Innogenetics testing shows advances for diagnosing early-stage Alzheimer's disease

By Elaine Rigoli

Tampa, Fla., Feb. 21 - Innogenetics said Tuesday that its Alzheimer's disease tests may predict progression to Alzheimer's disease in patients presenting with early-stage memory impairment.

The results were obtained independently by European and Japanese clinical teams who carried out large prospective studies that were recently published in major medical journals.

In each case, the commercially available Innogenetics test panel showed evidence of Alzheimer's disease long before clinical symptoms appeared.

Among the key studies was a large prospective trial at Lund University, Sweden involving 137 patients with mild cognitive impairment who were at possible risk to develop Alzheimer's, and 39 healthy controls.

After a four- to six-year follow-up, the relative risk was substantially greater in those patients who showed abnormal concentrations of the biomarker proteins tau, beta-amyloid, and phospho-tau in cerebrospinal fluid, according to a company news release.

The combination of tau and the ratio of beta-amyloid/phospho-tau yielded results (sensitivity 95%, specificity 87%) considerably higher than those achievable through a clinical examination alone.

This research study was carried out with the new Inno-Bia AlzBio3 multiparameter testing panel developed by Innogenetics, the release stated.

Similarly, a just-published Italian study using the same biomarkers investigated the clinical evolution of 180 patients presenting at the University of Perugia with memory complaints who were followed for 30 months.

Diagnostic assessment showed that pathological levels of cerebrospinal fluid biomarkers detected by Innogenetics' Innotest assays could not only predict the evolution of memory impairment to Alzheimer's disease, but also correctly identify those persons who would not go on to develop dementia, according to the release.

Each of these studies showed that the combined use of these biomarkers can correctly predict which patients presenting with mild memory disturbances will convert to Alzheimer's disease. This explains why, according to a recent article in the journal Nature Medicine, European clinicians favor the testing of CSF biomarkers for early Alzheimer's disease diagnosis, the statement said.

"Innogenetics has clearly become the world leader in neurodegeneration assays. Based on the results now achieved in Europe and Japan with its gold-standard biomarkers, clinicians can use the company's panel of tests with increasing confidence to predict AD [Alzheimer's disease] up to five years before clinical symptoms appear," said Frank Morich, Innogenetics chief executive officer, in a statement.

Innogenetics is an international biopharmaceutical company building parallel businesses in the areas of specialty diagnostics and therapeutic vaccines. Its headquarters is in Gent, Belgium, with sales affiliates in the United States, Germany, France, Spain, Brazil and Italy.

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