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A study of 10 commercial labs offering NIPT in the US found that none followed all recommendations for reporting results and informing patients and providers.
Symbolized by its first time exhibiting at HIMSS, Roche Diagnostics is using data to bridge the worlds of imaging, sequencing, diagnostics, drug discovery, and treatment.
Roche alleged that lower-priced test strips intended for sale via mail order were redirected for sale at higher prices through retail pharmacies.
The Navify software, which Roche launched today, provides annotation, interpretation, and clinical reporting of next-generation sequencing tests for cancer.
In addition, a German court found in December that German NIPT company Cenata infringes Streck's patent.
The test can now be used to identify triple-negative breast cancer patients who are likely to benefit from the immunotherapy Tecentriq plus chemotherapy.
BioMérieux received clearance for its Vitek 2 gram-negative susceptibility card as a test used to determine the antimicrobial susceptibility of certain aerobic bacilli.
The British molecular diagnostics firm recently completely a redesign of its point-of-care system, called Q-POC, and is planning to seek a CE-IVD mark for the device later this year.
The Polish company recently received 9 million Polish złoty ($2.4 million) from the country's National Center for Research and Development to support its activities.
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.