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Cobas HPV test approved for first-line screening using SurePath preservative fluid

August 2018—Roche received FDA approval for the Cobas HPV test to be used as the first-line screening test for cervical cancer in women 25 and older using specimens collected in SurePath preservative fluid.

The Roche test is now the only HPV test approved for use as a primary screening test with both SurePath and ThinPrep PreservCyt Solution. It is approved for all of the screening indications supported by guidelines—primary screening in women 25 and older, reflex testing of unclear Pap test results in women 21 and older, and cotesting with a Pap test in women 30 and older—with both of the primary collection media types.

“With this additional approval for the Cobas HPV Test, laboratories and clinicians now have an approved option that can be used for all of their HPV screening indications and sample types,” Ann Costello, head of Roche tissue diagnostics, said in a statement.

Beckman, Arkray announce iQ Workcell launch

Beckman Coulter and U.S. Arkray announced a new partnership and the launch of the iQ Urinalysis Workcell.

The iQ Workcell pairs the Beckman Coulter Iris iQ200 Digital Flow Morphology system and the Arkray Aution Max AX-4030 fully automated urine analyzer. This total urinalysis offering is available in the U.S. exclusively through Beckman Coulter, which also offers the Arkray Aution Max AX-4030 and the Arkray Aution Eleven AE-4022 analyzers as standalone solutions.

“Through this partnership with Beckman Coulter, Arkray can respond to the market demand to pair Aution chemistry with sediment solutions. This combination of a fully automated urinalysis solution combined with a back-up solution and standardized test strips deliver continuity within laboratory networks,” Shane Hawes, Arkray general manager, said in a statement.

The new iQ Workcell will be offered in three configurations: iQ 3000, 2000, and 1500 Workcells.

FDA grants breakthrough device designation for Elecsys CSF assays

The FDA has granted breakthrough device designation to Roche’s Elecsys β-Amyloid (1–42) CSF and Elecsys Phospho-Tau (181P) CSF. These immunoassays are for the measurement of the β-amyloid (1–42) and phospho-tau concentrations in cerebrospinal fluid in patients with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of dementia.