Gold
Post-natal CMA test reimbursement started preliminary reimbursement since August 2019. This passed conformity assessment this June and it will be changed to regular reimbursement item. We consider what this change means and what impact it may have on patients and their families in the future.
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The CytoScan Dx Assay is a qualitative assay intended for the postnatal detection of chromosomal copy number variants (CNV) in genomic DNA (gDNA) obtained from peripheral whole blood in patients referred for chromosomal testing based on clinical presentation. The CytoScan Dx Assay is the first and FDA-cleared chromosomal microarray test to aid in the identification of the underlying genetic cause of developmental delay, intellectual disability, congenital anomalies, or dysmorphic features in children. Assay results are intended to be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice including confirmation by alternative methods, parental evaluation, clinical genetic evaluation, and counseling as appropriate. Interpretation of assay results is intended to be performed by healthcare professionals board certified in clinical cytogenetics or molecular genetics. The assay is intended to be used on the GeneChip System 3000Dx and analyzed by Chromosome Analysis Suite Dx Software (ChAS Dx Software).
Prepare samples efficiently from a variety of materials with the Thermo Scientific KingFisher Flex Purification System, which offers highly versatile, automated magnetic-particle processing for DNA/RNA, protein, or cell purification from virtually any source. Using revolutionary magnetic particle separation technology, this system provides excellent reproduciblity and quality. Features of this KingFisher Flex Purification System package include: • Fully automated system yields high-speed purification of nucleic acids, proteins, and cells • High-throughput system processes up to 96 samples in less than 20 minutes • Open and flexible system lets the customer use any magnetic particle-based kit to meet the application demands • Easy-to-use BindIt Software provides instrument control, protocol creation, and modification • Ready-made protocols available for different type of applications • 1-day SmartStart Orientation to get you up and running quickly