The Race for Diagnostic Tests for Alzheimer's

General Electric (GE), Bayer, and Avid Radiopharmaceuticals are racing to give doctors a tool they've sought for 100 years: an early test for Alzheimer's. A quick, definitive diagnosis would enable patients to start drug treatments earlier, participate in clinical trials for experimental medicines, and plan for their futures. If a test came back negative, the doctor would be able to look for other causes of memory lapses, such as small strokes.

The companies are developing dyes to identify clumps of brain proteins called beta amyloid that are markers for Alzheimer's. Avid, a Philadelphia startup, completed the final stage of testing needed for U.S. approval and aims to submit an application to the Food & Drug Administration before yearend. That may give it a year's head start before products arrive from GE and Bayer. The three companies presented their data at the International Conference on Alzheimer's in Honolulu that ran from July 10-15. As many as 5.1 million Americans may suffer from the disease, according to the National Institutes of Health. Worldwide, the market for the new diagnostic dyes could be worth $3 billion a year, estimates Cambridge (Mass.)-based consultants Scientia Advisors.

The dyes are designed to cause beta amyloid concentrations to light up when patients' brains are scanned using PET, or positron emission tomography. Currently the tell-tale proteins can be seen only in an autopsy. To spot the disease closer to its onset, doctors must rely on memory tests, family history, and interviews with relatives. While there is no cure, drugs such as Aricept, from Pfizer (PFE) and Eisai, can ease the symptoms and may be especially helpful if administered at an early stage. Once the new imaging agents are available, the Alzheimer's market could swell to $10 billion, according to Scientia.

Avid's early lead doesn't guarantee success. Marketing prowess also counts, as does the accuracy of the brain scans produced with the aid of the dyes. "When you're running a marathon, it's hard to come from behind unless you're superior," says Scientia managing partner Harry Glorikian.

Jonathan Allis, global head of imaging for GE Healthcare, contends that only his company has the combination of hardware, software, and "wetware" (for nonscience geeks, that's biology) to prevail. "Amyloid imaging alone is not enough," he says. Diagnosis and treatment should also involve behavioral assessments and monitoring for abnormal proteins in the blood. Then there's "the need for powerful software analysis to help clinicians make sense of it all," says Allis.

German drugmaker Bayer has no presence in the medical equipment market. But it has had a stake in diagnostics since the 1930s, and imaging agents are a natural outgrowth of that business, says Barbara Putz, Bayer's head of clinical development for molecular imaging.

To make up for its small size, Avid may opt to take on a partner to help sell its Alzheimer's test. One candidate could be Siemens (SI). In addition to making the dye for Avid, the German company sells a range of medical imaging equipment, including PET scanners. Avid Chief Executive Officer Daniel M. Skovronsky declined to comment on the future of the relationship with Siemens other than to say that startups like Avid have a need for strong partners and backers. "We are always thinking about where our next dollar is going to come from," says Skovronsky.

One of the tests' biggest contributions may be to spur development of new treatments for Alzheimer's. P. Murali Doraiswamy, who heads the biological psychiatry division of Duke University's Institute for Brain Sciences and has been involved in Avid's drug trials, believes the dyes will give researchers a real window into the disease. Says Murali: "You can pick out patients who have higher levels of amyloid, expose them to treatments, and see if the treatment is clearing out the amyloid in the brain or not."

The bottom line: The race is on to create a diagnostic test for Alzheimer's disease. The prize is profits and better patient care.

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