Market Overview

Asuragen Expands AmplideX® Technology and Product Line with Launch of PCR/CE SMN1 Kit


The AmplideX PCR/CE SMN1 kit allows laboratories to quickly and
easily determine SMN1 exon 7 copy number

, 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

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 SMN1
copy 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.

About Asuragen

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

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