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AxonLab will distribute BioGx's entire product line, including laboratory-use-only products, in central European countries.
The US Food and Drug Administration cleared Qiagen's Ipsogen JAK2 RGQ PCR Kit for additional use in the diagnosis of all myeloproliferative neoplasms
An extended labeling claim has added detection of three additional EGFR mutations to help ID NSCLC patients for whom Boehringer Ingelheim's Gilotrif is indicated.
The Singapore-based firm has established a US subsidiary and named distributors to sell its products across Europe, the Middle East, and Asia.
CEO Anders Rylander said the company will initially market its DiviTum assay for breast cancer cases, though it could be used to monitor cell proliferation in all cancer types.
The university is leveraging CDC funding to validate PCR and real-time PCR assays for detecting Candida auris in hospitals.
The PCR-based test, run on Roche's Liat platform, was among several other assays that was cleared by the agency last month.
Through the joint collaboration, Seegene plans to accelerate development of its random access system on Hamilton's automated liquid handling platforms.
Becton Dickinson and Euroclone aim to develop and commercialize the molecular assays for launch outside the US in 2018, and in the US at a later date.
Genomic Health will gain exclusive worldwide rights to develop and sell an IVD version of its Oncotype DX breast cancer test on Biocartis' Idylla platform.