NavDX Test-Can Be Misleading-Readings Can Be Opposite Condition-Giving False Hope Or Doom

wbcgaruss

Hello folks, I came across this on another forum of a fella who was getting Good NavDX Test readings and in fact, excellent NavDX Test readings but suddenly a recurrence showed up in his life again. I am reposting it here for informational purposes and discussion.

vpf143 says on Oct 3, 2023 • 3:22 PM

NAVDX - can be misleading

Diagnosed back in Jun 2022, with T1/N1 HPV+, tonsil cancer. Completed treatment in August (35 rads/3 cycles of chemo). My initial NAVDX test was 209 (Jun 22) and since then had NAVDX tests every 3-months, with my last one in Aug 23. Each one of them came back negative ( 0 ), which would suggest a 95% odd that you will not/not have a re-occurrence. My last CT scan illuminated a lymph node that was enlarged (1.8 cm) and needle biopsy confirmed positive for cancer, stained P16 (re-occurence).

Subsequently, called NAVDX to understand their explanation. I was informed the negative NavDx blood test could be the result of HPV integration into the tumor DNA instead of the HPV remaining separate in the episomal form which is more common. The NavDx test detects characteristic fragments of episomal HPV DNA that are released from dying tumor cells. In tumors with highly integrated HPV DNA, those fragments are generally not present.

Integration of HPV DNA into the tumor DNA is not/not uncommon. This illuminates that the NAVDX and how they are assessing a 95% detection rate is misleading.

Takeaway. The NAVDX is only a data point and should not/not be used as a substitute for traditional means of detection (scans, clinic scopes, etc). Despite their marketing strategy online, it has weaknesses that are not caveat in a manner that you would expect.

wbcgaruss

My response to this subject from vpf143 discussing his NavDX test was--

Since the NavDX test has been used more abundantly lately I still don't see their benefit. It is supposed to show cancer and detect it in the blood down to the DNA level which is awfully small. So then where are these positive microscopic DNA positive cancer detections coming from? You may have a very small tumor somewhere putting out this reading that never grows but there is always this worriment then that you see a reading in your blood from the DNA and really no discernable tumor of any size.

Also at this level you still need regular CT Scans with contrast and if you are showing an elevated NavDX reading or in my opinion a zero reading to be safe. And with traces of cancer DNA in your blood I have not seen them treat any of these cases with something like an immunotherapy it seems you are still obliged to wait till something gets big enough to show up on a scan before they can then identify it's location and type and treat you with conventional therapy such as surgery, radiation, chemo, or all 3.

Or you can be showing like this fella that had zero in his NavDX readings but still had a cancerous tumor show up then during a scan. This would be just as upsetting scenario as the first one I mentioned, maybe even worse because you feel good with the zero reading on the tests but are then shocked to find you have cancer again.

I am not sold on this test at all because there are too many variables and issues coming up where there is cancer and the test shows zero or cases where you live with a reading feeling that the cancer is in your body somewhere and you are just waiting for the next scan in fear that cancer will show this time. Way back in the old days, we didn't have the NavDX case and it seemed things worked well doing it that way. I believe this NavDX test and possible treatments may do an excellent job down the road somewhere I don't think they are dependable enough right now.

This is all just my opinion and what I have learned from reading information on it and following discussions on cancer forums.

I am sorry you ended up with a recurrence, I hope it is small and easily dealt with.

Wishing You the Best

Take care, God Bless

Russ

stickmanfob

What’s more concerning is this person had Stage1 HPV+ and it came back.

wbcgaruss

Well, it is certainly concerning but not completely unusual to have a recurrence or a completely new cancer show up.

The point the fella was trying to make though was he had cancer again but had NAVDX tests every 3 months, with his last one in Aug 23. Each one of them came back negative ( 0 ) so though the cancer was there the NavDx test was not showing it which is not the way I believe they advertise their test it is supposed to show cancer on a DNA level if there is any in the body.

He was upset and rightly so that a 0 test would suggest a 95% odd that you will not/not have a re-occurrence. So I am sure he was feeling confident he was cancer-free with the 0 test results.

But his last CT scan illuminated a lymph node that was enlarged (1.8 cm) and needle biopsy confirmed positive for cancer, stained P16 (re-occurence).

I know I would be upset with a 0 test rate that said nothing found and then find all along the reading was incorrect and I had cancer again. It would be a shock and devastating to get that news after supposedly good test results and after going through this brutal treatment we are subjected to.

This guy called the NavDx people and this is the explanation he was given...

Subsequently, called NAVDX to understand their explanation. I was informed the negative NavDx blood test could be the result of HPV integration into the tumor DNA instead of the HPV remaining separate in the episomal form which is more common. The NavDx test detects characteristic fragments of episomal HPV DNA that are released from dying tumor cells. In tumors with highly integrated HPV DNA, those fragments are generally not present.

So I agree with this guy that the Integration of HPV DNA into the tumor DNA is not/not uncommon. This illuminates that the NAVDX and how they are assessing a 95% detection rate is misleading.

And he goes on to say...

Takeaway. The NAVDX is only a data point and should not/not be used as a substitute for traditional means of detection (scans, clinic scopes, etc). Despite their marketing strategy online, it has weaknesses that are not caveat in a manner that you would expect.

So I think this just shows that there are inconsistencies in this test and the results you get from it and the fact that it is possibly not perfected yet and needs more refining but may well be one day closer to a perfect test. I think this is a good example of no matter what a test like this may say we still need the follow-up CT scans with contrast and PET scans in whatever amount your caregiver/provider feels is necessary.

Wishing You The Best

Take Care, God Bless

Russ

stickmanfob

I think the 95% is related to the time of the test. It says so on the NavDx.

I guess the concerning part is that the person had stage 1 HPV cancer and did all the treatments and it came back. Not sure what the recurrence percentages are for that but assuming somewhat low.

goffrey

https://csn.cancer.org/discussion/327133/navdx-test-can-be-misleading-readings-can-be-opposite-condition-giving-false-hope-or-doom

I think it is more concerning people are expecting the NavDx to be perfect. It has a 90% sensitivity rate and detects over 95% of recurrences and over 95% of remissions. Nothing is perfect, certainly not Pet Scans or CT scans. They miss as much if not more! Dental artifact, surgical changes and inflammation can make CT scans almost impossible to read correctly and give Pet Scans false positive and false negative results. Almost every major cancer center uses the NavDx, Mayo Clinic is using it in trials for de-escalation trials. The doctors who invented this test are highly regarded head and neck oncologists. It is saving lives every day. I have not had one Pet Scan come back with out uptake yet they have found no evidence of disease and my CT scans show dental artifact. But I am not stating they are useless are misleading, certain tests work better for different people.

wbcgaruss

goffrey, thanks for your input on this serious subject. I am not trying to down this test I guess I am overstating its shortcomings a bit too much. I realize it is depended on in a lot of places and the people who developed this test are certainly way smarter than me. If I got this test personally I would just keep in mind like everything else there could be a result that was not expected and that like everything else is not perfect. Again thanks for weighing in on this important subject.

Take care, God Bless

Russ