It’s always great when there’s competition.

(Yes, I know the problem in America is that we no longer have capitalism- instead, our politicians have enshrined crony capitalism, where we grant favors to certain companies [and those are the ones that donate all those funds for their political campaigns].   But, it’s possible for us to re-enshrine capitalism as the partner for our democracy (there’s another institution that is endangered here in America, thanks to TheDonald and his buddies at qAnon)- so we really can re-stablish the American Dream, where anyone with a good idea, a little bit of luck and a lot of hard work can become successful.  But, enough about politics.  Let’s get back to science.)

So, some 10 days ago, we spoke about this AI-based test to discern if Alzheimer’s is setting in.  (The firm also claims it can help evaluate if those [probably worthless] brain function augmentation pills make a lick of difference.)  Well, Altoida seems to have some real competition now.

Fujirebio Diagnostics has also received FDA breakthrough device designation for its brand new in vitro (that means under glass- or really, not directly working on human living tissue) diagnostic device, called the Lumipulse G-β Amyloid Ratio test.  The system should be able to effect the early detection of amyloid plaques.  You know, those tangles that are associated with Alzheimer’s disease.   The device is aimed at 55 y old or older adults that manifest cognitive impairment.

This breakthrough designation was earned by examining some 292 CSF (cerebrospinal fluid) samples drawn from the Alzheimer’s Disease Neuroimaging Initiative Bank.  The samples were subjected to the Lumipulse test and compared with the results obtained from PET scans.  Of those with a negative PET scan (implying no Alzheimer’s involvements), 84% also were recorded negative results with Lumipulse.  But, more importantly, 97% of the positive Lumipulse results correlated with positive PET scan results

This device is intended to replace those expensive PET tests that I mentioned when we discussed the Altoida unit.

Now,  you should recall that these amyloid plaques are not inherently specific to Alzheimer’s; they do prevail in other diseases.   But, this device is a much cheaper alternative to the PET scans that have been used to detect the presence of amyloid plaques in the brain.  Moreover, the results are available on the same day as the testing and present no radiation risk (which is associated with the PET scans).

The Lumipulse measures the ratio of two specific proteins that are known to accumulate and form plaques associated with Alzheimers.  In particular, it’s the ratio of β-amyloid 1-42 and β-amyloid 1-40 in the CSF.  Positive tests are consistent with the presence of amyloid plaques, as would be discerned with the PET scans.

But, as I stated above, other neurologic conditions can also yield positive results, so other diagnostic analyses will have to be used to confirm Alzheimer’s involvement.

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