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The Pathologist / Issues / 2025 / Feb / Solutions for Clinical & Research Laboratories

Solutions for Clinical & Research Laboratories

Empowering you to provide better answers through effective, streamlined solutions for genetics and oncology.

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Asuragen, a Bio-Techne Brand, provides best-in-class molecular diagnostic products to improve the way patients are treated in genetics and oncology. Our diagnostic systems, which include proprietary chemistry and software, are designed for use with widely available instruments to ease adoption and quickly expand lab test menus. Our diagnostic tests address current and emerging clinical needs in reproductive health, cancer monitoring and inherited disease. Our all-inclusive kitted products and analysis software allow researchers and clinicians to achieve consistent, streamlined results, enabling you to provide better answers.

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With Exosome Analysis, Highly Sensitive Monitoring of ESR1 Mutations is Possible

With the rise of precision oncology therapies — particularly those that target specific variants or remain effective despite specific mutations — there is more need than ever for routine, highly sensitive detection of the cancer mutations that arise during the course of a patient’s treatment journey.

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ESR1 & Beyond: Leveraging Exosomes for Highly-Sensitive Variant Detection on qPCR

In this workshop, we will showcase the design and performance of the QuantideX® qPCR ESR1 exoMutation Kit* combined with the ExoLution™ Plus cfDNA/exosomal RNA Isolation Kit* to deliver sensitivity of ≤0.1% for 11 ESR1 mutations located in the ligand-binding domain. By utilizing the power of cfDNA and exosomal RNA isolated from exosomes, the kit delivers best in class performance.

Verification of a Highly Sensitive, Circulating Cell-Free DNA and Exosomal RNA RT-qPCR Assay System to Monitor ESR1 Mutations from a Liquid Biopsy

Mutations in the ligand binding domain of the estrogen receptor gene (ESR1) are the leading cause of resistance to aromatase inhibitor therapy. Early identification of ESR1 mutations in plasma is critical after progression on AI therapy in alignment with recent NCCN guidelines. View the performance of an assay that detects 11 ESR1 acquired resistance mutations from plasma liquid biopsies that utilizes RT-qPCR technology combined with a novel isolation method that captures exosomal RNA in addition to cfDNA to improve mutation detection sensitivity.

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Interpreting Variants with the AmplideX® PCR/CE SMN1/2* Plus and SMA Plus† Kits

In this technical note, we discuss the latest clinical research on the variants detected by this kit, including how they relate to the underlying genetics and outcomes for spinal muscular atrophy disease prognosis and carrier risk.

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Long-Range PCR Meets Long-Read Sequencing: An Assay for 11 Hard-to Decipher, High-Frequency Carrier Screening Associated Genes

In this workshop, Dr. Wadsworth of Stanford University will discuss the design and performance of the AmplideX® Carrier Plus Kit*, combining Amplidex chemistry with the Oxford Nanopore® platform to identify the most challenging genetic alterations like CNVs, large inversions, and pseudogenes using a consolidated workflow.

Verification of an Amplification Based Nanopore Sequencing Assay and Software to Genotype Complex, Clinically Relevant Variants in 11 Hard-to-Decipher Genes with High Carrier Frequencies

Although NGS is a widely used method for genetic characterization, it fails to resolve many variants in genes that have complex pathogenic elements like repeats, structural variation, and pseudogenes. To address this shortcoming for researchers, we combined short- and long-range PCR enrichment with nanopore sequencing in a kit-based modular panel to accurately genotype traditionally NGS addressable genes and hard-to-decipher genes, in a single streamlined workflow.

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Accelerating the Drug Development Journey

Bio-Techne offers a suite of precision medicine services spanning translational biomarker discovery through clinical trial assay and downstream development, as well as commercialization of companion diagnostic products. As part of these services, Asuragen, a Bio-Techne brand, has developed a multiplex, RT-qPCR assay system for which clinical and analytical performance has been demonstrated in multiple disease indications.

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*For research use only. Not for use in diagnostic procedures.

†CE-IVD for U.S. Export Only

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