I'm a retired biopharma & diagnostics medical director. I worked on the development & validation of a number of ctDNA/cfDNA assays that are used to monitor patients' responses to therapies and minimal residual disease burden. The Signatera assay, developed by Natera, and offered by FoundationOne, has very good clinical specificity, sensitivity and prognostic significance.. The assay relies upon the acquisition and construction of a patient's unique molecular genetic profiles from the DNA obtained from a tumor or lymph node. A patient' blood samples is then screened for the presence of cell tumor DNA fragments (ctDNA). It may detect new clonal .mutations as well. A high ctDNA score is indicative of recurrent/residual disease and potentiall a worse prognosisis. Your oncology team can use the information provided by the assay to adjust/modify/ change your therapeutic regimens to hopefully slow the progress of your disease.
There are a number of similar, if not superior offerings to Signatera from other clinical labs such as Quest's recently launched,Haystack MRD test, Guardant 360 MRD test, Circulogene's ctDNA/RNA test among others. All of these assays have minor variations in their respective sample prep, analyses and reporting of results. All appear to offer similar levels of sensitivity, specificity and prognostic significance as well as similar pricing. Their respective turn around times for reporting test results is variable, but is usually ~2 weeks.
My oncologist says if Signatera test shows cancer cells in blood, it's not clear what, if anything, to do about it.
Is this true for all or just for people with stage 1, grade 2-3?
ps I'm taking anastrozole & Kisqali (ribociclib), had surgery and radiation 8 months ago.
I have metastatic breast cancer and just got the results of my signatera test, in August my test showed .25 and in November the test results were .83 it was a positive test result. Can anyone tell me what this means?
I have metastatic breast cancer and just got the results of my signatera test, in August my test showed .25 and in November the test results were .83 it was a positive test result. Can anyone tell me what this means?
I have metastatic breast cancer and just got the results of my signatera test, in August my test showed .25 and in November the test results were .83 it was a positive test result. Can anyone tell me what this means?
Didn't your doctor or the Natera individual you work with contact you regarding this change? I would contact both with the jump in numbers. My oncologist messages me after the results are in.
I have metastatic breast cancer and just got the results of my signatera test, in August my test showed .25 and in November the test results were .83 it was a positive test result. Can anyone tell me what this means?
Waste of time and $$. I had the Signatera test done 7 times - every time in came back negative. But guess what? My TNBC had returned but the test said negative!!! No more Signatera for me and my oncologist agreed!!
@leolion811
So sorry to hear that. Is it ductal or lobular? Is it from the same site?
I was told that if there were cancer cells missed untreated at the original site, there may not be circulating DNA cells in the blood stream. In which case, the Signatera test would be negative...
So sorry ladies to read what you are going through. @davidwrenn had at great analysis of these types of test a while back. Both of you are coming at this test from completely different angles. My experience is a different viewpoint.
I have 2 different types of stage 4 cancer - breast since 2019 and the other - ovarian - percolating but only making itself known in late 2023/early 2024 when I got a brain tumor that was then biopsied. The docs have been using this test for several years BUT we have always considered it one tool in our toolbox. And never considered it the only tool. @arminda The test is first considered on basis of positive & negative for detecting any residual tumor makeup circulating in your blood. A tumor is needed to start the process, not blood nor ascites fluid which when tested can indicate cancer but not to the level of specificity needed. Then circulating is key word. So the test is seeing a little something. Perhaps an early warning. What now becomes important is trend - maybe another test or two to see if the last read was accurate or what kind of growth. We watched my latest go from negative to below 1 to 2, then 4 and now 8. But we used other tools like biopsies, tumor markers, scans, visual, health etc to now address my cancer again. So don’t be alarmed but be observant. Ask questions and just rely on it as 1 of several needed observations to then make some decisions. @leolion811 Sorry you are dealing with this journey again. Get the frustration. As I mentioned above, the tests are not perfect and just one early warning tool that good docs should follow and patients ask questions/get answers and advocate for themselves. I suspect that perhaps being localized might have impacted your results. The good thing is that you were using other methods to monitor yourself. No one should rely on only one test, bloodwork, scan, doctor opinion, etc in this process of determining whether one even has cancer, what is it and most importantly how much or yes how bad.
I am 6.5 years into my cancer journeys. I just had my 1st of 26th weekly chemo treatments yesterday. But I see my glass half full even as I start my now 4th time of dealing with it. I have an amazing life with speed bumps in it. The reality is everyone has to deal with speed bumps - ours are cancer. I just keep moving forward. Please do the same 🤗
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Thanks for the information. What do you think about the Personalis test? Also, I had Guardant Reveal, is Guardant 360 MRD a better test?
It has been helpful to me as my oncologist says it is a good "early warning" for recurrence and is more sensitive than ct scans.
My oncologist recommended it as an "early warning" for recurrence.
I have metastatic breast cancer and just got the results of my signatera test, in August my test showed .25 and in November the test results were .83 it was a positive test result. Can anyone tell me what this means?
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2 ReactionsIm unfamiliar with this test but am curious myself.
Didn't your doctor or the Natera individual you work with contact you regarding this change? I would contact both with the jump in numbers. My oncologist messages me after the results are in.
@arminda, welcome. I moved your question about Signatera test results to this related discussion:
- Signatera test, is it truly helpful and worthwhile? https://connect.mayoclinic.org/discussion/signatera-test-is-it-truly-helpful-and-worthwhile/
Do you have an appointment to discuss the test results with your doctor?
@leolion811
So sorry to hear that. Is it ductal or lobular? Is it from the same site?
I was told that if there were cancer cells missed untreated at the original site, there may not be circulating DNA cells in the blood stream. In which case, the Signatera test would be negative...
@leolion811 and @arminda
So sorry ladies to read what you are going through. @davidwrenn had at great analysis of these types of test a while back. Both of you are coming at this test from completely different angles. My experience is a different viewpoint.
I have 2 different types of stage 4 cancer - breast since 2019 and the other - ovarian - percolating but only making itself known in late 2023/early 2024 when I got a brain tumor that was then biopsied. The docs have been using this test for several years BUT we have always considered it one tool in our toolbox. And never considered it the only tool.
@arminda The test is first considered on basis of positive & negative for detecting any residual tumor makeup circulating in your blood. A tumor is needed to start the process, not blood nor ascites fluid which when tested can indicate cancer but not to the level of specificity needed. Then circulating is key word. So the test is seeing a little something. Perhaps an early warning. What now becomes important is trend - maybe another test or two to see if the last read was accurate or what kind of growth. We watched my latest go from negative to below 1 to 2, then 4 and now 8. But we used other tools like biopsies, tumor markers, scans, visual, health etc to now address my cancer again. So don’t be alarmed but be observant. Ask questions and just rely on it as 1 of several needed observations to then make some decisions.
@leolion811 Sorry you are dealing with this journey again. Get the frustration. As I mentioned above, the tests are not perfect and just one early warning tool that good docs should follow and patients ask questions/get answers and advocate for themselves. I suspect that perhaps being localized might have impacted your results. The good thing is that you were using other methods to monitor yourself. No one should rely on only one test, bloodwork, scan, doctor opinion, etc in this process of determining whether one even has cancer, what is it and most importantly how much or yes how bad.
I am 6.5 years into my cancer journeys. I just had my 1st of 26th weekly chemo treatments yesterday. But I see my glass half full even as I start my now 4th time of dealing with it. I have an amazing life with speed bumps in it. The reality is everyone has to deal with speed bumps - ours are cancer. I just keep moving forward. Please do the same 🤗
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Hug
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