Skip to main content
Premium Trial:

Request an Annual Quote

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

Genome Sequences Reveal Range Mutations in Induced Pluripotent Stem Cells

Researchers in Nature Genetics detect somatic mutation variation across iPSCs generated from blood or skin fibroblast cell sources, along with selection for BCOR gene mutations.

Researchers Reprogram Plant Roots With Synthetic Genetic Circuit Strategy

Root gene expression was altered with the help of genetic circuits built around a series of synthetic transcriptional regulators in the Nicotiana benthamiana plant in a Science paper.

Infectious Disease Tracking Study Compares Genome Sequencing Approaches

Researchers in BMC Genomics see advantages for capture-based Illumina sequencing and amplicon-based sequencing on the Nanopore instrument, depending on the situation or samples available.

LINE-1 Linked to Premature Aging Conditions

Researchers report in Science Translational Medicine that the accumulation of LINE-1 RNA contributes to premature aging conditions and that symptoms can be improved by targeting them.