MPLN expands cystic fibrosis offering with a comprehensive range of molecular testing options to support all clinically relevant indications for CFTR testing. MPLN’s offering includes testing for screening, diagnostic and therapeutic applications with particular emphasis on expanding mutation detection for ethnically diverse populations. The illumina CF-139 Next Generation Sequence (NGS) assay is the largest panel of clinically relevant and functionally verified variants as defined in the CFTR2 database and will detect most mutations targeted by the CFTR potentiator KALYDECO® (Ivacaftor).
MPLN's molecular testing offerings include:
Screening Panel (39 mutations) M CF 39 The Luminex xTAG® Cystic Fibrosis (CFTR) 39 kit v2 (IVD)
Expanded pan-ethnic Panel (139 mutations) M CF NGS 139 The illumina MiSeqDx® Cystic Fibrosis 139-Variant Assay (IVD)
Full gene sequence M CF NGS SEQ The illumina MiSeqDx® Cystic Fibrosis Clinical Sequencing Assay (IVD)
MPLN has approval from New York State Department of Health to provide Cystic Fibrosis genetic testing. The tests offered by MPLN are FDA IVD cleared and include screening, diagnostic and therapeutic applications.
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