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Roche COBAS AmpliScreen

This article was originally published in The Gray Sheet

Executive Summary

Automated nucleic acid amplification test (NAT) system gains 510(k) clearance. The laboratory PCR-based system will be used with NAT plasma screening assays for HCV and HIV-1, pending FDA approval. A BLA for the tests was filed earlier this year...

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Roche COBAS AmpliScreen

HIV and HCV nucleic acid amplification test (NAT) screening assays gain biologics license application approval for use with the AmpliScreen system for the blood bank industry. Both plasma screening tests employ the firm's polymerase chain reaction (PCR) technology and are qualitative in vitro tests. The firm announced the AmpliScreen system's 510(k) clearance in December (1"The Gray Sheet" Dec. 9, 2002, In Brief). FDA also grants 510(k) clearance for a data output management/collection system to aid in the gathering of specimen and test data...

A Tale Of Two Pipelines

Immuno-oncology has produced some exciting successes, but the field has become intensely crowded. Enormous resources are being poured into duplicative work and shaky hypotheses—overshadowing other pursuits in cancer research while producing limited results. It is time to re-evaluate how the sector should be pursuing innovation in cancer and how it can be smarter in its use of resources—financial investment, talent, bandwidth, patients and data.

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).




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