Asuragen Announces CE Mark of AmplideX® SMA Plus Kit
7.7.2020 10:00:00 EEST | Business Wire | Press release
Asuragen, Inc., a molecular diagnostics company delivering easy-to-use products for complex testing in genetics and oncology, today announced CE Mark of the AmplideX® SMA Plus Kit*, an in vitro diagnostic assay to aid in the diagnosis of spinal muscular atrophy (SMA) and to identify asymptomatic carriers at risk of passing along the disease to their children. By quantifying SMN1 and SMN2 copy number, as well as detecting additional variants associated with “silent carrier” status and overall disease prognosis, the kit provides a single laboratory solution to address the unique needs of both diagnostic and screening applications.
SMA is a debilitating illness resulting from the deficient production of motor neurons in the central nervous system and is a leading genetic cause of infant death. The disease is associated with a loss of functional copies of the SMN1 gene and its severity is, largely, inversely correlated to the number of copies of SMN2. Recent studies have shown that detection of gene duplication variants in the SMN1 gene may identify “silent carriers” for the disease who may otherwise be undetected by raw copy number analysis. Furthermore, the detection of a unique SMN2 disease modifier variant suggests a milder disease phenotype and may influence patient management. Overall screening and diagnostic efforts have spiked following the recent recommendations by the American College of Obstetrics and Gynecology and the availability of novel treatments including nusinersen (Spinraza®, Biogen Idec) and onasemnogene abeparvovec-xioi (ZOLGENSMA®, Novartis).
“Our laboratory has many years of experience testing various methodologies for the quantification of SMN1 and SMN2, but the [AmplideX SMA Plus Kit] has now set the bar for speed and simplicity,” said Henny Lemmink, PhD, Clinical Laboratory Geneticist, Department of Genetics, UMC Groningen. “By incorporating reporting of silent carrier risk as well as SMN2 disease modifier presence all from the same reaction, there is no comparison on the market for getting so much information so quickly and promises to become the first choice in diagnosis and carrier screening of SMA.”
The AmplideX SMA Plus Kit* is the most comprehensive commercial offering available to support the diagnosis and carrier screening of SMA. The kit comes complete with all necessary controls, calibrators, and PCR mixes required to run the assay and features push-button, automated reporting of patient results via its AmplideX Reporter software. From just a single PCR reaction, the assay streamlines the reporting of SMN1 and SMN2 exon 7 information in less time and effort compared to current methodologies, requiring less than one hour of hands-on-time and four hours of total testing time. Similar to other products within the AmplideX product portfolio, the assay is optimized for use on the Applied Biosystems™ family of Genetic Analyzers and is compatible with a broad range of thermal cycling equipment.
“Given the emergence of novel treatments and interventions for SMA, the demand for fast and accurate test results is greater than ever,” said Matthew McManus, MD, PhD, president and CEO of Asuragen. “With the AmplideX SMA Plus Kit, laboratories how have a simple and scalable solution to deliver meaningful results in a fraction of the time compared to alternative methods.”
*CE-IVD for US export only.
About Asuragen
Asuragen is a molecular diagnostic product company changing the way patients are treated in genetics and oncology. 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.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200707005261/en/
Contact information
Lynne Hohlfeld
SVP, Corporate Development and CFO
Asuragen, Inc.
