TX-ASURAGEN
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 .
View source version on businesswire.com: https://www.businesswire.com/news/home/20200707005261/en/
Link:
Social Media:
About Business Wire
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
2026 Mitsui Chemicals Catalysis Science Awards18.11.2025 03:00:00 CET | Press release
Online applications are open until December 25, 2025 Mitsui Chemicals, Inc. has announced that online applications for the 2026 Mitsui Chemicals Catalysis Science Award have been open since September 1, 2025. The application period will run from September 1 to December 25, 2025. Aiming to contribute to the sustainable development of chemistry and the chemical industry, Mitsui Chemicals established the Mitsui Chemicals Catalysis Science Awards in 2004. The awards consist of the Catalysis Science Award and the Catalysis Science Award for Creative Work, which recognize outstanding achievements in the field of catalysis science. To date, the awards have been conferred on 33 researchers within Japan and overseas. Past recipients include individuals who have gone on to be highly acclaimed worldwide, receiving honors such as the Nobel Prize in Chemistry and other prestigious Japanese and international awards. We welcome applications from a wide range of R&D fields, including solid catalysts,
Access Advance Welcomes Xiaomi to HEVC Advance and VVC Advance Patent Pools as a Licensor and Licensee18.11.2025 02:00:00 CET | Press release
Access Advance LLC, an independent licensing administrator for leading video codec patent pools, today announced that Xiaomi has joined the HEVC Advance Patent Pool and the VVC Advance Patent Pool, as a Licensor and Licensee. "We are delighted to welcome Xiaomi to the Access Advance licensing community," said Peter Moller, CEO of Access Advance. "Xiaomi's participation in both our HEVC and VVC patent pools represents a significant milestone in the video codec licensing landscape. Their joining of the HEVC Advance Patent Pool, which provides them with access to tens of thousands of essential patents for the widely adopted H.265 standard, and their dual role as both a licensor and licensee in the VVC Advance Patent Pool, demonstrates their commitment to innovation and the recognition of the value of patent pools that balance the interest of patent owners and implementers. In addition, it highlights their support for Access Advance’s efforts to bring a one-pool solution to video codec lic
Venture Global Files FERC Application for Plaquemines Expansion Project18.11.2025 00:02:00 CET | Press release
Today, Venture Global, Inc. (NYSE: VG) filed with the Federal Energy Regulatory Commission (FERC) its application for the permitting and approval of the Plaquemines LNG brownfield expansion project. In addition, Venture Global has filed with the U.S. Department of Energy (DOE) for the export authorizations associated with this expansion. The Plaquemines Expansion was announced earlier this year with U.S. Secretary of Energy Chris Wright, U.S. Secretary of the Interior Doug Burgum, and Louisiana Governor Jeff Landry. Venture Global has since increased the expected output from this project by nearly 40% from the previously announced plans due to the continued optimization of our liquefaction trains and strong market demand. This bolt-on expansion will be built incrementally in three phases and consist of 32 modular liquefaction trains, adding in total over 30.0MTPA in peak production capacity. This will bring the total peak production capacity across the entire Plaquemines complex to ove
Global EV Alliance Releases EV Driver Survey Results: Myths Are Slowing EV Market17.11.2025 19:19:00 CET | Press release
In a groundbreaking survey of more than 26,000 EV drivers across 30 countries, an overwhelming 77% say persistent myths about electric cars are the single biggest obstacle to EV adoption in their nations. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251118388193/en/ There are still significant differences in the EV market across countries, and not everyone has a wide range of car brands to choose from. Photo: Markus Rotevatn/Norwegian EV Association. 83% say they believe policy measures are needed to increase EV sales in their country. “Misinformation about EVs is a serious challenge. It can make policymakers less confident that electric vehicles are a viable solution to climate change and local air pollution,” says Joel Levin, chair of GEVA and Director of Plug in America. One common myth in many countries is that electric cars are a fire hazard. 88% of the EV drivers in the survey say they aren’t worried about their EV b
Dilawer Farazi Returns to Loomis Sayles as Co-Head and Portfolio Manager on the Emerging Markets Debt Team17.11.2025 16:59:00 CET | Press release
Loomis, Sayles & Company is pleased to announce that Dilawer Farazi, ACA, has rejoined the firm as Co-Head and Portfolio Manager of the Emerging Markets Debt (EMD) Team. Dilawer becomes the firm’s first London-based portfolio manager. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251117681347/en/ Dilawer Farazi, ACA, has rejoined Loomis Sayles as Co-Head and Portfolio Manager of the Emerging Markets Debt Team Dilawer brings over two decades of experience in emerging markets credit, having previously served as a Senior Credit Research Analyst at Loomis Sayles from 2018 to 2020. He rejoins the firm from Royal London Asset Management (RLAM), where he led the Emerging Markets Credit team and managed approximately USD $1 billion in assets across EM credit. At RLAM, he launched the firm’s first dedicated emerging markets funds, including an emerging markets corporate bond fund and an emerging markets short duration credit fund. I
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