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 DMPK Kit* to simplify analysis of repeat expansions within the DMPK gene, which is implicated in myotonic dystrophy type I (DM1), also known as Steinert’s disease.
DM1 is an inherited form of muscular dystrophy that affects the muscles as well as multiple other organ systems, and its severity is largely determined by the size of the CTG trinucleotide repeat expansion within the DMPKgene. These expansions commonly extend beyond a thousand CTG repeats and therefore have required the use of cumbersome Southern blot technology to estimate their size.
“The AmplideX DMPK Kit represented a significant improvement over our existing process for analyzing large DMPK expansions,” said Doctor Sophie Rondeau, PharmD, PhD, and Professor Jean-Paul Bonnefont, MD, PhD, of the Necker-Enfants Malades Hospital in Paris. “We can resolve these expansions in a fraction of the time and effort compared to Southern blot, and this finally allows us to remove that technology from our testing workflow altogether.”
The launch of the AmplideX PCR/CE DMPK Kit represents an extension of Asuragen’s portfolio of easy-to-use testing kits for complex and challenging genetic targets, including those for FMR1* and C9orf72*, and will similarly be indicated for use on widely available testing platforms. The DMPK kit is the first of several genetics products planned by the company for launch in 2018. Testing kits for SMN1&2** and HTT**, the genes implicated in spinal muscular atrophy and Huntington’s disease, respectively, are scheduled for commercial release later this year.
“Our focus this year is to significantly expand our menu of high-need genetic testing products that deliver the same quality and easy workflow that our AmplideX customers have come to depend on,” said Matthew McManus, MD, PhD, president and CEO of Asuragen. “With the launch of the AmplideX PCR/CE DMPK Kit, labs will now have the ability to accurately detect and size very large expansions in this gene within a single shift – quite a change from the multi-day workflow required by Southern blot.”
Asuragen will also be highlighting its growing product portfolio at the upcoming European Society of Human Genetics (ESHG) Annual Conference on June 16-19 in Milan, Italy. The company is sponsoring a Satellite Symposium during the meeting, New Frontiers for AmplideX Technology: Portfolio Expansion to New High Complexity Targets, on June 16 from 10.00-11.30, which will review the broad utility of AmplideX technology in overcoming the difficulties presented by these genes and how the technology puts their analysis within the reach of laboratories everywhere. The guest speakers are Isabel Marques, ErCLG, PhD, clinical laboratory geneticist from the Medical Genetics Center of Porto, Portugal and Gary J. Latham, PhD, senior vice president of research and development at Asuragen.
These new products will be featured in two scientific posters during the event’s poster sessions.
Poster Group C: 10.15 – 11.15 on Monday, June 18
Generalization of an Assay System using Repeat-primed PCR and Capillary Electrophoresis to Resolve Multiple AT- and GC-rich Short Tandem Repeats Associated with Neurological Diseases
(Gary J. Latham, PhD)
Poster Group A: 10.15 – 11.15 on Sunday, June 17
A New Powerful PCR-Based Assay for the Molecular Diagnosis of Myotonic Dystrophy Type I
(Sophie Rondeau, PharmD, PhD, Medical Genetics Unit, Necker-Enfants Malades Hospital)
The company will also have a presence at stand #482 during the conference.
* For Research Use Only. Not for use in diagnostic procedures.
** Products currently in development. Future availability and performance cannot be guaranteed.
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.