Should have read "Ag/Ab". As I understand it, antigens do appear in oral fluid, so if we were to discover that CEMI had a viable OF Ag/Ab test, that would game changing.
With CDC's recommended change in guidelines last month, it's imperative that CEMI have a workable test in the offing. If not, that could constitute LS' worst failing. Determine Combo has been on the market overseas for a couple of years now, so it's not as if this was a surprise. LS always clung to the idea that Determine Combo wasn't a very good test, but ALR was going to find ways to improve it.
Spurzel has been very quiet. Clearly, there's lots of quiet work to be done. I think the goal is fix this up, a job requiring about 8 to 12 months, and then begin to make acquisitions.
The administation has seeded at least 300,000 latent TB carriers and 30,000 active cases all around the US. Children with active cases of TB WILL be showing up in schools next month. TB is about to become endemic once again in the US. Question is, does CEMI have a test in the works which outperforms the current one? That would be a big deal.
You write as if you're on a first-name basis with the former ALR CEO. I do agree that there will be big changes at ALR. However, CEO searches take many months, as we've seen. Then, the new CEO will need time to study the company's operations. Then, if there are to be divestitures, that will make many months more. We're probably looking at up to two years before anything of significance happens at ALR.
Spurzel has his hands full cleaning up the mess left by LS, specifically as regards to failure to win timely approvals, the failure to bring new products to market, and the failure to create a DPP licensing revenue stream. The fact that CEMI doesn't have a DPP Ag/Ab or a DPP HCV product ready is particularly glaring.
I could not find any reference on various Alere web pages to the fact that Determine Combo is not waived. Alere's strategy seems to be to ignore that fact. Does the FDA care that Alere is pretending the product has a waiver already? Probably not.
The only competitor in the HIV-Syph diagnostic space is, you guessed it, Alere (which owns a majority stake in SD Bioline).
Here's a quick account of SD acquisition in 2010. Alere paid $206 million for a 78% stake. SD's 2010 revs were $79 million, which means that SD was valued in 2010 at around $264 million, ie 3.3 times revs. That was in 2010. The equivalent valuation of CEMI would be about $8 a share, although prices have certainly gone substantially higher since then. I'm beginning to see why Spurzel took this job. A few tweaks and this company is going to be worth $10.
Just looked up the stats. MTCT of Syph alone results in 215,000 stillbirths, 90,000 neonatal deaths, 65,000 pre-term births, and 150,000 congenital infections every year. The failure to test and treat Syph alone is affecting half a million fetuses/newborns every year. There's definitely a global effort gearing up to deal with this problem.
Two researchers from the JH infectious disease division just published a piece lamenting the absence of an accurate POC test for Syph. Are they sending a message to the FDA, which has steadfastly refused to approve new tests?
That's elimination of mother-to-child transmission (of HIV and/or syphilis). Just published a report and setting up global infrastructure to do this.
Report was published this month. I'm going to guess that a big push for donor-funding will follow.
EXAS has been a real winner, but probably prudent to take some gains there. CEMI seems to want to go up, despite the total lack of positive news. Could the turnaround be already underway?
ALR's decisions basically led to LS' "retirement". First, they sold the block of stock. Then, they "surprised" CEMI with the Determine Combo approval. Then, they refused to make a decent offer with regard to Stat-Pak. So, if their intention was to see LS sent packing, they certainly accomplished that goal. Of course, we don't know the personal history between LS and Avi, but clearly no love lost there.
So, now ALR finds itself in a situation where it's customers are, at a minimum, greatly inconvenienced. Also, they'll take a short term revenue hit. They're clearly dealing with a CEO in Spurzel who is not going to roll over and play dead. Of course, this is all more-or-less irrelevant as far as ALR is concerned. Small potatoes.
We still don't have a good sense of when CLIA waiver for Determine Combo might be given. Could be tomorrow. Could be many months. CEMI has to use this time, especially once ALR's Stat-Pak inventory is gone, to identify ALR's customers and distributors. Have to move with dispatch.