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Luminex, Microgenics, Sentinel Diagnostics, Others Get FDA Clearances in December

NEW YORK – The US Food and Drug Administration cleared in vitro diagnostic tests in December from Luminex, Microgenics, Sentinel Diagnostics, i-Sens, and others, according to the agency's website.

Austin, Texas-based tests and platforms developer Luminex got the nod for its NxTag Respiratory Pathogen Panel, a qualitative test run on the firm's Magpix instrument to simultaneously detect and identify nucleic acids from multiple respiratory viruses and bacteria.

The nucleic acids are measured using nasopharyngeal swabs collected from people with clinical signs and symptoms of a respiratory tract infection, according to a document filed with the FDA. A large number of organism types and subtypes are detected — influenza A, influenza A H1, influenza A H3, influenza B, respiratory syncytial virus A, respiratory syncytial virus B, coronavirus 229E, coronavirus OC43, coronavirus NL63, coronavirus HKU1, human metapneumovirus, rhinovirus/enterovirus, adenovirus, parainfluenza virus 1, parainfluenza virus 2, parainfluenza virus 3, parainfluenza virus 4, human bocavirus, Chlamydophila pneumoniae, and Mycoplasma pneumoniae.

Fremont, California-based Microgenics received clearance for its Cedia Benzodiazepine Assay, a homogeneous enzyme immunoassay to detect benzodiazepines in human urine at a cutoff concentration of 200 ng/mL. A more specific alternative chemical method is needed to obtain a confirmed analytical result, the FDA said. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Tandem Mass Spectrometry (LC-MS/MS) are preferred confirmatory methods.

Milan-based Sentinel Diagnostics got the nod for its Albumin BCP assay to measure albumin in human serum or plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases, primarily those involving the liver or kidneys.

i-Sens, based in Seoul, South Korea, was cleared to market its ReliOn Premier Classic Blood Glucose Monitoring System to measure glucose in fresh capillary whole-blood samples drawn from the fingertips, forearm, palm, thigh, or calf. The system is used for in vitro diagnostic self-testing at home by people with diabetes.

For the collection of capillary blood from the heels of newborn or premature babies, Hong Kong-based Promisemed Hangzhou Meditech received clearance for its Promisemed Heel Blood Lancet.

Meanwhile, the FDA cleared Prague-based Immunotech Vit Oburka's Active Free Testosterone RIA test. The radioimmunoassay is used to measure free testosterone in human serum. Clinicians use free testosterone measurements to diagnose disorders involving male sex hormones, including primary and secondary hypogonadism, delayed or precocious puberty, and impotence. In females, clinicians use free testosterone to diagnose hirsutism, which is growth of excessive hair, and masculinization due to tumors, polycystic ovaries, or adrenogenital syndromes.

In other FDA clearances in December, Holzgerlingen, Germany-based Curetis got the nod for its Unyvero LRT lower respiratory tract application cartridge.

The FDA used its de novo pathway to authorize a new test from Basel, Switzerland-based Roche for the detection of methicillin-resistant Staphylococcus aureus bacterial colonization.

And Roche's Foundation Medicine received approval for its FoundationOne CDx test as a companion diagnostic for alpelisib (Novartis' Piqray) in combination with fulvestrant (AstraZeneca's Faslodex).