ArcherDX NGS Assays Receive Conditional Approval by NY State
News Aug 10, 2016
ArcherDX, Inc. has announced that two Archer® FusionPlex® NGS assays have received conditional approval from the New York State Department of Health for clinical use by Memorial Sloan Kettering Cancer Center (MSK). The assays, which are powered by ArcherDX’s proprietary Anchored Multiplex PCR (AMP™) targeted enrichment chemistry, were designed for MSK to identify known and novel gene fusions in blood cancers, sarcomas and solid tumors.
Data generated from validation studies performed by MSK experts has been presented at multiple conferences over the past year. The group reported that Archer assays were reproducible and concordant with results using conventional detection methods such as FISH and RT-PCR. Multiplex analysis also enabled simultaneous detection of different fusions in a single test. The group concluded that Archer assays could improve diagnostic accuracy with less tissue requirements and in a clinically actionable timeframe.
The custom-built RNA fusion assays are beginning to be implemented for routine clinical use alongside the MSK-IMPACT™ panel, a hybrid capture-based targeted DNA sequencing assay. Clinical utilization of AMP-based NGS RNA fusion assays has resulted in improved solid tumor, sarcoma and hematological cancer diagnosis and treatment and patient enrollment into clinical trials for therapies that target actionable gene fusions.
Researchers have created a portable and fast-acting test that can distinguish Ebola infections from other fever-causing infectious diseases such as Lassa fever and malaria in around 30 minutes. Although further testing is required, this could be useful during febrile disease outbreaks.READ MORE