Case Study 1



Clinician:
Dr. Richard M. Nelson
Oral and Maxillofacial Surgeon
Denver, Colorado






Patient:
64 year-old male, 1 pack/day smoker for 20 years.

Situation:
During my oral cancer examination, I detected a small, painless, red, ulcerated lesion on the floor of the mouth overlying the salivary duct. In the past, I would have watched this lesion to see if it would resolve or change. However, with the availability of the brush biopsy to evaluate harmless looking lesions, I tested it to rule out oral cancer.

OralCDx Analysis:
The brush biopsy result was positive, which warranted additional evaluation with an incisional biopsy.

Diagnosis and Treatment:
An incisional biopsy of the lesion was performed and the final diagnosis proved to be a squamous cell carcinoma in situ. The lesion was identified at an early stage and removed before it became a problem.

OralCDx Indications and Benefits:
As an oral and maxillofacial surgeon, I recommend that general dentists employ the brush biopsy tool for benign looking lesions that do not appear suspicious enough to refer to me: specifically, small white and red lesions that they see almost daily in their patients but do not ordinarily refer for biopsy.

Case Study 2





Dental Team:
Dr. Albert Castellan, GP Patti DiGangi, RDH
Chicago, Illinois





Patient:
51 year-old female, non-smoker, no known risk factors for oral cancer.

Presentation:
During a routine oral cancer examination performed by the dental hygienist, a smooth, nonulcerated, red spot that measured only several millimeters was noticed on the hard palate. The patient was unaware of its presence. It appeared harmless and resembled a pizza burn. The dentist performed an OralCDx brush biopsy.

OralCDx Analysis:
The OralCDx analysis revealed atypical epithelial cells requiring further investigation.

Diagnosis and Treatment:
The oral surgeon performed an incisional biopsy. The lesion proved to be dysplasia. The oral surgeon subsequently excised the lesion with adequate margins and no additional therapy was required.

Critical to Evaluate Everything: the Hygienist's Story:
This palatal lesion looked like something we see in our office almost daily - maybe a burn or a tortilla chip scrape. We thought it was probably nothing but since it didn’t have a cause, we knew we needed to evaluate it. The patient was more than grateful for the careful exam, for the ease of the brush biopsy, for the quick results, and for a procedure that saved her life – detecting a precancer before it was dangerous – before it could become a cancer.

Case Study 3

Clinician:
Rodney Steller, DDS
East Haven, Connecticut

Patient:
57 year-old male 
Non-smoker, no history of alcohol use

Presentation  
A 6 x 2 mm slightly raised white lesion on the posterior-lateral border of the tongue

Situation: 
During a routine six-month check-up, I noticed a very small white spot. It was situated on the lateral border of the tongue and to visualize it adequately, I had to extend the tongue as far laterally as possible. The patient was unaware of its presence, and the spot was not noted at his previous 6-month recall examination.  I looked for an obvious cause such as friction from a rough restoration or cusp but there was none. Although the lesion looked entirely innocent, I explained to the patient that I was going to test it to be safe.

OralCDx Analysis:
The OralCDx analysis revealed atypical epithelial cells warranting further investigation. These abnormalities are important since in approximately 1/3 of the cases, they indicate a precancerous or cancerous lesion.

Harmless-Looking but Potentially Dangerous: 
The patient’s oral cancer, like many oral precancers and cancers, appeared innocuous, and identical to common, harmless-appearing oral lesions that I encounter routinely. In fact, both surgeons had informed my patient that because I used the brush biopsy on a tiny, harmless looking lesion, the cancer was detected at the earliest possible stage when it could be cured by conservative therapy.  I now routinely test all tiny spots to be certain that they may not be potentially harmful.

Case Study 4

Clinician:       
Douglas T. Sakurai, DDS
Santa Ana, California

Patient:          
50 year old male
No history of tobacco

Presentation: 
Tiny, 5x5 mm white spot on the left lateral border of the tongue
.
Situation:       
During a routine dental visit, I noted a small white lesion on my friend’s tongue. The lesion was asymptomatic and not present at his last 6-month dental appointment. The lesion appeared entirely harmless: it was tiny, entirely white without a red component, thin and nonulcerated. Ordinarily, I would have had the patient return to “watch” the lesion. However, I was recently introduced by an oral pathologist to the OralCDx tool and elected to perform the brush biopsy procedure on my friend’s lesion.

