OralDNA Labs, Inc, a new specialty diagnostics company focused on advancing existing and future laboratory diagnostic capabilities as they are applied within oral medicine, has been launched. Brian C Carr, a veteran of the clinical laboratory industry, will serve as President and Chief Executive Officer, while Dr Thomas Nabors will serve as Chairman and Chief Dental Officer.

Initially, OralDNA will provide science-based diagnostic and prognostic lab tests and data targeting periodontal disease to the dental community through a specialized sales force along with frequent speaking engagements from Dr Nabors and other periodontal disease experts. Company leaders anticipate that OralDNA will eventually provide a broad suite of molecular, genetic and other clinical tests to assist dental professionals in the screening, evaluation and treatment of other disease states.

Periodontal disease is present in an estimated three quarters of the adult population in the United States. If left untreated, this bacterial infection can lead to serious gum disease and tooth loss, and research now suggests a link to diabetes and cardiovascular disease. With more than 150,000 dentists and over 150,000 dental hygienists providing services within the United States, OralDNA has identified a large and underserved market.

"Under current practices dentists largely rely on visual and probing tools for the diagnosis of this disease, thus creating a situation where we not only are under-diagnosing but also under-treating the disease," said Dr Nabors.

"When a bacterial infection is present, it is important to understand the specific bacteria causing the disease progression so that a care provider can responsibly treat the patient. We now have the ability to utilize molecular diagnostics in dentistry just like our peers in the physician community use it to diagnose disorders such as Hepatitis, HIV and many other diseases."

OralDNA has introduced two test panels:
—  MyPerioPathsm is a DNA test focused on identifying the presence and
    bacterial load (quantity) of disease-causing pathogens associated with
    periodontal disease.
—  MyPerioIDsm PST(R), is a genetic test aimed at determining
    susceptibility to periodontal disease by analyzing the interleukin 1 genes.
    This test will be performed in-house by OralDNA under a license from
    Interleukin Genetics through a multi-year agreement between the companies.

The combination of these two important tests creates a systematic way to track and maximize clinical outcomes. They take the guesswork out of diagnosing and treating gingivitis and periodontitis, and the result is often a more productive and pro-active perio department within dental practices.

"We are excited to help lead the application of molecular and clinical laboratory testing to the forefront of dentistry," said Carr. "A disease that affects such a large portion of our population should be considered a high priority for aggressive intervention. OralDNA has the ability to help support advances by the dental community and, by implementing personalized medicine, create a more informed patient. Additionally, OralDNA is currently working to expand its test menu to support the dental community’s need for more laboratory-based diagnostic data."

Carr continued, "The Company expects that its primary test menu will be focused around using saliva as the specimen. Substantial ongoing research in both private and university settings is demonstrating that, in certain cases, saliva provides more sensitivity and specificity than blood or urine. In addition, saliva-based testing has many other important advantages: improved safety for healthcare workers, ease of obtainment, lower logistic cost with increased transport safety and stability, and excellent reproducibility. As a result, OralDNA believes that the emerging field of ‘salivary diagnostics’ will play an increasing role in laboratory and personalized medicine, not only in infectious disease, but also in cancer, cardiology and endocrinology. The impact could be dramatic as this fits a critical need in the U.S. for better access, lower cost, and a tailored approach to accompany therapeutic medicine. We believe OralDNA can play a key role in this evolution."

Joining Dr Nabors and Carr as a part of the executive management team are Sam Daniel, J Mark Farrington, and Robert P Walker, all of whom served key roles in building American Esoteric Laboratories, a clinical laboratory founded by Carr. Rounding out the executive team are Ken Clarke, who has served in multiple consulting capacities with Vanderbilt University Medical Center and was formerly with LabOne, and Russ Nabors, who has worked within the dental and healthcare industry for the last eight years. Serving as chair of the company’s Dental Advisory Board and in a consultative role is Dr Thomas Nabors III, DDS, an American Academy of Cosmetic Dentistry (AACD) accredited dentist practicing in middle Tennessee.

Oak Investment Partners led an investment consortium that joined with management in capitalizing OralDNA. Oak Investment Partners is expected to play an important role as the Company identifies potential acquisitions and seeks additional resources to scale the organization.

OralDNA Labs also announced that one of the world’s leading experts in molecular diagnostics and genetics, Dr. Ronald McGlennen, has joined OralDNA as its medical director.

"Dr McGlennen’s addition helps us connect the medical and dental communities," said Dr. Nabors. "The medical community has long used molecular and other diagnostic laboratory testing to improve diagnosis and treatment, and we can transport this experience to the dental community. As importantly, the medical community is beginning to establish a link between oral and systemic health and to explore testing within the oral cavity — the dental community can provide valuable insights in this effort."

"Our team has gone to great lengths in the development of this company to meet the same regulatory and quality control standards as other testing labs that serve the physician community," said Carr. "In addition to rigid U.S. federal and state clinical lab license requirements, including CLIA, we already have begun the process of becoming CAP (College of American Pathologists) accredited, which is a true signal of dedication to quality among lab professionals and physicians."

Source: MarketWatch