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The FDA expressed concern that some laboratory-developed tests may not be as reliable or perform as well as FDA-authorized tests. The pilot program will provide more scrutiny of these tests.
The Elecsys beta-amyloid (1-42) and Elecsys total-tau CSF assays (used as a tTau/Abeta42 ratio) are for use in adults ages 55 and older being evaluated for cognitive issues.
Physiologic responses of therapists as measured by oxytocin levels may play a role in therapeutic outcomes in patients with depression.
High placebo response rates in lupus clinical trials are making it difficult to show treatment effectiveness.
Identification of an antibody linked to spontaneous reversal of cardiac transthyretin amyloidosis may represent a novel approach to treatment of this progressive and fatal condition.