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FDA Clears Tests from Siemens, Quidel, Becton Dickinson, and Roche in February

NEW YORK (360Dx) – Siemens, Quidel, Becton Dickinson, and Roche were among several companies receiving US Food and Drug Administration clearances for tests in February.

Among the test clearances for cancer diagnostics, Roche received clearance at the end of the month for its Elecsys tumor-associated antigen immunological assay. It is intended to aid in the management of breast cancer patients through quantitative determination of CA 153 in human serum and Li-heparin plasma.

For the diagnosis of precancerous polyps and colorectal cancer, the FDA cleared Alfa Scientific Designs' immunoassay fecal occult blood test, which identifies human blood in feces. It uses one drop of sample solution and provides results in as little as one minute, five times quicker than with standard lateral flow assays, Alfa Scientific said.

Quidel had two separate clearances in February. The FDA granted clearance for the firm's Sofia Lyme FIA, which employs immunofluorescence for the rapid differential detection of human IgM and IgG antibodies to Borrelia burgdorferi from serum and plasma specimens from patients suspected of infection. The qualitative test is intended for use as an aid in the diagnosis of Lyme disease, and may be used with the firm's Sofia and Sofia 2 instruments.

Around mid-month, Quidel received clearance for its test to detect and differentiate influenza types A and B. The firm said that the test met FDA criteria to be reclassified as a class II rapid influenza diagnostic test.

Also in the market for flu diagnostics, Mesa Biotech received 510(k) clearance and CLIA waiver for its test to detect and distinguish influenza A and B in nasal swab specimens. The Accula Flu A/Flu B test cassette is the firm's first test to receive FDA clearance, and runs on the firm's Accula Testing System.

Staying within infectious disease diagnostics, DiaSorin received clearance for its Liaison BRAHMS PCT II Gen assay, which uses chemiluminescence technology for the quantitative determination of procalcitonin in human serum and lithium heparin plasma specimens. Used in conjunction with other laboratory findings and clinical assessments, the assay, among other uses, is intended to aid in the risk assessment of critically ill patients on their first day of intensive care unit admission for progression to severe sepsis and septic shock, according to FDA's website.

Vela Diagnostics received clearance for its herpes simplex virus assay. Its Sentosa SA201 HSV-1/2 PCR test detects viral DNA from oral or anal skin lesions in symptomatic patients. Following nucleic acid extraction using the Sentosa SX Virus Total Nucleic Acid Kit, the test runs on 96-well plates on the firm's Sentosa SX101 instrument, with subsequent automated data analysis.

Siemens Healthineers in February announced that it had received 510k clearance for point-of-care tests that measure blood urea nitrogen and total carbon dioxide. The tests run on the firm's handheld Epoc blood analysis system and are intended for use in the diagnosis of kidney diseases and metabolic imbalances. Siemens acquired theEpoc system from Abbott last year as part of its purchase of the Epocal division of Abbott subsidiary Alere.

Becton Dickinson received clearance for the BD Phoenix Automated Microbiology System intended for the quantitative determination of antimicrobial susceptibility. The system uses measurements of minimal inhibitory concentration (MIC) of most gram-negative aerobic and facultative anaerobic bacteria isolates from pure culture for Enterobacteriaceae and non-Enterobacteriaceae, and most gram-positive bacteria isolates from pure culture belonging to the genera Staphylococcus, Enterococcus, and Streptococcus.

In February, the FDA also granted regulatory approvals that were outside its 510(k) clearance pathway.

For example, a molecular test from Becton Dickinson to detect 14 high-risk types of human papilloma virus received premarket approval. The BD Onclarity HPV assay is designed for specimens collected in the BD SurePath liquid-based cytology vial for cervical cancer screening.

Further, the FDA said it has allowed for the first time the marketing of a blood test to evaluate mild traumatic brain injury, commonly known as a concussion. The test from Banyan Biomarkers called the Brain Trauma Indicator measures the levels of the proteins UCH-L1 and GFAP that are released into the blood from the brain within 12 hours of head injury.

And Guardant Health received an expedited access pathway designation for its Guardant360 liquid biopsy assay. The designation will allow the company to work with the FDA to finalize its data development plan as it prepares a regulatory submission later this year, Guardant Health said.