OralCDx®
Non-Invasive Oral Brush Biopsy with AI-enabled Tissue Analysis
A routine diagnostic test that empowers doctors to help prevent oral cancer and save lives.
OralCDx allows you to painlessly test any white or red spot in the mouth to rule out the possibility that precancerous cells are present.
If dysplasia is found, the cells can typically be removed in order to stop the progression of oral cancer.
Oral cancer is rising in low risk groups.
- Oral cancer kills about as many Americans as melanoma and twice as many as cervical cancer.
- Oral cancer is rising in women, young people and non-smokers.
- At least 25% of oral cancer victims have no known risk factors.
Finding oral cancer is too late
- By the time a lesion appears suspicious for cancer, it is generally dangerous, often life-threatening.
Mortality rates have not decreased in 50 years due to late detection.
Benefits of OralCDx®?
- Easy-to-perform
- In-office procedure - no need to reschedule patient
- Painless – well-accepted by patients
- Reliable – Clinically shown to be at least as sensitive as a scalpel in ruling our precancer or cancer.
Transepithelial Sampling
- Uniquely designed sampling brush allows for the collection of cells from the full thickness of the oral epithelium.
- The disaggregated specimen requires proprietary imaging and neural network algorithm to sift through the dense tissue to find potential abnormality.
- The brush biopsy requires no anesthesia, causes no pain and minimal or no bleeding.
Advanced AI-Enabled
Tissue Analysis
- An advanced neural network performs tests on every cell to detect hidden abnormalities.
- The proprietary technology has been adapted for optimal detection of cellular abnormalities that are unique to oral brush biopsy samples.
- The system identifies the most suspicious cells and cell clusters and highlights them for evaluation and diagnosis by specially-trained pathologists.
Why use OralCDx®?
Due to HPV and other factors, new demographics of patients are at risk for developing oral cancer.
Any oral lesion that does not have an obvious etiology such as trauma or infection is by definition “suspicious” and requires evaluation.
Since the majority of harmless-appearing red or white spots will most likely be due to trauma, OralCDx allows you to test your patients right in your office and only refer to a specialist when it becomes clinically necessary.
OralCDx can be used to reliably rule out the possibility that an oral lesion is dysplastic or cancerous.
How Oral Cancer can be prevented
Virtually every oral cancer starts, years earlier, as a harmless appearing precancerous lesion. Unfortunately, precancers cannot be readily identified by their clinical features since they resemble benign, small white and red lesions that physicians encounter daily.
Just like the Pap smear is used to detect precancerous cells to help prevent cervical cancer, and colonoscopy is used to detect precancerous polyps to help prevent colon cancer, OralCDx is used to detect precancerous cells in suspicious oral lesions to help prevent oral cancer.
The progression from dysplasia to cancer occurs over a relatively long period of time, typically several years, and during this time, the lesion can be removed and oral cancer potentially prevented.
The OralCDx® brush biopsy is easy to perform.
Because of the relative ease and practicality, every oral lesion can be tested at the time it is first identified, without the need to reschedule the patient.
Obtaining cells from all the layers of the epithelium down to the basement membrane is readily accomplished by repeatedly turning the brush in a clockwise direction until the mucosa at the site of the oral lesion turns pink or red, or until pinpoint bleeding is observed.
After obtaining the sample, the cellular material on the brush should be transferred to the glass slide provided in the OralCDx® kit, covered with the fixative that is supplied in individual packets and placed into the slide container supplied with the kit.
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