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 Kit*. This kit extends the company’s proprietary AmplideX technology to include the quantification of gene copy number variations by providing a simple and scalable determination of functional SMN1 copy number in as few as four hours. The assay is compatible for use on the suite of Applied Biosystems capillary electrophoresis instruments and leverages Asuragen’s AmplideX® Reporter software for automated and streamlined reporting of results, further easing laboratory adoption and implementation.
Spinal muscular atrophy (SMA), a debilitating illness resulting from deficient production of motor neurons in the central nervous system, is attributable to the loss of functional copies of the SMN1 gene. Interest in screening for SMN1 copy number has grown considerably following the FDA approval of nusinersen (Spinraza®, Biogen Idec) in 2016 and the subsequent carrier screening recommendation from the American College of Obstetricians and Gynecologists (ACOG) in 2017. It is estimated that approximately 1 in 50 individuals is a carrier for the disease.
The launch of the AmplideX PCR/CE SMN1 Kit represents not only an extension of Asuragen’s technology into a new disease area, but also highlights the versatility of the AmplideX approach moving beyond detection of repeat expansions. “With this product, we are demonstrating that with a simple, common workflow, we can address a wide spectrum of testing needs and laboratory challenges in genetics and oncology,” said Matthew McManus, MD, PhD, president and CEO of Asuragen. “The AmplideX PCR/CE SMN1 kit allows laboratories to quickly and easily assess SMN1copy number using a workflow they’ve come to appreciate and trust.”
The AmplideX portfolio of PCR/CE based test kits for genetic targets also includes FMR1*†, DMPK*, C9orf72* and TOMM40*. Future expansion includes the AmplideX PCR/CE SMN1/2 Kit**, the AmplideX PCR/CE HTT Kit**, and the AmplideX PCR/CE CFTR Kit**, all of which will share the established and easy-to-implement workflow common across all AmplideX products.
* For Research Use Only. Not for use in diagnostic procedures.
† CE-IVD. For US export only.
** Product in development. Specifications not finalized.
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.
Lynne Hohlfeld, 512-681-5200
SVP, Corporate Development & CFO