I'm sorry I couldn't be clearer in my posts. I wish FDA would post the actual slides, which are presented as handy tables and much easier to understand than my notes. A couple of things:
In Phase 2b, there were no Day 4 samples tested by any lab. They didn't include a Day 4 in Phase 2b - only in Phase 1b. So none of the labs reported results for Day 4 in Phase 2b.
WPI's positive results on the "pedigreed negative control" were both from Day 0. One positive was from using their own PBMC PCR test and the other one resulted from using the NAT they were asked to run, also on PBMC. And the slide explained the problem with their Day 0 PBMC processing, which would have affected both their PCR PBMC and NAT PBMC positive results for the "pedigreed negative control" sample.
Note, however, that NCI/Ruscetti also got a positive result from this "pedigreed negative control" sample on their serology test, using the Lo/Alter method, but their positive was on the Day 2 sample, rather than Day 0. Although we didn't see specifics at the meeting, I would guess that WPI used their own serology test (maybe), rather than the Lo/Alter method, but we don't know yet (not reported) whether WPI's serology results once again found this "negative control" sample to be positive or on which day(s). But it's still good news, sort of, that WPI isn't the only lab that got positive results on the "pedigreed negative."
So, it will be interesting if WPI gets a positive result from the "pedigreed negative control" by serology, too. And, if they get a positive again, at least that result would be concordant with the NCI/Ruscetti positive result on the "pedigreed negative control" that was sent to NCI/Ruscetti directly from BSRI without WPI ever touching it. This scenario could leave us with 2 independent labs, using different methods, who both found this "pedigreed negative control" sample to be positive on at least some tests. aargh. There would definitely be some 'splainin to do.
FWIW, I'm not very happy with the small number of subjects/control in this study design either, but I don't do this kind of science, so I don't understand the reasoning behind why they did it this way. I've been learning a little about lab science, tho, and I'm hearing that many of these methods are still really time-consuming to perform and that running so many different types of tests on so many different "pieces" of the samples (e.g., WB, PBMC, plasma) has to require a lot of resources. So, maybe they only used 4 subjects and 1 negative control because they actually are in a hurry to get answers and this was the most efficient design to get them something they expected to be meaningful as soon as possible? But here we are in Dec., and all the labs STILL haven't finished all of the tests to be done. So, it's clearly much more complicated than they expected it to be going into this.
If I put on my "scientist hat," this is all really interesting. But when I put on my "Mom hat" with respect to my one really sick daughter and 4 other kids at risk and a brand-new grandson, this is driving me crazy!
We had decided to wait until after the meeting to have the blood draw to get my daughter tested by VIP Dx. I was hoping everything would be cleared up about testing by now, like we all did.
But I didn't learn anything at the meeting that has dissuaded me from going ahead with getting the test done. I already knew the VIP Dx testing wasn't FDA-approved (lol), I already knew the methods are still being researched and that I'd be paying out-of-pocket for results that we'd have to take with a grain of salt either way they come back. And, it certainly wouldn't be the first time I've spent a chunk of $$ on tests (and treatments and travel...) that had a lot less science behind them than this does. Obviously, that's only my personal view on this.
But in all seriousness, I think these and other questions in this thread are good questions, and I hope they will be answered tomorrow.
