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FDA Approves Fred Hutchinson Center Lupus Test

NEW YORK (Reuters Health) Aug 28 - The US Food and Drug Administration

(FDA) has approved a new screening test for lupus developed by the Fred

Hutchinson Cancer Research Center, the Seattle-based non-profit

institution said on Wednesday.

According to the Fred Hutchinson Cancer Research Center, because

symptoms of lupus can range from skin rash and mild fatigue to organ

failure, diagnosis can be difficult. The traditional diagnostic blood

test relies on the detection of autoreactive antibodies, but about

one-fifth of lupus patients do not exhibit such antibodies, and

therefore go undiagnosed.

The newly approved test detects SR proteins, which a spokeswoman for the

Fred Hutchinson Cancer Research Center said are produced by between 50%

and 70% of all lupus patients.

As such, the new test is not a replacement for a traditional blood

screen, she said. But when used in conjunction, the two tests together

are expected to detect about 20% of SLE cases that have previously gone

unidentified.

With the approval, the Fred Hutchinson Cancer Research Center is now

looking for a partner to commercialize the technology, but the

spokeswoman said she is unaware of any actual negotiations that are

ongoing.

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