ArcherDX NGS assays receive conditional approval by New York State

Published Tue Aug 16, 2016


Boulder, COLORADO – ArcherDX, Inc., the leader in next-generation sequencing (NGS)-based gene fusion detection products, announced today 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.

About ArcherDx

ArcherDX addresses the bottlenecks associated with using NGS in translational research by offering a robust platform for targeted sequencing applications. By combining proprietary Anchored Multiplexed PCR (AMP™) chemistry and easy-to-use, lyophilized reagents, Archer® NGS assays generate highly enriched sequencing libraries to detect gene fusions, point mutations, CNVs and RNA abundance. Complemented by the Archer suite of bioinformatics software, ArcherDX technology dramatically enhances complex mutation identification and discovery.

ArcherDX is headquartered in Boulder, Colorado.

Archer®, FusionPlex®, VariantPlex™ and AMP™ are trademarks of ArcherDX, Inc.

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ArcherDX, Inc.

Jason Amsbaugh
Director of Marketing
jamsbaugh@archerdx.com

+1 303 357 9001

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Boulder, CO 80301

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Phone: (303) 357 9001

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For Research Use Only. Not for use in diagnostic procedures. For Research Use Only. Not for use in diagnostic procedures.