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Chugai, a member of the Roche Group, has already filed for regulatory approval of FoundationOne CDx with Japan's Ministry of Health, Labor, and Welfare.
The company plans to grow its business based on the FDA approval and preliminary national coverage determination for its FoundationOne CDx test last year.
The Cobas m 511 combines a cell counter, slide maker and stainer, and a digital morphology analyzer into one integrated solution.
Among companies whose tests were greenlighted by the FDA last month, Quidel received clearances for a test to detect and differentiate influenza types A and B, and for a separate test for Lyme disease.
For full-year 2017, the company reported $152.9 million in revenues, up 31 percent over 2016.
Streck claims that the blood collection tubes in the Roche Ariosa Harmony kit that Cenata uses infringe its patent.
A broad team of researchers has developed a microarray that looks for 171,000 different peptide fragments to differentiate among tick-borne diseases.
Sensitivity problems with rapid antigen tests are also helping the more accurate rapid molecular tests gain wider acceptance, manufacturers said.
Guardant Health said that its Guardant360 liquid biopsy assay has received expedited access pathway designation from the US Food and Drug Administration.
The investment bank gave the company's stock an Outperform rating with a target price of $90 per share.