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FDA Clears AutoGenomics' Thrombophilia Assay as IVD

NEW YORK (GenomeWeb News) — AutoGenomics today said its Infiniti Factor II and Factor V assays and automated instrumentation have received 510(k) clearance from the US Food and Drug Administration.
 
According to AutoGenomics, the assays may help diagnose the bleeding and clotting disorder thrombophilia.
 
The test is an in vitro diagnostic used on blood samples to detect DNA point mutations including Factor II Prothrombin G20210A and Factor V Leiden G1691A, the company said.
 
In December 2006 the company submitted to the FDA an assay for the enzyme CYP450 2C9/VKORC1 to help gauge warfarin dosing.

The Scan

Interfering With Invasive Mussels

The Chicago Tribune reports that researchers are studying whether RNA interference- or CRISPR-based approaches can combat invasive freshwater mussels.

Participation Analysis

A new study finds that women tend to participate less at scientific meetings but that some changes can lead to increased involvement, the Guardian reports.

Right Whales' Decline

A research study plans to use genetic analysis to gain insight into population decline among North American right whales, according to CBC.

Science Papers Tie Rare Mutations to Short Stature, Immunodeficiency; Present Single-Cell Transcriptomics Map

In Science this week: pair of mutations in one gene uncovered in brothers with short stature and immunodeficiency, and more.