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Roche, Siemens, Hologic, and Others Receive FDA Clearances in April

NEW YORK (360Dx) – Roche, Siemens, Hologic, and Qiagen were among several companies that received US Food and Drug Administration clearances for technologies in April, according to the FDA website.

In the second week of April, Siemens Healthineers received 510(k) clearance for its Atellica IM Folate Assay for the quantitative detection of folate in serum or red blood cells using the Atellica IM Analyzer. Clinicians use folic acid measurements in the diagnosis and treatment of anemias.

Later in the month, the FDA cleared the Sysmex UF-5000 Fully Automated Urine Particle Analyzer for use by clinical laboratories in the analysis of red blood cells, white blood cells, epithelial cells, cast, and bacteria. The urine particle analyzer also flags the presence of pathologic cast, crystals, sperm, yeast-like cells, and mucus, according to the FDA.

Roche received several clearances. The FDA cleared a modification to its previously-cleared CoaguChek XS Plus System, which is used to monitor blood-clotting values with the firm's CoaguChek XS PT test strips. The agency similarly cleared a modification to Roche's previously cleared CoaguChek XS Pro system, consisting of the CoaguChek XS Prometer and CoaguChek XS PT Test strips, which is used to quantitatively determine prothrombin time using capillary blood or whole blood from a vein.

Also in April, Roche announced that it had received premarket approval for expanded use of its Cobas EGFR Mutation Test v2 as a companion diagnostic test with AstraZeneca's Tagrisso (osimertinib) for non-small cell lung cancer patients. It received 510(k) clearance for its Cobas CT/NG assay for use on its Cobas 6800 and 8800 systems to directly detect the DNA of Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) in symptomatic and asymptomatic individuals.

The FDA cleared Hologic's Eviva Stereotactic Guided Breast Biopsy System to enable providing breast tissue samples for diagnostic breast abnormalities under stereotactic breast biopsy guidance. The Eviva device is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

Hologic also received premarket approval for its ThinPrep Integrated Imager, which the firm said will allow automated imaging tests to become more widely available to laboratories and cytologists in the US.

The FDA cleared the Infrared Laboratory Systems Synermed Enzyme Immunoassay intended for the qualitative and semi-quantitative detection of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with several automated clinical chemistry analyzers.

Also for drug testing, the FDA cleared Assure Tech's Panel Dip Tests and Quick Cup Tests, which are competitive binding, lateral flow immunochromatographic assays, for the qualitative and simultaneous detection in human urine of amphetamine, oxazepam, cocaine, marijuana methamphetamine, morphine, oxycodone, secobarbital, buprenorphine, methylenedioxy-methamphetamine, phencyclidine, methadone, EDDP, nortriptyline and d-Propoxyphene.

Foundation Medicine received FDA Breakthrough Device designation for a new liquid biopsy assay it is developing and which is an expanded version of its existing FoundationACT assay.

Bruker received clearance for its MALDI Biotyper system for the detection of Candida auris.

The FDA approved Qiagen's test for assessing the risk of spontaneous preterm birth in patients with preterm labor symptoms.

EKF Diagnostics received 510(k) clearance and a CLIA waiver for use of its hand-held reagent-free hemoglobin analyzer, the DiaSpect Tm, in point-of-care settings.

And DiaSorin received FDA clearance to market the Liaison BRAHMS PCT II Gen assay for the quantitative determination of procalcitonin in the US.