NEW YORK (360Dx) – TearLab will pursue initial US Food and Drug Administration clearance of a test card measuring a single inflammatory biomarker, MMP-9, in combination with the firm’s FDA-cleared osmolarity test, instead of two biomarkers plus osmolarity, as originally planned. The timing of the filing for FDA clearance is not expected to change, TearLab said, adding it still anticipates filing its FDA submission by the end of 2017. TearLab CEO Seph Jensen said that seeking clearance of one biomarker in combination with the firm’s osmolarity test will expedite the regulatory process and provide greater clarity on reimbursement expectations.
The European Commission cleared Becton Dickinson’s planned acquisition of C. R. Bard, contingent on BD divesting its soft tissue core needle biopsy product line. BD had purchased the business when it bought CareFuson. BD announced in April it would acquire C. R. Bard for $24 billion. The company reiterated that the deal is expected to close in the current quarter.
WuXi NextCode has brought Oxford Nanopore Technologies' sequencing technology into its Shanghai Laboratory, making it initially available to customers in China. The company's Shanghai laboratory, which is CLIA-certified and CAP-accredited, already has a number of sequencing instruments available, including platforms from Illumina, Thermo Fisher Scientific, and Pacific Biosciences.
Oxford Nanopore's technology seemed like a good complement to these, owing to its small size and the comparatively low cost of the instrument, and the company had requests from its customers for offering the platform, WuXi NextCode CEO Hannes Smarason said. "It opens up different types of applications, and this is why we thought it was at the point to integrate it into this open-access platform for genomic data that we're creating," he added.
Both the Oxford Nanopore MinIon and the higher-throughput PromethIon have been installed at WuXi NextCode's lab, he said, and the company is ready to accept customer samples.
Smarason said the Oxford Nanopore technology will be especially well suited for projects that require a rapid turnaround time and long reads that can more easily deal with repetitive and other difficult-to-sequence regions.
Biocept launched its molecular pathology partnership initiative to enable community pathologists to review biomarkers found in liquid biopsy results from patients diagnosed with cancer. Patient specimens will be sent to the firm’s CLIA-certified, CAP-accredited lab.
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