T: 512.681.5200
lhohlfeld@asuragen.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SWISSto12 and Mitsubishi Electric Corporation Announce Strategic Partnership14.9.2026 10:00:00 EEST | Press release
SWISSto12 today announced a memorandum of understanding (MoU) with Mitsubishi Electric Corporation (MELCO) (TOKYO: 6503) to pursue joint opportunities on advanced payloads, radio frequency (RF) products, and market development in Japan and the APAC region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260914982179/en/ Masahiko Arai, Executive Officer and Group President, Defense & Space Systems, Mitsubishi Electric, and Dr. Emile de Rijk, Chief Executive Officer, SWISSto12 Joint opportunities will leverage MELCO’s extensive satellite system expertise and integration capabilities together with SWISSto12’s proprietary 3D-printing designs and processes that form the foundation of its next-generation payloads—smaller, lighter, highly performant, yet built in materially shorter timeframes. The MoU underscores growing market adoption of SWISSto12’s HummingLink payload technology that leverages 3D-printing, with more than 2,000 pr
U.S. FDA Accepts New Drug Application Under Priority Review for Takeda’s Zasocitinib in Moderate-to-Severe Plaque Psoriasis, with Potential to Redefine Oral Treatment Expectations14.9.2026 10:00:00 EEST | Press release
Takeda (TSE:4502/NYSE:TAK) announced that the U.S. Food and Drug Administration (FDA) accepted its New Drug Application (NDA) under Priority Review for zasocitinib (TAK-279) for the treatment of adults with moderate-to-severe plaque psoriasis. Zasocitinib is an investigational, next-generation, highly selective and potent oral tyrosine kinase 2 (TYK2) inhibitor, which demonstrated rapid, durable and consistent skin clearance in Phase 3 plaque psoriasis studies.1-3 Addressing unmet needs in psoriasis treatment “Despite progress in psoriasis care, there remains a need for highly effective oral therapies that also address the diverse and often challenging manifestations of psoriasis, including involvement of high-impact sites like the scalp,” said Andy Plump, M.D., Ph.D., president of R&D at Takeda. “Our Phase 3 data demonstrated rapid and durable skin clearance across various patient types and in high-impact and hard-to-treat areas. Based on the results across nearly 3,000 patients, zaso
Thales Builds Cryptographic Security for the Age of AI and Post-Quantum Computing14.9.2026 10:00:00 EEST | Press release
According to the 2026 Thales Data Threat Report, the threat of Harvest Now, Decrypt Later (HNDL) attacks was the top-cited risk, with 59% of organizations reporting that they are prototyping and evaluating post-quantum cryptography (PQC) algorithms to prepare for the quantum era. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804748922/en/ ©Thales To help organizations turn this readiness into deployment,Thales, a global leader in advanced technologies, today announced the launch of Luna 8, its next-generation hardware security module. Designed for the transition to post-quantum cryptography, Luna 8 enables organizations to securely store, protect, and manage cryptographic keys with market-leading performance, scalability, and speed. As organizations face growing pressure from emerging quantum threats, expanding AI workloads and evolving stringent regulatory requirements, Luna 8 provides the performance, security and cryp
Focused Support Launches Cavok STRIKE to Expand Link-16 Participation Across the Joint Force14.9.2026 08:00:00 EEST | Press release
Focused Support LLC today announced the launch of Cavok STRIKE, an integrated software capability that expands the Link-16 tactical battlespace picture by enabling additional operational platforms to participate in the Link-16 network. Modern battlefields have increasing numbers of unmanned systems, sensors, and supporting platforms operating throughout the joint battlespace. The rapid proliferation of Group 1, 2, and 3 UAS, including both expendable and recoverable systems, has created a growing need to integrate these assets into the broader tactical network. Many of these platforms provide operationally relevant information but have historically remained outside the Link-16 network due to limitations in size, weight, power, platform integration complexity, or acquisition cost. Cavok STRIKE addresses this gap by enabling platforms to participate in the Link-16 network as non-command-and-control participants. This allows those platforms to interoperate with traditional Link-16 platfor
Fujirebio Expands Access to Blood-based Neurology Testing in Brazil with ANVISA Market Authorization for Lumipulse® G NfL Blood and Lumipulse G pTau 217 Plasma14.9.2026 08:00:00 EEST | Press release
H.U. Group Holdings Inc. and its wholly owned subsidiary Fujirebio today announced that the Brazilian Health Regulatory Agency (ANVISA) has granted market authorization for the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays for use on the fully automated LUMIPULSE® G immunoassay platform in Brazil. “ANVISA authorization of the Lumipulse G NfL Blood and Lumipulse G pTau 217 Plasma assays marks another important step in our mission to expand access to reliable, clinically meaningful blood-based biomarkers for clinicians and patients worldwide,” said Christiaan De Wilde, CEO of Fujirebio Europe N.V. “By making both neurological biomarker assays available to laboratories on a single, fully automated platform, we are helping support more informed clinical decision-making across a broad range of neurological conditions and throughout the diagnostic pathway.” The Brazilian ANVISA authorizations are based on the already CE marked in vitro diagnostics (IVD) approvals of these two
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom