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The FDA said that Terrific Care/Medex Supply distributed certain Roche Diagnostics test strip lots in the US even though domestic sales had been stopped due to safety concerns.
Roche Diagnostics had sales of CHF 12.88 billion in 2018. For the fourth quarter, diagnostics sales totaled CHF 3.5 billion, up 10 percent year over year.
Roche plans to establish a CAP/CLIA-certified protocol for the assay and PhoenixMD will further refine its precision for identifying patients who may benefit from its RSK2 inhibitor.
The issue, discovered in late October, affected TMB reporting for up to 800 FoundationOne CDx tests during a short period of time and was quickly resolved.
A lack of attractive targets, high valuations, and a more attractive IPO market contributed to a 45 percent year-over-year decline in M&A.
The year saw the launch of high-profile platforms as well as efforts by a number of parties to streamline mass spec technologies for the clinic.
The court cited previous US Supreme Court rulings, including Mayo vs. Prometheus, in determining that certain claims of Illumina's patents were invalid.
The immunohistochemistry-based CDx will operate on the Roche BenchMark ULTRA instrument.
By achieving certification for the assay, called PredictSure IBD, the Cambridge, UK-based firm can sell it for clinical use across Europe.
The CDx, which will include the detection of activating FGFR2 fusions, is expected to be incorporated into Foundation Medicine's FDA-approved FoundationOne CDx assay.