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FDA Clears Assays from Thermo Fisher, Roche, and CDC


NEW YORK (360Dx) – Thermo Fisher Scientific received 510(k) clearance from the US Food and Drug Administration last month for its assay for assessing patients suspected of having sepsis, one of a number of diagnostic tests that the agency cleared for marketing in June.

Thermo Fisher's Architect BRAHMS PCT assay is a chemiluminescent microparticle immunoassay for the quantitative determination of procalcitonin in human serum and plasma on the company's Architect system, according to an FDA document. In conjunction with other laboratory findings and clinical assessments, the assay is for use in assessing the risk of critically ill patients on their first day in the ICU for the progression of severe sepsis and septic shock; assessing the cumulative 28-day risk of all-cause mortality for patients diagnosed with sepsis or septic shock in the ICU; as an aid in determining antibiotic use for patients with suspected or confirmed lower respiratory tract infections in an inpatient setting or emergency department; and as an aid in deciding when to end antibiotic therapy for patients with suspected or confirmed sepsis.

The assay, which is CE marked, was codeveloped by Thermo Fisher and Samsung Electronics.

Also in June, the FDA cleared Roche Diagnostics' Elecys Toxo IgM immunoassay for the in vitro qualitative detection of IgM antibodies to Toxoplasma gondii in human serum and plasma. The test is for use in helping diagnose an acute or recent Toxoplasmosis infection in suspected patients and pregnant women, the FDA said. Testing should be done in conjunction with an anti-Toxoplasma gondii IgG antibody assay.

Additionally, the FDA gave 510(k) clearance to the US Centers for Disease Control and Prevention to market its Rickettsia real-time PCR assay. The test is for the qualitative detection and differentiation of R. rickettsii and R. prowazekii DNA extracted from venous whole blood preserved with ethylenediaminetetraacetic acid or acid citrate dextrose Solution A.

The assay is intended for use with specimens from individuals suspected of having Rocky Mountain spotted fever, epidemic typhus, or other rickettsial infections and epidemiological risk factors consistent with potential exposure. Presumptive positive results from the assay need to be confirmed by the CDC.