Blood Test for MS Activity Gets FDA Brea... - My MSAA Community

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Blood Test for MS Activity Gets FDA Breakthrough Designation

BettysMom profile image
15 Replies

The US Food and Drug Administration (FDA) has granted breakthrough device designation to the Elecsys Neurofilament Light Chain (NfL) test for multiple sclerosis (MS). November, 2023

Made by Roche, the test is intended to be used as an aid in detection of disease activity in adults aged 18-55 years with relapsing-remitting multiple sclerosis (RRMS) or secondary progressive multiple sclerosis (SPMS), providing insights for disease management.

medscape.com/viewarticle/99....

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BettysMom
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15 Replies
AquaZumbaFan profile image
AquaZumbaFan

Wow!! This looks like a huge breakthrough! Thank you so much for sharing! ⭐️

CatsandCars profile image
CatsandCars

Thst could really aid in treatment decisions, although I just noticed it only goes up to age 55. Similar to the DMT studies. Hopefully it can still be used for older people as well.

BettysMom profile image
BettysMom in reply toCatsandCars

I'm wondering if that means that Medicare and other insurances won't cover it for those over 55 years old.

NanciG profile image
NanciG in reply toCatsandCars

Up until a few years ago, health departments didn't track data other than mortality on people over 55. I worked on a community project with our county health department 12 years ago and they had nothing. We had to go to individual health systems to get data and compile it ourselves. It was nuts. We are the invisible 29% of the US population.

CatsandCars profile image
CatsandCars in reply toNanciG

That is nuts. Especially when you consider how long some people can live.

CatsandCars profile image
CatsandCars

It might, especially private insurance. They seem to be worse than Medicare for me. But I guess we'll see.

mrsmike9 profile image
mrsmike9

Yay!

Cwright170994 profile image
Cwright170994

I really hope it gets released in the UK 🙏 I'm sure I'm advancing onto secondary progressive, given my rate of status epilepticus events these past few years 😫 I'm a bit of an odd case for my 1st neurologist, coming to him for simple partial seizures when I was 19 (they started when I was 18, and my GP didn't believe me or refer me to a neuro 😒). I was 19 when I got told I was having simple partial temporal lobe seizures, as well as a diagnosis of CIS MS. I was 21 (late 2015) when I had a relapse, and so a visit to the neuro and another MRI, I got a letter confirming I was clinically definite diagnosed with RRMS and epileptic. In 2020, I had the 1st of my generalised seizures, and then in April 2021, I had a night of a status epilepticus event. It got me hospitalised for 27 days, and me moving off copaxone onto ocrevus once my wbc count was high enough. I'm still having the status epilepticus events. I don't think I've had just the one seizure since that one in 2020 😬🤷‍♀️

BettysMom profile image
BettysMom in reply toCwright170994

Wow! You are definitely an odd case. It takes real fortitude to be able to deal with a seizure disorder that has become increasingly severe over time. Especially when you are also trying to treat MS. I wish the best for you and hope that medical science can find ways to lessen your burdens.

Cwright170994 profile image
Cwright170994 in reply toBettysMom

I know I'm odd in every aspect of my life, but the whole MS/epilepsy stuff is my greatest hit! That 1st neuro had never come across epilepsy being the 1st symptom of MS 🤣 I'm definitely wishing for a cure to all this, rather than having daily pills for the epilepsy and DMT for the MS 🙃. I believe the science people are looking into a vaccine to finally cure it, and other autoimmune diseases 🙌🙏 theepochtimes.com/health/ca...

mscalicima profile image
mscalicima

Thanks for the update. It is interesting it only lists to the age of 55. That is strange and annoying to us over 55 (by a bit in my case). ):

BettysMom profile image
BettysMom in reply tomscalicima

I haven't been 55 in long time.

kycmary profile image
kycmary

What are we who are over 55 suppose to do? They don't offer life ins for anyone over 84 either!

BettysMom profile image
BettysMom

It is probably only approved for people 55 and younger because that's where the data that was used for approval lay. But it won't do a great portion of MS patients any good if it is aged-limited to a young group. Since Roche will want to sell as much of this testing as they can, they will likely get more data using older people and reapply for approval with the FDA.

ahrogers profile image
ahrogers

Just have to find a lab that will run it. I asked my neuro about it in January and she said none of the labs in the area run it. She said here in the US it has pretty much only been used in clinical trials. I will have to ask again in July.Thanks for sharing!

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