OralCDx BrushTest: Any Studies to Support Claims?

Dr. W asks:
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I have recently been bombarded with marketing from various sources, including the ADA, about the BrushTest from OralCDx. In addition, I have started to see marketing for this Brush test on buses throughout the New York City area. I vaguely remember seeing similar advertisements for this test over five years ago. I’m wondering if the test from OralCDx has undergone any changes or is the BrushTest similar to what OralCDx was marketing years ago?

From what I can recall, there was scant evidence that the test actually was useful. Have there been any new studies to support the claims for the BrushTest from OralCDx? I find it strange that a test which supposedly can prevent cancer needs to be marketed so heavily. If it works and is useful you wouldn’t need to advertise it. For instance, you don’t see similar advertisements for other cancer preventing tests, like colonoscopy or pap smears, because those tests are actually proven to be effective and beneficial. So, does anybody actually use the OralCDx test in their practice? What are you thoughts? Thanks.

Editor’s Note:
According to OralCDx:

“The OralCDx BrushTest is an easy, painless and definitive way for dentists to test the common small white and red oral spots that most people have in their mouth at one time or another. The BrushTest is used to determine if a common oral spot contains abnormal cells (known as dysplasia) that, if left alone for several years, may develop into oral cancer. The test is in use by over 30,000 U.S. dentists.”

4 thoughts on “OralCDx BrushTest: Any Studies to Support Claims?

  1. I believe the BrushTest is the same test from OralCDx from a few years ago. I don’t think it is new technology. Just seems to be marketed differently. I agree that there is very little evidence that the OralCDx test or similar tests have much value and so I’m not sure it’s something you need for your practice. Just refer out suspicious lesions.

    As for studies, the J Am Dent Assoc. 2008 Jul;139(7):896-905; had an article, “Adjunctive techniques for oral cancer examination and lesion diagnosis: a systematic review of the literature.”

    The authors concluded that: “OralCDx is useful in assessment of dysplastic changes in clinically suspicious lesions; however, there are insufficient data meeting the inclusion criteria to assess usefulness in innocuous mucosal lesions. Overall, there is insufficient evidence to support or refute the use of visually based examination adjuncts. Practical Implications. Given the lack of data on the effectiveness of adjunctive cancer detection techniques in general dental practice settings, clinicians must rely on a thorough oral mucosal examination supported by specialty referral and/or tissue biopsy for OPML diagnosis.

    Basically, as mentioned above. No real use for the test. Just refer out.

  2. If you go to the BrushTest website you will see that they were on the cover on JADA, that they did 30 studies at the biggest dental centers and they actually have themost studies ever done in dentistry

  3. There are some very interesting articles about the OralCDx test and its commercial relationship with the ADA over at: oral-cancer.info/.
    Below is one interesting quote.

    The main issue, as always, with research and seals of approval, is who paid what to whom. Unfortunately, the lines between real science and commercialism are sometimes quite blurry. In many of the studies, interestingly, there is a lumping together of Class I and Class II lesions, which skews results.

    More importantly, from a practical standpoint, one of the main issues with OralCDx is that according to the FDA, if the test is positive you must do a conventional biopsy. So the test is essentially completely redundant. Even though, the brush test has been around for years, it’s never caught on in dentistry in a big way for this reason and others, despite big marketing budgets. Bottom line is refer out.

    The author at Oral Cancer info says:
    “I’m a big believer that when the tide comes in all boats rise, and because of that, at least part of this program is a good thing. The words oral cancer and early detection are getting out there in the same sentence to an American populace that hasn’t even heard of the disease for the most part, let alone the need for early detection of it. But oral cancers are NOT like colon cancer that requires a polyp to exist before it can become full-blown cancer. Or cervical cancer that requires a persistent HPV infection prior to the development of a malignancy. To compare using brush cytology in the mouth, of visible lesions, to either of those is wrong. There is no “mandatory” oral precancerous lesion that always appears before manifestation of this disease. Many times even the primary disease itself can be occult and not visible, only detectable early through the palpation and touching of the tissues – feeling for indurations or hard spots, or in some cases the primary lesion is completely occult right up until a metastasis of the disease is discovered as an enlarged lymph node in the neck, and the primary is never found. A brush biopsy DOES NOT prevent this disease…

    Even Oral CDx literature (as required by the FDA) says that if you get a positive test result from them, you have to have it confirmed with a conventional biopsy anyway. If that is the case, generalists who are uncomfortable making the call should let the oral surgeon, oral medicine specialist, etc. make the call to biopsy or not when the patient is sent to them for a second opinion of any suspect tissue.

    I get it that this idea is to keep dentists from watching and waiting while a potential malignancy develops in the mouth, because this has been a problem with things for some time. Actually that has been a smaller problem than the fact that not enough dentists are actually doing opportunistic screenings on their entire patient populations at all. This brush system has been around for years and it has not won a place in dentistry in all that time. The fact is, that a general dentist, when he finds suspect tissues, is better served by sending that patient for a second opinion to an oral surgeon, or especially to an oral medicine specialist (they are usually not in private practice but at institutions like dental schools),than messing around doing an indeterminate brush biopsy. Dentistry has a well established referral system, and with the potential of a cancer prospering un-referred on their watch, which is deadly for the patient, and exposes the dentist to significant legal liability, this makes the most sense…”

    You can read more at: http://www.oral-cancer.info/?p=34, http://www.oral-cancer.info/?p=4, and http://www.oral-cancer.info/?p=47

  4. Blogs like this really don’t help dentists, and that’s a shame. Instead of providing useful information, marketers and professional bloggers fill us with doubt. Funny, I’ve never met other dentists that quote studies and point to websites like these folks. Well, fortunately, this is something that I know about. I’ve used the brush biopsy since 2004, and for me, it has a place.

    Someone commented that you have to do a scalpel biopsy if the brush biopsy comes back positive. Okay. So what. This isn’t double-jeopardy. If, during an oral exam, I see something that I can’t explain, I use OralCDx. Some of these spots are tiny (not exactly “lesions”). These are things that I would never have sent to an oral surgeon (and neither would most of you). It’s not supposed to replace a scalpel biopsy. It’s like a non-invasive “bridge” test between looking and the scalpel. It’s a way for me to tell which of my patients really needs a surgical biopsy. I don’t understand how dentists can make clinical decisions without more information. The brush biopsy provides me with something that I can’t get anywhere else – being able to speak with a dentist or pathologist at OralCDx about my case. Of course, if it is a lesion, it goes straight to the Oral Surgeon. No question.

    So, please do me (and everyone a favor) – if you’ve never tried the BrushTest and can’t speak first-hand, please don’t steer others away from it. And, not for nothing, but if “referring it out” worked so well, the mortality rate for oral cancer would have decreased…but it hasn’t. We should all be trying to provide better patient care. That’s our responsibility.

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