ASURAGEN INC.

Company Overview

Asuragen develops and markets molecular diagnostic products based on its position in miRNA. The company provides targeted next-generation sequencing for detection of clinically actionable mutations from DNA samples.

The company’s main platforms include AmplideX and QuantideX. Tests are offered using either PCR or NGS. The main NGS-based test is the QuantideX NGS Pan Cancer Kit, which profiles mutations in 21 genes related to a wide range of human cancers.

Asuragen participates in the clinical sequencing industry by offering kits for NGS analysis of ctDNA. These kits allow for targeted amplicon sequencing and bioinformatics analysis and can be used by laboratories performing liquid biopsy tests.

In November 2019, Asuragen formed an alliance with Wave Life Sciences to develop a companion diagnostic for Huntington’s Disease therapies.

In February 2020, the U.S. FDA authorized marketing of Asuragen’s AmplideX Fragile X Dx and Carrier Screen Kit, the first genetic test for fragile X syndrome (FXS). This test is used to help diagnose FXS and also for use in adults who may be carriers of genetic alterations in FMR1, the gene associated with FXS.

The test was approved after demonstrating 95% diagnostic accuracy in clinical trials. The test uses a method called triplet repeat primed PCR (TP-PCR) to measure the number of repeats of the CGG segment in the FMR1 gene, using blood samples. The test assigned the number of CGG repeats as being normal, intermediate, premutation, or full mutation.

In August 2020, Asuragen partnered with Pacific Biosciences to develop clinical and research assays using PacBio’s single-molecule, NGS technology. The initial focus of this alliance was on development of a carrier screening assay. The alliance is important in moving long read sequencing technologies towards clinical applications.

In March 2021, Bio-Techne Corp. signed an agreement to acquire Asuragen Inc. In November 2021, the company launched a new kit, AmplideX PCR/CE CFTR Kit, to identify pathogenic variants in the CFTR gene. In December 2022, Asuragen collaborated with Oxford Nanopore Technologies plc (Oxford Nanopore) to manufacture an assay designed to offer more accurate and reliable reproductive carrier screening.

Company's Business Segments

• Genetics : Asuragen's Genetics segment solves unmet testing needs in Inherited Genetic Disorders by leveraging expertise in reliable Amplification of GC-rich, High Homology Target Sequences.
• Oncology : Asuragen’s portfolio of Precision Oncology solutions delivers Sensitive, Reproducible results using innovative techniques in a Streamlined, Multiplex Workflow.
• Companion Diagnostics : Asuragen’s Companion Diagnostics products feature all of the necessary components – Reagents, Controls, Automated Software – to deliver Quality, Accurate results in any Laboratory around the world.
• Molecular Quality Controls : Asuragen provides High Quality, Custom Molecular Diagnostics controls by leveraging a combination of Product Development, Manufacturing Expertise.