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FDA Clears Tests from Alere, Roche, Cepheid in January

NEW YORK (360Dx) – Abbott's Alere business, along with Roche, Becton Dickinson, and Danaher's Cepheid each received US Food and Drug Administration clearances for tests in January, according to the FDA's website.

Alere, acquired by Abbott in October 2017, received clearances for four tests.

They include the Alere i Influenza A & B, which is a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B in patients presenting with symptoms of respiratory infection. The firm received clearance for Alere i Strep A, a rapid, instrument-based isothermal test for the qualitative detection of Group A Strep from throat swab specimens, and for Alere i RSV, a rapid, instrument-based isothermal test for the qualitative detection and differentiation of respiratory syncytial virus viral RNA in patients with symptoms of respiratory infection.

The FDA cleared Alere i Influenza A & B 2, a rapid, instrument-based isothermal test for the qualitative detection and differentiation of influenza A and influenza B in patients presenting with symptoms of respiratory infection.

Around midmonth, the FDA granted clearance to Roche for its Cobas Factor II and Factor V test, which uses real-time PCR for the detection and genotyping of the Factor II G20210A mutation and the Factor V Leiden G1691A mutation in DNA that's obtained from K2EDTA whole blood specimens. The tests aid in the diagnosis of patients with suspected thrombophilia.

Becton Dickinson received clearance for its Phoenix automated microbiology system for in vitro quantitative determination of antimicrobial susceptibility by minimal inhibitory concentration 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.

The FDA granted clearance for Danaher's Cepheid Xpert Carba-R Assay, an automated real-time PCR diagnostic test for the qualitative detection of several gene sequences from rectal or perirectal swab specimens or isolates of pure cultures of gram-negative bacteria that are not susceptible to carbapenem. The assay is intended as an aid for infection control and for monitoring the spread of organisms that are not susceptible to carbapenem in healthcare settings.

Additionally, Cepheid received 510(k) clearance and CLIA waiver from the FDA for a new test system and influenza molecular diagnostic test.

The test, called Xpert Xpress Flu, can be used in near-patient settings to detect both A and B strains of influenza from either nasopharyngeal or nasal swabs. It targets multiple regions within the RNA-based influenza genomes to increase sensitivity and guard against antigenic drift.

Other companies that received FDA clearance for their tests or testing systems in January include Meso Scale Diagnostic, which received clearance for its conventional C-reactive protein assay, which is based on the company's Multi-Array technology.

Qiagen received clearance for its Ipsogen JAK2 RGQ PCR Kit for additional use in the diagnosis of all myeloproliferative neoplasms.

In March 2017, the FDA had cleared the assay as a qualitative in vitro diagnostics test for the detection of the JAK2 V617F/G1849T allele in genomic DNA extracted from EDTA whole blood to aid in the diagnosis of the blood cancer polycythemia vera.

Qiagen also received clearance for extended indications for use of its Therascreen EGFR RGQ PCR kit to guide the use of Boehringer Ingelheim's Gilotrif (afatanib) for first-line treatment of patients with metastatic non-small cell lung cancer harboring non-resistant EGFR mutations.

Specifically, FDA approved a premarket authorization supplement extending the labeling claim of the Therascreen kit to include detection of EGFR mutations L681Q, G719X, and S7681 to help identify NSCLC patients for whom Gilotrif is indicated.

Sebia received clearance for its Hydrashift 2/4 daratumumab assay for evaluating multiple myeloma patients treated with Darzalex (daratumumab).

The assay was developed in collaboration with Janssen Biotech, which jointly developed Darzalex with Genmab. Sebia is the worldwide supplier of the assay, which received CE mark in November 2016, and runs on the Sebia Hydrasys 2 agarose gel platform. 

The FDA granted premarket approval for Hologic's Aptima HBV Quant Assay for quantitation of hepatitis B viral load on its fully automated Panther system.

The assay reliably quantitates HBV DNA across genotypes A-H, provides a dual-target approach that delivers accurate quantitation over a broad linear range, and tolerates potential mutations in the HBV genome, Hologic said.

Techlab received 510(k) clearance for two tests intended to aid in the diagnosis of campylobacteriosis, which is produced by Campylobacter, a foodborne pathogen that's among the most common causes of diarrheal illness in the US.

The FDA cleared Bio-Rad Laboratories' IH-Incubator L and IH-Centrifuge L instruments for use with the company's full range of IH-System Gel Reagents for manual blood typing.

Diazyme Laboratories received 510(k) clearance for its fully automated two-reagent EZ Vitamin D assay for use on validated clinical chemistry analyzers.

The FDA expanded the indication for AstraZeneca's PARP inhibitor Lynparza (olaparib) for metastatic breast cancer patients who have BRCA-mutated tumors.

Simultaneously, the agency also expanded the indication for Myriad Genetics' BRACAnalysis CDx as a test that can identify which breast cancer patients have germline BRCA mutations and therefore are most likely to benefit from Lynparza.

And Inova Diagnostics received clearance for its Quanta Flash Calprotectin assay for the detection of fecal calprotectin in human stool samples.