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Dx Focus: BD Diagnostics; Idera and Abbott; Curetis; Epistem; DaVita Kidney Care and Roche

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BD Diagnostics, a segment of Becton Dickinson, this week announced the availability of the US Food and Drug Administration-cleared BD MAX Enteric Bacterial Panel for use on the BD MAX system.

The BD MAX Enteric Panel is a qualitative in vitro diagnostic test that detects DNA from Campylobacter spp. (jejuni and coli), Salmonella spp., Shigella spp./enteroinvasive Escherichia coli, as well as stx 1 and stx 2 genes in stool specimens.

These pathogens are responsible for up to 95 percent of bacterial gastroenteritis and account for millions of deaths annually, according to the US Centers for Disease Control and Prevention.

The new panel is designed to detect bacterial pathogens in line with widely recommended clinical testing algorithms that use patient history and clinical presentation to select diagnostic tests, BD said. The use of focused panels enables the implementation of enteric molecular testing in a cost-effective manner.

Additionally, the BD MAX Enteric Bacterial Panel allows laboratories to implement CDC-recommended and Joint Commission-required STEC screening. Specimen types include unpreserved and Cary-Blair preserved stool specimens from symptomatic patients with suspected acute gastroenteritis, enteritis, or colitis.

"The BD MAX Enteric Bacterial Panel is the first FDA-cleared assay in the BD MAX Enteric portfolio and we plan to add additional panels that include viral, parasite, and extended bacterial detection," Doug White, vice president and general manager of molecular diagnostics and women's health at BD Diagnostics, said in a statement.

The assay was CE marked in March 2013 for the qualitative detection of the parasitic enteric pathogens Giardia lamblia, Cryptosporidium spp. (hominis and parvum), and Entamoeba histolytica directly from stool specimens.


Idera Pharmaceuticals said this week that it has entered into an agreement with Abbott to develop an in vitro companion diagnostic test for use in Idera's clinical development programs to treat certain genetically defined forms of B-cell lymphoma with its lead drug candidate IMO-8400.

Under the agreement, Abbott will develop a test using PCR technology to identify the presence of the MYD88 L265P oncogenic mutation in tumor biopsy samples with high sensitivity and specificity. This mutation can be identified in approximately 90 percent of patients with Waldenström's macroglobulinemia and about 30 percent of patients with the ABC subtype of diffuse large B-cell lymphoma, Idera said. The mutation plays a key role in activating the Toll-like receptor pathways targeted by IMO-8400.

Financial terms of the agreement were not disclosed.


Curetis said this week that it has launched its Unyvero i60 Implant and Tissue Infection (ITI) cartridge in Europe.

The new cartridge runs on the Unyvero molecular testing system and was developed to rapidly identify more than 90 pathogens and more than 20 resistance markers common in eight clinical indications. Commercial launch and roll-out has already begun in close collaboration with Heraeus Medical, Curetis' development and commercialization partner for the Unyvero i60 cartridge. The company has already placed cartridges at major clinical centers in Germany, Austria, and Switzerland.

Curetis, based in Holzgerlingen, Germany, said that its new cartridge received CE IVD marking following the successful completion of a performance evaluation study involving more than 750 cartridges. Analytical sensitivity testing was conducted in 350 cartridges, while more than 400 cartridges were run with patient samples. Samples of various clinical indications were obtained for the trial, including periprosthetic joint infections, diabetic foot, catheters, surgical sites, skin and soft tissue, and cardiology-related infections; and the Unyvero system analyzed challenging native clinical sample types such as swabs, synovial fluid, sonication fluid, tissue, and catheters, Curetis said.

The i60 cartridge detected several key pathogens with sensitivities of between 75 percent and 100 percent at an overall panel sensitivity of 67 percent and panel specificity of 97.8 percent for the 81 analytes that have been successfully validated so far. The i60 cartridge also identified 147 clinically important pathogens not found by standard microbiology culture, the company said.


Epistem recently demonstrated the Genedrive IL28B genotype assay, the first of a panel of hepatitis C tests for its Genedrive platform, a handheld point-of-care molecular diagnostic device.

Epistem demonstrated the test at the European Association for the Study of Liver meeting held last month in London. A SNP in the IL28B (interleukin-28B) gene predicts response to HCV treatment with interferon. From buccal swabs provided by conference delegates, Epistem demonstrated successful IL28B genotype results in less than an hour using the Genedrive device.

Manchester, UK-based Epistem is developing Genedrive for diagnostic and genotype testing across a range of areas including bacterial, viral, and fungal identification as well as germline and somatic genotype analysis.

Genedrive IL28B is the first of a panel of HCV tests that Epistem is developing alongside the European Commission's 7th Framework Programme for the development of point-of-care HCV tests that will aid in selection of patients who will respond to treatment with pegylated-interferon and/or ribavirin therapy. Epistem is also developing diagnostic and viral load tests to aid patient clinical and therapy management. The IL28b test will be made available as a research-use-only product over the coming months followed by subsequent CE-IVD regulatory approval, the company said.


DaVita Kidney Care, a division of Deland, Fla.-based DaVita HealthCare Partners, said that its DaVita Labs diagnostic dialysis laboratory has implemented hepatitis C molecular diagnostic testing using qPCR testing technology from Roche Diagnostics.

Specifically, DaVita Labs will be the first dialysis laboratory in the country to test for HCV viral load using the Cobas Ampliprep/Cobas TaqMan HCV v.2 test from Roche. This DNA-based technology will enable DaVita Kidney Care to help nephrologists manage patients with chronic HCV in conjunction with clinical and laboratory markers of infection, the organization said. The test can be used to predict the probability of sustained virologic response early in the course of antiviral therapy and to assess a patient's response to antiviral treatment.

"The Roche technology provides state-of-the-art capabilities that will allow our physicians to more rapidly monitor the status of HCV infection, and, in keeping with the latest Centers for Disease Control recommendations, determine the level of viremia," Jason Cline, vice president and general manager of DaVita Labs, said in a statement.

DaVita Labs will also evaluate viral load tests for hepatitis B, HIV, and cytomegalovirus – all of which are cleared by the US Food and Drug Administration – on the Roche Cobas platform.

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