NEW YORK (360Dx) – Hologic, Bio-Rad Laboratories, and Roche were among the companies that received US Food and Drug Administration clearances in June for their in vitro diagnostic tests, according to the FDA website.
The FDA cleared Hologic's Aptima Combo 2 Assay, a nucleic acid test that employs target capture for the detection and differentiation of ribosomal RNA from Chlamydia trachomatis or Neisseria gonorrhoeae and is used with the firm's Panther System to diagnose chlamydial or gonococcal urogenital disease.
Bio-Rad received clearance for its BioPlex 2200 25-OH Vitamin D Kit, a multiplex flow competitive immunoassay used to detect 25-hydroxyvitamin D in serum. The assay is used for assessing vitamin D sufficiency with the firm's BioPlex 2200 System.
Roche received clearance for the Elecsys CA 15-3 II assay for the determination of CA 15-3 in human serum and plasma to aid in the management of breast cancer patients. The electrochemiluminescence immunoassay is used on the Elecsys and Cobas e immunoassay analyzers.
Meantime, Immco Diagnostics received clearance for its ImmuGlo HEp-2 Elite IFA, an indirect immunofluorescence test to detect anti-nuclear antibodies of the IgG isotype in human serum using standard HEp-2 cells and engineered HEp-2 cells as a substrate. The test is used to diagnose systemic rheumatic diseases.
NeuMoDx Molecular received clearance for its NeuMoDx GBS Assay, which detects Group B streptococcus DNA from enrichments of vaginal or rectal swabs from pregnant women. The test incorporates automated DNA extraction to isolate the target nucleic acid from the specimen in addition to real-time PCR.
Ark Diagnostics received clearance for the Ark Fentanyl Assay, an immunoassay used with automated clinical chemistry analyzers to detect fentanyl in human urine at a cutoff concentration of 1.0 2 ng/mL. The assay provides a preliminary analytical test result, but a more specific and alternative chemical method must be used to obtain a confirmed analytical result, the FDA said.
Other companies receiving FDA clearance for their tests last month include Beckman Coulter Diagnostics, which received clearance for the company's high-sensitivity troponin assay. The test received CE marking late last year. Also, Abbott said in June that the FDA cleared its Afinion HbA1c Dx assay to help diagnose diabetes mellitus and assess a patient's risk of developing the disease.
PerkinElmer said in June that it received clearance for its Euroimunn Crithidia luciliae test (CLIFT) and CLIFT sensitive immunofluorescence assays. CLIFT testing supports the detection of anti-double-stranded DNA, one of the markers for the rheumatic autoimmune disease systemic lupus erythematosus.
Fujirebio Diagnostics received clearance for use of its Lumipulse G BRAHMS PCT Assay for testing on the Lumipulse G1200 immunoassay platform. It enables decision-making for patients with suspected or confirmed lower respiratory tract infection, and risk assessment for progression to severe sepsis or septic shock of critically ill patients on their first day of being admitted to the intensive care unit.
DiaSorin Molecular received clearance that extends the sample type claims for its Simplexa HSV 1 & 2 Direct assay, expanding the type of samples that can be tested to genital swabs, and all cutaneous and mucocutaneous swab samples.
The FDA cleared two new blood screening assays developed by Grifols. The Procleix Ultrio Elite is a combined screening test for the HIV-1, hepatitis B, and hepatitis C viruses, and enables detection of HIV-2. It can be used to test pools of plasma composed of up to 96 plasma donor samples. The Procleix WNV test screens serum and plasma donations for West Nile virus. The tests run on Grifols' Procleix Panther system.
Additionally, Sony subsidiary Micronics announced that its PanNAT microfluidic molecular diagnostics system and related test for Shiga toxin-producing Escherichia coli (STEC) received FDA clearance. Lastly, the FDA granted breakthrough device designation for AutoGenomics' Infiniti Neural Response Panel, a genomic test that gauges risk for opioid dependency.