If all goes as planned, GW Medical Technologies (Phoenix) expects to have a blood test for Alzheimer's disease (AD) on the market in the U.S. by late 2006.
If approved, it would be the first such blood test on the market and the very first FDA-approved for AD.
The company reported last week that it had launched a pilot study to verify its prior positive results and make final preparations for clinical studies required by the FDA before it submits a premarket approval application, also in the latter part of 2006.
Don Weber, GW Medical's vice president of licensing, told Medical Device Daily that the test was developed at the University of Leipzig in Germany. GW Medical's business model is centered on taking an institution's technology that is patented, or that of an affiliated institution, and moving it to the marketplace.
The LymPro test, he said, quantifies AD "disturbances" of intracellular mitogenic signaling by measuring presentations of an activation inducer molecule – named CD69 – at the surface in peripheral blood lymphocytes, with and without mitogenic stimulation.
"What we are looking at is forms of protein expressions on the cells that would be indicative of this particular disease," Weber said, "and we've done that by looking at what we call very low levels of protein expressions on the cell surfaces and comparing those expressions against known healthy individuals vs. those who may have the condition of Alzheimer's."
The new study is being conducted as a retrospective blind test with samples from healthy participants, those with AD, as well as patients with other dementias, the company said. It expects that the results will "demonstrate the LymPro Test's strong correlations with clinical diagnosis."
AD has no cure, and thus far no definitive diagnostic for the living. Absolute diagnosis of AD can be made only after death, when the brain can be examined. Until such time, an individual is determined to be only "AD-probable," Weber noted.
Another company, Nymox (Maywood, New Jersey), has a urine test for AD that has U.S. CLIA approval and the CE mark , though no FDA approval as of yet.
The LymPro test is meant to be used along with other diagnostic tools currently used by physicians, such as the MEMSA test and a smell test, since, as Weber said, loss of the sense of smell is one of the first symptoms that a patient may experience in the beginning stages of AD.
"We have a series of studies," Weber said, "that we will undertake on this particular test to get it to the ultimate point of being a true screen for Alzheimer's disease [so] that it will be able to say 'yes.' As it stands now, we believe that the product has that capability, but in order to get [LymPro] out for use as quick as possible, we are developing the test so that it can be used as a complementary tool to existing diagnostic tools."
Another reason why the company wants to take it to market quickly, he said, is that the drugs currently used to treat AD are designed for treatment in the early stages of the disease, thus better able to stem its rapid progression. In other words, the earlier patients are diagnosed, the more quickly they can be treated.
About five drugs are available to treat AD, including Aricept from Pfizer (New York).
"Our goal is to improve and enhance the quality of life, extend life so that people are more able to handle their affairs [and] spend more quality time with their loved ones," said Weber.
GW Medical estimates that the global market for LymPro offers the potential for 1 million diagnoses, 25 million early detections and nearly 100 million screening tests annually, with that demand expected to double by 2050.
The company's business model – which takes intellectual property-protected technology and commercializes it for those companies that don't have the capability to do so on their own – means that GW Medical ultimately will "get a piece of the pie," Weber said. That slice typically comes either as a series of licensing fees and/or royalties from the test once it's on the market.
Weber said that the GW Medical is already in discussions with "major players" who could handle product distribution.
Ownership of GW Medical also has established a similar, separate company, Biomarker Technologies (also Phoenix), to commercialize a blood test for breast cancer. That company reported in late March that it would begin a pilot study of the test this month in the U.S.
"We provide the university and/or businesses . . . with royalties," said Weber. "It really depends on what the business requirements are and what their needs are, so each particular business is conducted differently in terms of terms and conditions, but ultimately the model is the same."