suspicious oral lesions

Innovative salivary diagnostic tests from OralDNA Labs are fundamental elements of a patient’s wellness plan. OraRisksm HPV is the third molecular salivary DNA test that OralDNA® Labs has introduced to the dental profession in less than a year. In 2009, the company launched two tests for periodontal disease named MyPerioPath® and MyPerioID® PST®.

Specifically, MyPerioPath® identifies the type and concentration of specific perio-pathogenic bacteria that are known to cause periodontal disease and helps support clinicians with better risk assessment and personalized treatment options for more predictable patient outcomes.

MyPerioID® PST® identifies an individual’s genetic susceptibility to periodontal disease and enables clinicians to establish which patients are at increased risk for more severe periodontal infections due to an exaggerated immune response.

For more information, education, and training related to OralDNA®’s salivary DNA diagnostic tests, dental professionals, including periodontists, general dentists, and dental hygienists, should visit www.OralDNA.com/training or call (877) 577-9055.

About OralDNA® Labs Inc. (www.OralDNA.com)


OralDNA® Labs Inc., a subsidiary of Quest Diagnostics® Incorporated (NYSE: DGX), is a leader in advancing wellness in dentistry through salivary diagnostics. The company’s goal is to help the dental profession achieve better clinical outcomes by providing reliable, definitive, and cost-effective clinical tests that drive the detection and prognosis of disease at an earlier, more treatable stage. Innovative salivary diagnostic tests from OralDNA® Labs are fundamental elements of a patient’s wellness plan. OralDNA® currently offers three DNA-Polymerase Chain Reaction (PCR) tests for periodontal disease and oral HPV:

MyPerioPath® identifies the type and concentration of specific perio-pathogenic bacteria that are known to cause periodontal disease and helps support clinicians with better risk assessment and personalized treatment options for more predictable patient outcomes.

MyPerioID® PST® identifies individual genetic susceptibility to periodontal disease and enables clinicians to establish which patients are at increased risk for more severe periodontal infections due to an exaggerated immune response.

OraRisksm HPV is a non-invasive, easy-to-use screening tool to identify the type(s) of oral HPV, a mucosal viral infection that could potentially lead to oral cancer, and in turn, enables the clinician to establish increased risk for oral cancer and determine appropriate referral and monitoring conditions.

About Quest Diagnostics®
Quest Diagnostics® is the world's leading provider of diagnostic testing, information, and services that patients and clinicians need to make better healthcare decisions. The company offers the broadest access to diagnostic testing services through its network of laboratories and patient service centers, and provides interpretive consultation through its extensive medical and scientific staff. Quest Diagnostics® is a pioneer in developing innovative new diagnostic tests and advanced healthcare information technology solutions that help improve patient care. Additional company information is available at www.QuestDiagnostics.com.

References:

1. Haddad RI. Human papillomavirus infection and oropharyngeal cancer. Medscape CME Website. http://cme.medscape.com/viewarticle/559789. Published July 17, 2007. Accessed December 4, 2009.
2. Mork J, Lie K, Glattre E, et al. Human papillomavirus infection as a risk factor for squamous-cell carcinoma of the head and neck. N Engl J Med. 2001;344:1125-1131.
3. Kreimer AR, Clifford GM, Boyle P, Franceschi S. Human papillomavirus types in head and neck squamous cell carcinomas worldwide: a systematic review. Cancer Epidemiol Biomarkers Prev. 2005;14:467-475.
4.

Saraiya M, Kawaoka K. Incidence of human papillomavirus (HPV)-related head and neck cancers in the US from 1998-2003: Pre-HPV vaccine licensure. Proc Am Soc Clin Oncol. 2007;25:299s.
5. Schwartz SM, Daling JR, Doody DR, et al. Oral cancer risk in relation to sexual history and evidence of human papillomavirus infection. J Natl Cancer Inst. 1998;90:1626-1636.

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