ArcherDX NGS Assays Receive Conditional Approval by NY State

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.