FDA Approves Fred Hutchinson Center Lupus Test

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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.