Powered by anchored multiplex PCR chemistry, the in vitro diagnostic offerings target fusion and variant detection for molecular pathology laboratories.
Integrated DNA Technologies (IDT) has launched its first in vitro diagnostic (IVD) products, marking the company’s entry into the next-generation sequencing (NGS) clinical market. The company announced the availability of Archer FUSIONPlex-HT Dx and VARIANTPlex-HT Dx in the US and select European countries, targeting molecular pathology laboratories that require standardized, regulatory-compliant workflows in oncology diagnostics.
The launch represents the first of multiple planned IVD product releases on IDT’s NGS roadmap, with the company citing growing demand among clinical labs for solutions that offer a clear, validated path from research discovery to diagnostic application.
“At IDT, we believe that precision diagnostics should be as reliable as they are innovative,” says Ajay Gannerkote, president, IDT, in a release. “This launch reflects our commitment to supporting clinical labs with trusted solutions that combine innovative technology, ease-of-use, and regulatory assurance, so clinicians can focus on their mission-critical work to find the right answers across the expanding biomarker landscape.”
Anchored Multiplex PCR at the Core
Both IVD assay kits are built on IDT’s proprietary Anchored Multiplex PCR (AMP) chemistry, designed for targeted DNA and RNA sequencing. VARIANTPlex-HT Dx focuses on variant detection, while FUSIONPlex-HT Dx targets fusion detection—two critical categories of genomic analysis in oncology care.
Each kit includes color-coded, technician- and robot-friendly reagents, adapters, and magnetic cleanup beads. Workflow steps can be run in parallel, enabling efficient library preparation and reducing hands-on time for laboratory staff—a design consideration IDT says was made with lab efficiency front of mind.
Addressing a Gap in Standardized Clinical NGS
According to IDT, the IVD-grade offerings are intended to address a recognized need among molecular pathology labs for workflows that ensure accuracy and consistency as regulatory expectations in the US and Europe continue to evolve. The company says labs have faced increasing complexity navigating the transition from laboratory-developed test environments to IVD-compliant workflows.
IDT also signaled plans to expand its Archer IVD solutions portfolio through future launches that build on the same AMP technology platform, with a stated goal of providing open access to the full range of Archer NGS assay capabilities—including novel fusion and complex variant detection for challenging sample types.
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