The story previously incorrectly stated the test is a liquid biopsy. In fact, the test is blood-based but not a liquid biopsy.
NEW YORK — Dutch diagnostics firm MRC Holland said Thursday that its blood-based test for Peutz-Jeghers syndrome has been certified under Europe's In Vitro Diagnostic Regulation (IVDR).
Peutz-Jeghers syndrome is an autosomal dominant disorder characterized by benign gastrointestinal polyps, hyperpigmented skin spots, and an increased risk of certain cancers.
MRC Holland's assay — called SALSA MLPA Probemix P101 STK11 — is designed to detect disease-associated deletions in the STK11 gene in genomic DNA isolated from whole-blood samples. It is intended to confirm a potential cause of Peutz-Jeghers syndrome and for the genetic testing of at-risk family members.
MRC Holland has received IVDR certification for a number of its products in recent months including blood-based assays for spinal muscular atrophy and various tests for hereditary breast and ovarian cancer syndrome earlier this year.