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New York State has a separate and unique regulatory approval process for laboratory diagnostic testing. PeriRx is currently in the application process with our SaliMark™ OSCC test and is vigorously committed to pursuing this application approval. 

Frequently Asked Questions About Oral Cancer

What is oral cancer?

Oral cancer, or oral cavity cancer, is cancer that starts in the mouth. Areas affected by this type of cancer are the lips, the inside lining of the lips and cheeks (buccal mucosa), the gums, the front two-thirds of the tongue, the floor of the mouth, and the bony roof of the mouth (hard palate). Oropharyngeal cancer starts in the oropharynx, which is the part of the throat just behind the mouth. This type of cancer can affect the base of the tongue (the back third of the tongue), the soft palate (the back part of the roof of the mouth), the tonsils, and the side and back wall of the throat. Most oral cancer begins in the flat cells (squamous cells) that cover the surfaces of the oral cavity. These cancers are called squamous cell carcinomas and account for about 90% of all oral cancers. 

How many people are diagnosed with oral cancer each year?

According to the Oral Cancer Foundation and the National Cancer Institute, approximately 47,000 people in the US will be newly-diagnosed with oral cancer in 2014. This includes those cancers that occur in the mouth itself, in the very back of the mouth known as the oropharynx, and on the exterior lip of the mouth.

What are the common risk factors for oral cancer?

  • Tobacco and Alcohol: Despite one’s gender, using tobacco in any form and heavy consumption of alcohol increases the risk of developing oral cancer.
  • Age: Two-thirds of all cases are diagnosed in people age 55 and older. This is most likely due to the cumulative effects of all the risk factors above over an extended period of time.
  • Gender: Oral cancer is twice as common in men than women. This may be because men are more likely to use tobacco and alcohol over long periods of time and in larger doses.
  • Occupation: Those with outdoor jobs who experience prolonged sun exposure are at greater risk for developing lip cancer.
  • Lifestyle: The sexually-transmitted human papillomavirus (HPV) puts people at increased risk for cancers of the oropharynx.
  • Diet: Some studies have found that people with diets low in fruits and vegetables tend to be at greater risk.
  • Betel Quid or Gutka: Chewing these products is also a risk factor for the development of oral cancer.

What are the symptoms of oral cancer?

The following symptoms and others may be caused by oral cancers, but it’s important to remember that other conditions may share these same symptoms, so always talk to your doctor if you experience any of the following:

  • A sore on the lips or in the mouth that does not go away (most common)
  • A persistent area of discoloration
  • Swelling or lump in the check, jaw or neck which does not go away
  • Pain or difficulty chewing, swallowing or speaking

For a more detailed list of potential oral cancer symptoms, click these links.

http://www.cancer.org/cancer/oralcavityandoropharyngealcancer/index

http://www.cancer.gov/cancertopics/wyntk/oral

How do I reduce my risk for oral cancer?

The best way to reduce your risk of developing oral cancer is to address the most common risk factors listed above.

  • Eliminate all tobacco use including cigarettes, cigars, pipes and chewing tobacco
  • Limit your intake of alcoholic beverages, especially hard liquor
  • Limit sun exposure and use a lip balm with sunscreen protection
  • Practice safe sex
  • Maintain good nutrition

How is oral cancer diagnosed?

The American Cancer Society and the American Dental Association recommend a thorough oral exam during routine dental and medical checkups. After determining the medical history and risk factors, the doctor or dentist will visually inspect the oral cavity and pharynx looking for abnormalities that may be suspicious to the eye.  They will also inspect for abnormalities of the lymph nodes in the neck. Abnormalities noted by the dentist or doctor may include unhealed sores, discolored areas including but not limited to red, white or gray patches, lumps, swelling or other problems.

If an exam identifies an abnormal or suspicious area, the doctor or dentist needs to decide if and when to refer the patient to an oral surgeon to remove a small sample of tissue (biopsy) from the area of concern. A pathologist then looks at the tissue under a microscope to check for cancer cells. A biopsy is the only sure way to know if the abnormal area is cancerous. Up until recently, the decision for a tissue biopsy was based solely on the visual appearance of the abnormal region and unfortunately it is often very difficult to accurately distinguish cancer from benign lesions in this fashion. Consequently, delays in diagnosing cancer are frequent and at the same time many of the biopsies that are performed turn out to be normal. The PeriRx salivary test for oral squamous cell carcinoma is a valuable aid to the practitioner in determining which lesions to send for an early biopsy and which ones to observe over time for possible natural resolution. 

What treatment is available for oral cancer?

Treatment usually involves surgery, but this depends on the stage and location of the cancer. Surgery may be followed by radiation or radiation in combination with chemotherapy. In advanced cases treatment is not always successful as up to 70% of the cases relapse and can result in death. The outcomes are more positive if the lesion is diagnosed early, but unfortunately symptoms and physical findings are often ignored and most oral cancers are diagnosed at a late stage.

For more information on treatment options click these links:

http://www.cancer.org/cancer/oralcavityandoropharyngealcancer/index

http://www.cancer.gov/cancertopics/wyntk/oral

What can be done to detect oral cancer earlier?

According to the National Cancer Institute there are over 8,000 deaths annually in the US attributable to oropharyngeal cancer. When detected early, the mortality rate for oral cancer is less than 10%, yet when diagnosed in later stages, the mortality rate is more than 50%. These statistics highlight the lack of sufficient screening that can provide potential cancer patients with critical early detection. As with most screenings, cost and convenience play a significant factor.

