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.
It's increasingly clear that two things could propel CEMI much higher. First, if it becomes clear that CEMI will get approval for DPP HIV. Second, if CEMI has an effective DPP HCV test in the works. I think DPP HIV-Syph is a dead letter in the US.
Spurzel is clearly still in fix-it mode. When he begins to book conference appearances, I think you'll know that the turnaround is truly underway.
You have no idea what you're talking about, which is nothing new. You don't even understand the nature of the problem. More public health agencies are recommending an algo which includes a test for acute infection. This is because patients are most infectious during the first few weeks. That's why there will be demand for an Ag/Ab POC test...if it works.
That's the big question with Determine Combo. If it catches 55% of acute infections, well, that's better than nothing. OTOH, it misses 45%, which means a large number of positive patients may falsely believe that they are HIV free. False negatives aren't good when it comes to infectious disease.
Second is the issue of the "faintness" of the lines. Are lower skilled HC workers really going to be able to figure out what's positive and what's not.
Whatever happens, I think you're right in that this study provides ammo for those who would question Determine Combo. Assuming ALR gets its CLIA waiver, its reps are going to have lots of explaining to do. Market acceptance might very well be slow in coming.
I think there are two very serious issues as regards Determine Combo. First, it only ID's slightly more than half of acute cases. If a patient with acute infection is told they have no infection, which will happen in 45% of Determine-tested patients, they might engage in high risk behavior at precisely the time that they are most infectious. This, in my view, may be a worse outcome than having the patient wait a couple of weeks. The FDA should very seriously consider this issue.
Second, and perhaps even more problematic, is the issue of "faintness" on the Ag line. How is a low level health care worker supposed to know whether a faint line indicates positive or negative. Perhaps they don't see the line at all. This, seems to me, a big problem as regards the CLIA waiver. However, Determine sailed through the FDA on sketchy data, and they'll probably sail through CLIA process with big questions left unanswered.
Aside from the fact that Architect dominated Determine, there are a couple of points that do cast doubt from a CLIA perspective. A health care worker with low level of training might tell a patient with acute HIV infection but that who tested negative on Determine that they were HIV-free. This might lead the patient to engage in high-risk behavior, which could then expose others. Also, the Ag line apparently shows up very lightly at times. Could a low level health care worker really determine whether that was a positive or a negative? That's a big issue as regards CLIA waiver, since the main point is ease of use. If you can't read the results clearly, that would seem to be disqualifying.
How so? Determine Combo detected 31 of 58 acute cases, which is not nothing. Of the 31, 13 were antigen-only. I'd be interested to know whether DPP HIV could detect more of the Ab + acute cases than the other tests used in the study. Even so, it's clear that Determine Combo will pick up some acute cases missed by the other tests. It's imperative the CEMI develop its own Ag-Ab test using DPP technology. Since Determine Combo has been around for several years, it's really inexcusable that CEMI doesn't have one yet. If that's related to technical issues, fine. If it was an executive decision, it's yet another LS fail.
Determine's problem is that the Architect Ab-Ag test massively outperformed. Are the advantages of POC testing important enough to forego the enhanced accuracy of lab testing? I don't really know the answer to that question.