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For the first time there is now a "FDA APPROVED" HPV Genotyping test for HPV 16/18 on the market!
NOTE: This may change some follow up algorithms for patient care.
I imagine others may soon follow with FDA approval.
The one that was just FDA Approved, by Hologic, is found at:
http://www.cervistahpv.com/
As others are FDA approved we will mention them too!!!!!!
NCCC
GREAT news!!!!!
I hope they're able to get it out to the labs quickly....and get the doctors to use it!
And, I hope the FDA will approve genotyping for the other HPV types as well -- especially 31 & 45. Alan -- do you think the FDA is working on that? I'm concerned that the only reason the 16/18 genotyping test was approved is because researchers & clinicians & the FDA will want to follow the results/efficacy from the Gardasil vaccine -- although maybe also because those are the two most virulent strains.
But -- I think it could save money to know the type. For example, I briefly tested positive for HR HPV (no geno-typing), 21 months after my LEEP. My GYN used the standard HPV test. Since I had a new partner (4 months prior), I wanted to know whether I was testing positive for the same or a different HPV strain. The same strain might have meant persistent disease from my previous infection or recurrence, but a new strain might have meant transient infection from new partner. I then followed up with a type-specific test, which was not FDA approved and came back negative. Now I'll never know whether my virus is intermittently positive & negative or whether I breifly tested positive for a transient virus. This has implications relating to infectivity & how comfortable I am being intimate with my partner. Also, this uncertainty resulted in followup with an ECC, 2 vaginal & one cervical biopsy, because I was concerned about recurrence.
I don't understand why there has been resistance and reluctance to give people information about their HPV infection and why HPV testing has been limited to detecting CIN3 lesions. We know that most infections clear within a year or two and that it's persistent infection with the same HPV type that determines risk of progression. So... a protocol that involves routine HPV testing with type-specific followup, in my view makes sense, because any transient infections should clear quickly. The Gynecor HPV test cost less than $50 -- less than dinner & a movie. I think sexually active people would be willing to pay for this information if we were educated as to what it meant and what to do with the information.
I realize I'm ranting again about my favorite topic... Thanks again for the information, Alan, and we'll be looking forward to further FDA approvals!
flowershoplady -- I agree with you, and I'm planning to forward the test information to my GYNs.
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