There is a solution: The PeriRx saliva test for oral squamous cell carcinoma is quick, convenient, and painless and can reduce overall costs by avoiding unnecessary biopsies. What’s more, because this test directs patients at highest risk of oral cancer to earlier definitive diagnosis, it may also reduce the amount of costly invasive surgeries, which can cause facial disfigurement as well as impaired speech and difficulty eating. Early detection of oral cancer is the key to positive patient outcomes and the PeriRx saliva test for oral squamous cell carcinoma is an effective facilitator of early detection and accurate diagnosis.

What is SaliMark™ OSCC?

SaliMark™ is a molecular DNA test that uses a patient’s own saliva to easily and painlessly assess the risk of oral squamous cell carcinoma.

How is this test used?

If an oral exam with the naked eye or fluorescent device identifies an abnormal or suspicious area, the clinician must decide if and when to refer the patient to an oral surgeon to remove a small sample of tissue (biopsy) from the area of concern. When this scenario occurs, the use of SaliMark™ OSCC can be instrumental in helping the clinician accurately assess the risk of the suspicious area in question and in turn, determine which lesions to send for an early biopsy and which ones to observe over time for possible natural resolution. In short, SaliMark™ OSCC provides two important patient benefits:

  • Reduces the incidence, expense, pain and potential disfigurement of negative biopsies
  • Increases the likelihood of early detection of oral squamous cell carcinoma, which can minimize the expense, pain and disfigurement that occurs with later stage treatment.

Why is SaliMark™ OSCC a breakthrough?

Up until recently, the decision for a tissue biopsy was based solely on the visual appearance of the abnormal region and, unfortunately, it is often very difficult to accurately distinguish cancer from benign lesions in this fashion.

How does this test work?

SaliMark™ OSCC utilizes molecules or biomarkers in saliva that reflect cancer activity and the combination of these marker levels provide the most accurate information available on the probability of cancer. Patients with a high-risk test result should be referred to a surgical specialist for consideration of biopsy. Patients with low-risk tests can be monitored closely and may subsequently need a biopsy if the lesion does not resolve or heal by itself.

Where was SaliMark™ OSCC developed?

Development of this simple-to-use, painless and noninvasive test was based on the strong scientific foundation of NIH-funded research with initial discovery and pre- validation work conducted by Dr. David Wong of the University of California at Los Angeles.

Is there supporting research?

Yes. More than a decade of National Institute of Dental and Craniofacial Research and National Institute of Health-supported research make SaliMark™ OSCC the world’s most scientifically-validated molecular DNA biomarker test for oral squamous cell carcinoma.

Does SaliMark™ OSCC test for the oral HPV virus?

No this test is not for the detection of oral HPV. Although specific strains of the oral human papilloma virus have been linked to various forms of head and neck cancer, there are two important facts that must be considered:

  • In the majority of cases, the oral HPV virus is eradicated by the body’s own immune system. Therefore, detection of the virus itself is not an accurate screening tool or risk assessment for actual malignancy.
  • Cancers attributed to HPV viruses occur primarily in the pharynx, not the oral cavity, and account for only about 10% of all head and neck cancers.
  • SaliMark™ OSCC is indicated for assessing the risk of visible lesions in the oral cavity. Cancer in this region of the body accounts for over 80% of all head and neck cancers, therefore, SaliMark™ is a more specific screening tool that can have greater impact on mortality rates.

Does SaliMark™ OSCC replace fluorescent devices?

No. If a practice has adopted fluorescent technology, SaliMark™ OSCC can enhance the effectiveness of that protocol by quantifying any suspicious lesions that are discovered during a fluorescent device examination.

How does SaliMark™ OSCC differ from other salivary tests that claim to be effective in detecting oral squamous cell carcinoma?

Unlike other salivary tests that claim to be accurate, SaliMark OSCC uses multiple biomarkers to provide the clinician with the most accurate risk assessment of suspicious lesions, excluding biopsy.

The result: A rigorous prospective blinded study found that SaliMark had over 95% sensitivity and over 99% negative predictive value in typical screening populations.

In fact, this level of non-invasive accuracy and efficacy is simply not possible using one biomarker.

How is the test administered?

Using SaliMark™ OSCC is very simple and can be explained in 4 steps:

  1. Upon detecting a suspicious lesion, have the patient spit into the collection tube.
  2. Seal the collection tube and place in pre-paid, pre-addressed FedEx envelope.
  3. The test will be FedExed to PeriRx’s certified lab for analysis.
  4. Lab results will be available in 72 hours.

How is the lab report interpreted?

SaliMark™ OSCC test scores are designated ads being low, moderate or high for the risk of oral squamous cell carcinoma.

  • Low-risk test scores optimizing sensitivity >95% have a negative predictive value over 99% in typical screening populations with <10% incidence of cancer
  • Moderate-risk scores identify patients for referral to a specialist (oral surgeon or otolaryngologist) for further evaluation and follow-up
  • High-risk scores identify patients for consideration of early biopsy

What’s more, because this test directs patients at highest the risk of oral cancer to earlier definitive diagnosis, it can also reduce the amount of costly invasive surgeries which can cause facial disfigurement, as well as, impaired speech difficulty eating.

How is the SaliMark™ OSCC test billed?

We suggest that the patient be charged when the test is performed. Patient claims can then be submitted for possible insurance reimbursement.

How is the claim submitted for reimbursement?

First, determine the level of service that you provided and select the appropriate CPT or CDT code. Either the provider or patient can submit the ADA Dental Claim Form or the CMS 1500 Medical Claim Form. Detailed information can be found on www.PeriRx.com.

Conclusion: Early detection of oral cancer is the key to positive patient outcomes and the SaliMark™ OSCC test for oral squamous cell carcinoma is the most effective facilitator of early detection and accurate diagnosis.