BRNI and Inverness Medical Innovations to develop commercial skin test to detect early Alzheimer's disease

18 June 2009

The Blanchette Rockefeller Neurosciences Institute (BRNI) and Inverness Medical Innovations, Inc. (Inverness, NYSE:IMA) have announced that they will work together to further develop and commercialize a diagnostic test for Alzheimer's disease first discovered by scientists at BRNI.

The BRNI test, once fully commercialized, could dramatically change the time and way that the disease is treated. The agreement also marks the first major global private sector deal involving BRNI technology and science.

Under the terms of the arrangement, Inverness will fund the development efforts to be conducted by BRNI over an initial three year period. Inverness has also obtained an option which, if exercised, will provide Inverness with certain rights to the technology developed for use in the diagnosis, prognosis and monitoring of Alzheimer's disease.

"We are very pleased to be working with the world-class memory institute at BRNI, and share in their commitment to advance this test for Alzheimer's disease," said Ron Zwanziger, CEO of Inverness. "This is an exciting opportunity for Inverness to enhance the lives of patients with chronic disease and continues our commitment to rapidly deploy diagnostics and develop new treatments for devastating diseases such as Alzheimer's."

Affecting over 5 million Americans, Alzheimer's disease (AD) has no recognized cure and is difficult to diagnose. In fact, doctors can only definitely diagnose the illness at autopsy and there is currently no approved biochemical test to diagnose it.

Finding a cure for AD is one of the central missions of the Blanchette Rockefeller Neurosciences Institute. In 2005, the cost to Medicare for care of beneficiaries with AD and other dementias was US$91 billion and the cost to state and federal Medicaid for nursing home care for people with AD and other dementias was US$21 billion.

Dementia currently afflicts over 29 million people worldwide, and the annual global costs of dementia are estimated to amount to US$315 billion.

"It is still challenging to accurately diagnose Alzheimer's disease, but I believe we are on the path to realizing a test that will take the guess work out of proper treatment," said Dr Daniel Alkon, Scientific Director of BRNI. "An accurate early test will allow physicians to treat patients sooner and more effectively before symptoms intensify and the disease rapidly escalates."

The only non-profit independent institution in the world dedicated to the study of human memory and memory disorders, BRNI first discovered the biomarker test's potential in 2006.

By testing for signs of AD-related inflammation in skin cells called fibroblasts, the BRNI team located a biomarker for the disease that can be tested without the invasive procedures previously required, such as a lumbar tap.

The key molecular targets that the BRNI biomarker determines reflect PKC signalling which appears to be compromised very early on during AD and probably well before the onset of clinical symptoms. These pathways could also be a focus for drug therapy.

"An early diagnosis could prevent countless patients from suffering through this devastating disease," said William Singer, President of BRNI's Board of Directors. "This partnership will ensure that expanded clinical trials occur quickly which will be a major leap in bringing a proven Alzheimer's disease diagnostic to the public."

A recent study has been conducted with more than 300 patients in 15 hospitals, and autopsy-confirmations have been obtained from 42 patients. Based on autopsy validation, the BRNI biomarker had a 98% level of accuracy in detecting AD. This accuracy was also achieved for the early diagnosis of AD (within the first four years of memory loss symptoms).

Clinical diagnosis, as confirmed by autopsy, is considerably less accurate in diagnosing AD at such early stages. The BRNI biomarker showed high accuracy when tested with human skin cells from a tissue bank, as well as for samples obtained from the patients with autopsy-confirmed diagnoses.

"Ultimately, the goal of the Blanchette Rockefeller Neuroscience Institute (BRNI) is to cure Alzheimer's disease, and the path to a cure begins with detecting the disease early," said Senator Jay Rockefeller (D-WV), who founded BRNI in honour of his mother. "I applaud the Inverness-BRNI partnership for advancing this research, and I'm deeply proud of the work that goes on every day in West Virginia at BRNI to get us closer to a greater understanding of the disease and a cure."

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