Molecular diagnostics company Asuragen has secured CE mark approval for its AmplideX SMA Plus Kit to diagnose spinal muscular atrophy (SMA).

AmplideX SMA Plus Kit is an in vitro diagnostic assay that will help in the diagnosis of SMA, as well as to detect asymptomatic carriers at risk of passing along the disease to their children.

The kit offers a single laboratory solution to address the needs of both diagnostic and screening applications by quantifying SMN1 and SMN2 copy number and identifying additional variants associated with silent carrier status and overall disease prognosis.

SMA is a debilitating illness that causes due to the insufficient production of motor neurons in the central nervous system. It is said to be a major genetic cause of infant death.

The new kit, which efficiently supports the diagnosis and carrier screening of SMA, includes all required controls, calibrators, and PCR mixes needed to run the assay.

Asuragen’s kit also features push-button and facilitates automated reporting of patient results through its AmplideX Reporter software.

The assay streamlines the reporting of SMN1 and SMN2 exon 7 information within short time from a single PCR reaction.

The assay from Asuragen is compatible with a range of thermal cycling equipment

According to the company, the assay also enables to save one hour of hands-on-time and four hours of total testing time compared to total testing time.

Designed to be compatible with a range of thermal cycling equipment, the assay can be used on the Applied Biosystems family of genetic analysers.

Asuragen president and CEO Dr Matthew McManus said: “Given the emergence of novel treatments and interventions for SMA, the demand for fast and accurate test results is greater than ever.

“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.”

In March, Asuragen developed an Armored RNA Quant SARS-CoV-2 Control to be employed in developing assays to combat the Covid-19 (coronavirus) pandemic.