AUSTIN, Texas — (BUSINESS WIRE) — Asuragen, Inc., a molecular diagnostics company delivering high-quality, easy-to-use products for complex testing in genetics and oncology, today announced the launch of the AmplideX® PCR/CE SMN1/2 Kit*. Building upon the simple testing workflow of the AmplideX PCR/CE SMN1 Kit* which launched last year, this new assay quantifies both SMN1 and SMN2 exon 7 copy number in less than four hours from a single PCR reaction. The assay shares a common testing workflow with all other assays in the AmplideX portfolio and is similarly optimized for use on broadly installed Applied Biosystems™ Genetic Analyzers.
“The Amplidex PCR/CE SMN1/2 Kit is streamlined, easy-to-use, and scalable,” said Elizabeth Berry-Kravis, MD, PhD, co-director of the molecular diagnostics section of the genetics laboratory and professor of pediatrics at Rush University Medical Center. “It has the potential to provide rapid, robust, molecular characterization of SMN1 and SMN2 copy numbers that we need now for diagnosis, prognosis, carrier screening, characterization and binning for treatment trials, and for efficient rapid insurance approvals for these patients where every week counts.”
Interest in SMN1 and SMN2 copy number quantification has grown considerably in recent years following the 2016 FDA approval of nusinersen (Spinraza®, Biogen Idec) for the treatment of spinal muscular atrophy, a debilitating illness resulting from deficient production of motor neurons in the central nervous system. The disease is attributable to loss of functional copies of the SMN1gene, and its severity is inversely correlated with the number of copies of SMN2. In its most severe forms, the disease is invariably fatal without timely therapeutic intervention.
“We tested clinical samples spanning a broad range of SMN1 and SMN2 copy numbers with the AmplideX PCR/CE SMN1/2 Kit,” said Rosário Santos, PhD, laboratory head of the Molecular Genetics Unit at the Centro Genética Médica Dr. Jacinto Magalhães, Centro Hospitalar Porto in Porto, Portugal. “We observed near perfect concordance with our in-house method and it delivered results in a fraction of the time using a simple workflow. We also explored the impact of using different DNA isolation procedures prior to testing and each had little to no impact on the results, a testament to the assay’s quality and robustness.”
The AmplideX PCR/CE SMN1/2 Kit* is the latest in a series of Asuragen product launches for genetics and oncology, with reagent test kits for the analysis of SMN1*, DMPK*, and HTT*, and somatic mutation hotspots in cancer*, each becoming available within the last year. Recent neurogenetics assays demonstrate the versatility of AmplideX technology for multiple applications, including copy number variation and repeat expansion sizing, with a common workflow streamlining the testing process across multiple genomic targets.
“This latest addition to our growing portfolio showcases our proprietary chemistries’ unique abilities to provide simple testing solutions for the genome’s most difficult targets,” said Matthew McManus, MD, PhD, president and CEO of Asuragen. “By streamlining and simplifying the testing process, the AmplideX PCR/CE SMN1/2 kit gives labs everywhere the ability to analyze these critically important but very challenging genes.”
* For Research Use Only. Not for use in diagnostic procedures.
Asuragen is a molecular diagnostic company changing the way patients are treated in genetics and oncology. The quality, simplicity and sensitivity of its products brings precision medicine within reach. Asuragen’s diagnostic systems, composed of proprietary chemistry and software, deliver powerful answers using broadly installed instrument platforms. They are simple to adopt and expand the ability to serve patients. Asuragen is a product foundry rapidly and efficiently addressing current and emerging clinical needs, including cancer diagnosis and monitoring, reproductive health and aging, serving laboratories across a patient’s lifespan with its best in class diagnostic tests. For more information, visit www.asuragen.com.
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