DiaGenic ASA (DIAG), a Norwegian in-vitro diagnostics company, dropped the most on record in Oslo after saying that its MCItect test for early stage Alzheimer’s Disease unexpectedly failed to meet the objectives of a patient study.
“Final study results are still in progress, but it is clear that the current version of MCItect has not demonstrated the diagnostic accuracy we deem is required for CE-marking, U.S. studies and commercialization,” Chief Executive Officer Paul de Potocki said in a statement today. “A back-up program for a modified version of MCItect has been prepared and may be quickly initiated.”
DiaGenic, based in Oslo, slumped as much as 54 percent, the most since the shares went on the market in August 2004. The stock traded 40 percent lower at 0.43 krone as of 10:10 a.m., making it the biggest decliner on the Oslo stock exchange’s All-Share index today. About 13 times the three-month average daily volume of shares traded.
“Today’s news was very unexpected because DiaGenic has had good enough results a year ago from a couple of previous studies with MCItect,” Norne Securities analyst Jonas Peciulis said in an e-mailed response to questions. “CE-marking of this test was expected by the end of this year followed by subsequent marketing in Europe and progress with the clinical trials in the U.S. for filing with the FDA.”
DiaGenic has developed gene-expression technology that uses blood samples to help researchers find patterns, or unique genetic fingerprints, which characterize a specific disease. The method is intended to help detect illnesses including breast cancer and Alzheimer’s, the sixth-largest cause of death in the U.S., according to the Alzheimer’s Association.
While DiaGenic may begin a program with a modified version of its MCItect test, “even if this happens, a lot of time and more new capital will be needed,” Peciulis said. “This leaves DiaGenic with one remaining important trigger this year,” a study of its AMYtect test with GE Healthcare’s Alzheimer’s disease imaging tracer, flutemetamol, the analyst wrote.
Norne doesn’t have a price estimate or recommendation on DiaGenic, Peciulis said.
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