OralCDx Result:
The analysis revealed atypical epithelial cells requiring further investigation.  Atypical epithelial cells are frequently the early signs of precancer. I showed my friend the hard copy of the Oral CDx report with color photos of the questionable cells and referred him to the oral surgeon.

Final Diagnosis and Treatment: 
Since the lesion appeared entirely harmless, my friend’s family physician was reluctant to send him to a surgeon. After 5 months, I finally persuaded him to refer my friend to a Head and Neck surgeon. Once again, the OralCDx report and referral were met with skepticism by the surgeon, but the scalpel biopsy was performed due to my insistence. The final diagnosis was a carcinoma in situ. A second surgical procedure was performed and the final deformity was minimal. The surgeon was amazed that a general dentist caught this lesion so early, and I looked like a genius.

A Friend’s Life Saved:
I found that the brush biopsy test was easy to use and cost effective, caused no discomfort to the patient, and took all of 5 minutes to administer. I now routinely brush biopsy all oral lesions, regardless of how small or "benign" they look. And when the report comes back “atypical”, I follow up to ensure that the lesion is subjected to a scalpel biopsy. After my friend had his surgery, he confided in me that his grandfather had died of oral cancer.  I honestly believe that without OralCDx in my arsenal, my friend may have experienced a similar fate.

Case Study 5

Clinician:
Dr. Jason Klingensmith
Greensburg, PA

Patient:
39 year old female with no risk factors; front desk coordinator for Dr.Jason Klingensmith
           
Presentation:
During an office brush biopsy in-service, the hygienist performed an oral cancer exam on the office staff and noted a spot in one of the officer workers. It was tiny and white, on the right lateral border of the tongue. Dr. Klingensmith confirmed the abnormality and performed a brush biopsy. 

OralCDx Analysis and Diagnosis:
The OralCDx report showed atypical cells warranting further investigation.  The patient was referred to a surgeon who performed a scalpel biopsy, which revealed dysplasia. The scalpel biopsy proved to be curative, and follow-ups after one month and six months showed no recurrences.

Comments:

Patient:“Sometimes I bite my tongue so I thought maybe that’s what it was. I have none of the risk factors, so I didn't think this could ever happen to me. Everyone should have their mouths checked regularly.”

Dentist: “It was so small, only 2x1mm, and it looked like it was an irritated area, maybe caused from the tongue rubbing against her teeth. Even the smallest of abnormalities in the mouth, no matter how insignificant you think it may be, can be more than what it looks like; this is a perfect example of that. That is why I test harmless-looking spots. "  It typically takes several years before a dysplastic oral spot can turn into an oral cancer, and during this time, the spot can be removed and oral cancer can potentially be prevented from even starting.

Surgeon: “It appeared totally innocuous; it looked like an irritation due to friction. Without risk factors, there was nothing to make one suspicious of a precancerous change. The brush biopsy is something we will use in the future in our practice.”

Case Study 6

Author:          
Dr. Stephen Frist

OralCDx Laboratories

Patient:          
32 year-old male 
Non-smoker, no history of alcohol use

Presentation  
A 3 x 2 mm flat, white lesion on the lateral border of the tongue

Situation: 
The dentist noted a tiny white spot on the tongue. Although the lesion looked entirely harmless and the patient was at low risk for oral cancer, the dentist tested the spot with the brush biopsy.

OralCDx Analysis:
The OralCDx analysis revealed atypical epithelial cells.

The Role of the CDx Computer: 
The brush biopsy slide contained over one hundred thousand normal cells and only a handful of abnormal cells. The identification of these abnormal cells is labor intensive, fatiguing, and time-consuming; more importantly, the abnormal cells are easily overlooked. At CDx Laboratories, these few abnormal cells, hidden among the normal cells, were identified by the CDx image analysis system that was optimized to detect oral precancers and cancers.
The OralCDx images of the selected abnormal cells presented to the pathologist identify cellular abnormalities that might otherwise have been missed with manual microscopic screening, optimizing the combination of human and computer capabilities. All pathologists at CDx Laboratories are specially trained in computer-assisted analysis of oral brush biopsy specimens.

