Put It on the Board, 5/17

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FDA clears Roche Cobas e 801 immunoassay module

Roche’s dedicated high-volume testing immunoassay solution for the Cobas 8000 modular analyzer series, the Cobas e 801 module, has received 510(k) clearance from the Food and Drug Administration.

Roche says its new module is designed for maximum consolidation at a high throughput and reduces generated waste. It almost doubles the currently available immunoassay testing capacity on the same footprint, Roche says, delivering up to 300 tests per hour and providing 48 reagent channels. It is designed to use at least 25 percent less patient sample than its predecessor.

Up to four Cobas e 801 modules can be configured in a series, delivering up to 1,200 tests per hour across up to 192 reagent positions. The module allows for continuous, on-the-fly loading of reagents and consumables.
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DiaSorin granted EUA for fully automated Zika IgM test

DiaSorin received FDA emergency use authorization for the Liaison XL Zika Capture IgM assay, a fully automated serology assay for the detection of Zika virus infection.

“Using the proven Liaison XL platform along with an innovative assay format, utilizing the Zika NS1 antigen, DiaSorin was able to produce an assay that yields results in as little as 37 minutes after the specimen is placed on the platform,” John Walter, DiaSorin president, said in a statement.

Specimens used with the Liaison XL Zika Capture IgM assay should be collected between eight days and 10 weeks after onset of symptoms or risk of exposure.
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Advia Centaur XPT has comprehensive ID menu

Siemens Healthineers’ newest addition to the Advia Centaur portfolio, the XPT Immunoassay System, now offers a comprehensive infectious disease testing menu. The system can process up to 240 tests per hour and offers laboratories a portfolio of more than 70 assays.

It has assay features such as “Hot Zone” integration (for the HBsAg I I assay) to reduce the need for additional testing and system software features such as the Smart algorithm to automate reflex testing.
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Roche CINtec Histology test receives FDA clearance

Roche received 510(k) clearance from the FDA for the CINtec Histology test. It is a clinically validated p16 biomarker test that, when used in conjunction with H&E staining, helps pathologists determine which women should receive treatment for cervical pre-cancer. This test is a part of the Roche cervical cancer portfolio, which includes the Cobas HPV test and the CINtec Plus Cytology test. FDA clearance was based on the results generated in the CERTAIN (Cervical Tissue Adjunctive Analysis) study.
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