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July 15, 2005
FDA Raises Questions About Alzheimer's Test Kit
"MAYWOOD - Nymox Pharmaceutical Corp.'s application for clearance of its AlzheimAlert urine test kit to help doctors diagnose Alzheimer's disease doesn't provide sufficient proof the product works, U.S. regulators said Thursday. "It is unclear if this device is effective at meeting the stated indications for use," based on existing studies, Food and Drug Administration scientists wrote in a staff review posted on the agency's Web site. The company's shares fell 9.1 percent, their biggest one-day percentage drop in almost a year. The FDA had rejected a previous application for the same doctor-kit form of the test, which now must be processed by Nymox as a laboratory service.
Nymox, which develops drugs and tests for aging-related diseases, will seek to persuade a panel of FDA advisers today in Gaithersburg, Md., to support sales of the kits for doctors to use along with other diagnostic methods.
The urine test measures the presence of a brain protein that is elevated in patients with Alzheimer's, a disease that afflicts as many as 4 million Americans, according to the National Institute on Aging. Shares of Nymox which is based in Maywood and in St. Laurent, Canada, fell 22 cents to close at $2.20 in Nasdaq composite trading, the biggest one-day percentage drop since Aug. 11. The shares have dropped 40 percent in the past 12 months.
AlzheimAlert is certified in the U.S. as a laboratory testing service, and a kit version is available in Europe, Nymox said in a July 8 statement. The test measures the protein as a surrogate marker for the likelihood of the disease. No definitive diagnostic test exists for Alzheimer's, the most common form of dementia, according to the National Institute on Aging.
The telltale plaques and tangles the disease causes in the brain can be conclusively identified only by examining the tissue after death. Clinical diagnoses are limited to "possible" or "probable" cases, according to the institute.
A phone call to Chief Financial Officer Roy Wolvin on Thursday wasn't immediately returned."
Source: Geraldine Ryerson-Cruz. FDA raises questions about Alzheimer's test kit. Bloomberg News (15 July 2005) [FullText]
Nymox, which develops drugs and tests for aging-related diseases, will seek to persuade a panel of FDA advisers today in Gaithersburg, Md., to support sales of the kits for doctors to use along with other diagnostic methods.
The urine test measures the presence of a brain protein that is elevated in patients with Alzheimer's, a disease that afflicts as many as 4 million Americans, according to the National Institute on Aging. Shares of Nymox which is based in Maywood and in St. Laurent, Canada, fell 22 cents to close at $2.20 in Nasdaq composite trading, the biggest one-day percentage drop since Aug. 11. The shares have dropped 40 percent in the past 12 months.
AlzheimAlert is certified in the U.S. as a laboratory testing service, and a kit version is available in Europe, Nymox said in a July 8 statement. The test measures the protein as a surrogate marker for the likelihood of the disease. No definitive diagnostic test exists for Alzheimer's, the most common form of dementia, according to the National Institute on Aging.
The telltale plaques and tangles the disease causes in the brain can be conclusively identified only by examining the tissue after death. Clinical diagnoses are limited to "possible" or "probable" cases, according to the institute.
A phone call to Chief Financial Officer Roy Wolvin on Thursday wasn't immediately returned."
Source: Geraldine Ryerson-Cruz. FDA raises questions about Alzheimer's test kit. Bloomberg News (15 July 2005) [FullText]
posted by Dr. Koudinov @ 15.7.05
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