New Diagnostic Test - 4K Score

consultqd.clevelandclinic.org/2015/05/new-blood-test-is-highly-accurate-in-identifying-patients-at-risk-for-prostate-cancer/

I haven't seen this mentioned here as yet, so just thought i'd throw it out there.

According to the Opko website, the test is not yet FDA approved. But interestingly here is info on recommendation of NCCN...

clinical.opko.com/news/recommended-by-nccn-news

This could be important for newly diagnosed guys, and a big step in the right direction in avoiding overtreatment

Current cost is $400

CPT code 0010M assigned, but still termed "investigational."

Widely available, but Doctor office has to sign up to receive kits (basically just shipping containers with blue ice) in order to provide the service.



Here's the real paradigm shift, however: the whole point is that if your 4K score is low, you don't proceed to biopsy.

How do you think that'll go over at peer-support sites like HW/PC with a bunch of old guys who are generally resistant to change? My crystal ball says that the current faction who supports the "operate now, ask questions later" won't be supportive of the foundational basis of 4K which says NOT to biopsy men who may have an elevated PSA but have a low 4K score, even though they likely have indolent PC.

What thinkest thou of my posit?

JackH said...
Current cost is $400

CPT code 0010M assigned, but still termed "investigational."

Widely available, but Doctor office has to sign up to receive kits (basically just shipping containers with blue ice) in order to provide the service.



Here's the real paradigm shift, however: the whole point is that if your 4K score is low, you don't proceed to biopsy.

How do you think that'll go over at peer-support sites like HW/PC with a bunch of old guys who are generally resistant to change? My crystal ball says that the current faction who supports the "operate now, ask questions later" won't be supportive of the foundational basis of 4K which says NOT to biopsy men who may have an elevated PSA but have a low 4K score, even though they likely have indolent PC.

What thinkest thou of my posit?

The investtigational code has been lifted.

The American Medical Association (AMA) Current Procedural Terminology (CPT®) Editorial Panel has granted a Category I CPT code for the 4Kscore® Test. www.businesswire.com/news/home/20151112005826/en/OPKO-4Kscore-Test-Receives-Category-CPT-Code

The category 1 approval recognizes the 4Kscore as a established diagnostic test and addresses the important unmet medical need.

Category I: Procedures that are consistent with contemporary medical practice and are widely performed, and Category I codes are the five-digit numeric codes included in the main body of CPT.

The NCCN panel determined that the 4Kscore has a blood test with greater specificity over the PSA test as indicated for use prior to a first prostate biopsy or after a negative biopsy to assist patients and physicians in further defining the probability of high-grade cancer.

OPKO stated that: The code was published now, and negotiations with CMS and for Medicare as well as other providers have begun.

We should all practice saying these words:

From everything your doctor has reported, you probably have an indolent version of what today pathologists still call "prostate cancer." You probably have it because it is a ubiquitous condition which increases with age; nearly 50% of 50 year olds have it, 60% of 60 year olds, etc., and the vast majority will never be bothered by it. With the information you have, NOT proceeding to biopsy is probably your best choice, because a biopsy will probably do nothing but confirm that you have low-risk PC. With today's societal fears of the word "cancer," being labeled with that term puts one on a nearly unstoppable slippery slope toward PC overtreatment, which ran rampant in the most recent generation of men and ended up causing more harm than good.


Sounds pretty good. Will such counseling be effective?

sounds sensationalized...and from someone who is bitter about being over treated to me....

My main issues....with words like: Probably, majority, nearly and rampant....

All sensationalize and vague terms, which mean, there are going to be a % of men that will die from PCa choosing your route because they won't have treatment.

Again, having a biopsy isn't bad...it's MORE INFORMATION.

The key is education and promoting awareness....

Prato, this was discussed in several threads when it became available in 2014, possibly before you got here. You can use the search feature to find more discussions.

4Kscore released in US -price?

The problem I have with it is cost - something around $400 and it is not FDA-approved (i.e., not covered by Medicare or most insurance companies). It measures 4 kallikreins (Total PSA, Free PSA, Intact PSA and Human Kallikrein 2 (hK2)). In that sense, it is similar to PHI, which measures a kallikrein called -2(ProPSA) in addition to PSA and % free PSA. In validation studies, 4Kscore and PHI have about the same accuracy in detecting PC (neither is terrific).

Comparison Between the Four-kallikrein Panel and Prostate Health Index for Predicting Prostate Cancer

PHI is FDA-approved, has been well validated (it's was approved in Europe years earlier), is covered by Medicare and most insurance, and the cost is only about a quarter of the cost of 4Kscore. So why pay more to get the same thing?

- Allen

Post Edited (Tall Allen) : 12/21/2015 10:44:25 AM (GMT-7)

I agree with Mel, for the most part I have seen change much more tolerated here. Obvious exceptions noted!!!

If I could change one thing with the prostate cancer treatment pathway, it would be to make it so difficult to have surgery if you are a minimalist G6er. At HW we see small percentage of small core numbers of G6 on the way to the Magic Machine. It should be just short of criminal to do that to someone. What happened to "First Do No Harm"?
Hero

jpenn44 said...
... I think we as a peer support group have done a nice job of educating them on ALL treatment options.....

I will agree wholeheartedly. I found HW, asked questions and got great answers. Have done a lot of reading here and learned a great deal here.

After four months here, have still not had a biopsy and may go much longer. As for a biopsy not being "bad" the seven percent that have infections from biopsy may not fully go along with that. Risk of infection and ensuing antibiotics are my reason for not wanting a biopsy needlessly. And a blind biopsy doesn't really tell you anything definitively.

I think a big part of what people come here looking for is definitive answers. We don't really see definitive negative answers pre-treatment. And when you have positive answers you have to go for a second opinion which may or may not score up or down.

Maybe that's part of the rush to surgery "At least we got it out" and it can't be a problem. Which is not necessarily the case.

There is clearly a market for any definitive pre-biopsy, non-invasive diagnostic procedure, and probably a wide and deep market at that. If some test becomes the standard over and above PSA test for PCa, that will create a huge revenue stream.

We are all looking for answers, but in the case of PCa they are all to often not definitive.

compiler said...
Jack:

Why do you characterize HW as consisting of a bunch of old men resistent to change?? Some resistance comes with the territory of being old. But I see HW folks as being far less resistent to change than your average non internet-savvy PC patient.

You need to re-evaluate

Mel

No, I don't think so. There is a lot of attitude similar to "it was good for the goose, so it must be good for the gander." Hey, I never said that change wasn't difficult...