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Alere received clearance for the Afinion HbA1c Dx and for the Alere i Strep A 2, a rapid molecular test for the qualitative detection of Streptococcus pyogenes.
Five Prime will use an IHC CDx to analyze the use of investigational drug candidates in patients with advanced gastric or gastroesophageal junction cancer.
Roche is developing an immunohistochemnistry assay for Pierre Fabre's oncology drug candidate, an antibody drug conjugate targeting insulin-like growth factor 1 receptor.
The claim, enabling streamlined screening of pooled samples, follows updated industry recommendations for Zika virus screening in the US blood supply.
Roche received several clearances, including for its Cobas CT/NG assay and for modifications to previously cleared blood clotting systems.
Despite the astronomical costs, it may prove challenging to reverse course and discontinue Zika testing according to a commentary article accompanying a NEJM study.
The companies will work together to enable Foundation Medicine’s assays to be offered across Dian’s network of laboratories in China.
Lifted by a strong flu season, Cobas Liat PCR placements reached 1,500 systems in the US. Globally, year-over-year sales for the point-of-care system grew 262 percent.
Digital pathology has been relegated to research use only in many smaller labs, but an FDA approval last year, and more options targeted to them, may change that.
The company unveiled forthcoming products for high-throughput molecular testing, diagnostic lab informatics, and microbiology automation.