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Dx Focus: Meridian Illumigene Assays; Biofactory FMR1 Identification Kit


Meridian Bioscience said this week that it has received medical device license approval from Health Canada to market its Illumigene Mycoplasma and Pertussis assays.

The Illumigene Mycoplasma test amplifies specific DNA from Mycoplasma pneumonia to detect the bacterium and help patients receive appropriate treatment in a timely manner. Meantime, Illumigene Pertussis amplifies a specific DNA target to detect Bordetella pertussis from nasopharyngeal swabs.

Both tests are already approved by the US Food and Drug Administration, and are based on Meridian's illumigene platform, which uses loop-mediated isothermal amplification. The Illumigene assays run on the company's illumipro-10 instrument and generally provide results in less than an hour.

Somagen Diagnostics and Meridian inked a deal in 2008 to distribute Meridian's products in Canada. In a statement, Somagen President Elena LoCastro said that the two illumigene tests are the first standalone mycoplasma and pertussis molecular assays to receive medical device license approval from Health Canada.

"The addition of the Illumigene mycoplasma and pertussis products to the illumipro-10 test menu offers current illumipro-10 system users within our laboratories the opportunity to further enhance their workflow and efficiencies," she said. "In addition, the launch of these new products combined with the existing illumigene test menu offers an attractive solution for further growth and expansion of our installed system base in Canadian medical laboratories."

Biofactory said this week that its FastFraX FMR1 Identification Kit has garnered CE marking and is now available for sale in Europe.

The new test uses PCR to detect and enable screening of mutations in the Fragile X mental retardation (FMR1) gene causing Fragile X syndrome. More specifically, the test amplifies the mutation from patient DNA samples and analyzes the amplification products using melt curve analysis to rapidly identify individuals with aberrant repeated DNA sequences in the gene.

"This PCR-only test is more straightforward than current detection methods, providing a faster and more cost-effective option for large-scale screening," Theodore Tan, managing director at Singapore-based Biofactory, said in a statement. He also noted that the test can similarly identify Fragile X-associated disorders such as primary ovarian insufficiency and ataxia.

"This is the first test in the field that, in the true sense, enables FXS screening," Guan Ming, scientific director at the company, said in a statement. "Thousands of samples can now be sorted … without needing Southern blot or capillary electrophoresis. The FXS testing procedure will be greatly streamlined because the test requires minimal hands-on time and the results are obtained in under six hours."

The FastFraX FMR1 Identification Kit is the first of Biofactory's series of kits to achieve CE mark. Two other kits that analyze and confirm FXS are in the process of obtaining certification and will be launched later this year: the FastFraX Sizing Kit and FastFraX Methylation Status Kit, both of which analyze samples flagged by the FMR1 Identification Kit. The sizing kit measures the number of aberrant repeated DNA sequences, providing information about carrier status and risk of Fragile X-associated disorders. The methylation status kit determines if the defective FMR1 gene produces protein and confirms if an individual has FXS.

Together, the complete suite of FastFraX test kits equips genetic laboratories to better analyze the severity of FMR1 gene mutation in patient samples, Biofactory said.