Case Study 7






Clinician:
Howard Cobb, DDS
Chesapeake, VA





Patient:
39 year-old female, nonsmoker, nondrinker.

Presentation:
At a routine six month cleaning appointment, the patient remarked to the hygienist that the side of her tongue had felt irritated. Dr. Cobb noticed a tiny (2mm) white spot on the ventral surface of the right side of the tongue.

OralCDx Analysis:
The OralCDx results indicated that atypical epithelial cells were present. Dr. Cobb sent the patient to an oral surgeon, who reported that he "didn't think this lesion was anything significant and was not concerned about it." However, since the patient had been referred with an abnormal brush biopsy, he would excise the lesion.

Diagnosis and Treatment:
The histologic diagnosis was severe dysplasia. The patient has an excellent prognosis because of the attention and skill that her dentist displayed at her routine recall visit.

Benefits of Early Detection:
The oral surgeon was surprised upon receiving the final diagnosis. Until then, the several scalpel biopsies that he had performed as a result of atypical brush biopsies had been negative. He commented that this case had really opened up my eyes to the potential of the brush biopsy to detect precancerous lesions, especially when it was not even suspected. Dr. Cobb, who chose to protect his patient by testing a small, harmless - looking spot, transformed a routine recall visit into a lifesaver.

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"It didn't look like much. Since it was a small 2mm spot and it wasn’t clear what it was, I chose to use the CDx brush biopsy."
Dr. Howard Cobb

Case Study 8

Clinician:
Kevin Doring, DDS
Edgewater, MD

Patient:
42 year-old female, nonsmoker, nondrinker.

Presentation:
During a routine cleaning appointment, the hygienist noted a small white spot on the patient’s tongue. After carefully examining the patient and finding no cause for the abnormality, Dr. Doring performed an oral brush biopsy.

OralCDx Analysis:
The OralCDx results indicated no evidence of a precancerous or cancerous process.

“Going the extra mile for patients”
When I do my exam, the dental hygienist has already pointed out any abnormal spots to me. Usually the lesion has already been shown to the patient via our intraoral camera.  Then I’ll say, “"I see a small spot in your mouth and many of my patients have them. These spots are very common and almost always harmless.  Do you see it? Look, right here. It’s probably nothing, but I’d just like to be sure. I can do a simple test and find out very quickly whether or not it’s anything to worry about. If the patient asks, “Well, should I?”  I usually respond, “This is a painless test. I can tell you that if it was my mouth, I would do it.”  Then they say, “OK, go ahead, let’s do it.”  The lab portion will be paid by their insurance. The fee for the clinical procedure is not usually questioned.
The greater satisfaction is when I get the negative Test Report back and I call the patient to tell them that everything is fine, and emphasize that the testing was an important part of our commitment in protecting their oral health.  In those situations when the OralCDx analysis is “atypical,” I tell the patient that some cells were abnormal and not to be alarmed, but just to be safe, I recommend an excisional biopsy.  If the spot is precancerous, it can be removed years before it turns into a caner. Patients who get this report are grateful for the follow-up call and move quickly to the next step. Patients often tell all of their friends and family about the positive experience. 
Having the reputation as a practice that “goes the extra mile for patients” has made a significant difference in the way my dental team thinks about their jobs and the way our patients think about us. 

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“The oral surgeon called me to report… I probably saved this patient’s life.”
Dr. Craig T. Steicher
New Mexico

“The number one quality of OralCDx is the fact that I can do the procedure with minimal discomfort to the patients and get an accurate result.”
Dr. James C. Eich
Colorado

“OralCDx gives patients and me peace of mind. There is no reason to ‘watch’ questionable lesions any more.”
Dr. William Schneider
Maryland

“I feel it is my responsibility to examine all patients for oral cancer. I like the noninvasive, accurate results of OralCDx. It is a wonderful service to our patients.”
Dr. Ann B. Kirk
Massachusetts