Microarray-Products of Conception (POC) Reveal® FFPE, Data Transfer

Formalin fixed paraffin embedded (FFPE) tissue

One paraffin block or ten 10-micron thick section slides

Extracted DNA from received specimen must yield at least 10 ul at a concentration of 8 ng/ul.

Paraffin block transport pouch

For products of conception samples, this test will detect chromosomal imbalance that could be associated with developmental delay/congenital anomalies. It provides detection of possible uniparental disomy of any chromosome, the percent and location of homozygosity, including the degree of identity by descent. For oncology samples, this test will detect chromosomal imbalances that may be present in neoplastic disorders and clonal evolution. It provides detection of copy-neutral loss of heterozygosity of any chromosome, and the percent and location of homozygosity, that may be associated with cancer gene mutation.

This SNP assay does not detect balanced rearrangements, low-level mosaicism (<10%), marker chromosomes that only contain heterochromatin or tetraploidy. Genotypes in some formalin-fixed tissues are unable to be determined, allowing only genomic dosage to be determined.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.

SNP Microarray analysis is performed using the Oncoscan® FFPE platform, which uses more than 220,000 SNP probes with a median spacing of 5.0kb, within the majority of genes.