XL TP53/NF1

Deletion/Isochromosome Probe

Order Number: D-5089-100-OG

Package Size: 100 µl (10 Tests)

Labels: orange green

Chromosome: 1717

Regulatory Status: IVDR

XL TP53/NF1

Deletion/Isochromosome Probe

Order Number: D-5089-100-OG

Package Size: 100 µl (10 Tests)

Labels: orange green

Chromosome: 1717

Regulatory Status: IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 for in vitro diagnostic medical devices (IVDR).

MetaSystems Probes has already certified a wide range of FISH probes, according to IVDR.

Please use the switch to change to the IVDD product.

IVDR IVDD Discover all IVDR-certified products Download Instructions For Use (IFU)

Until further notice, we will continue to provide IVDD products in various countries.

As part of our phased rollout, the IVDR-certified probes are now available in Australia, Austria, Bangladesh, Belgium, Croatia, Cyprus, Czech Republic, Estonia, France, Germany, Iceland, Italy, Jordan, Kuwait, Lebanon, Liechtenstein, Luxembourg, Malta, Nepal, Netherlands, New Zealand, Oman, Palestine, Poland, Slovakia, Slovenia, South Africa, Switzerland, Ukraine, and United Arab Emirates with the list of countries continuously expanding.

Note: Our IVDR-certified XA probes are now available across all EU countries. For more details, please visit the individual product pages.

Intended Purpose

The XL TP53/NF1 probe is a qualitative, non-automated test for the detection of isochromosomes 17q, deletions of the TP53 gene region at 17p13 and deletions of the NF1 gene region at 17q11.2 by fluorescence in situ hybridization (FISH). The product is intended as a diagnostic aid and assists in disease monitoring. The test population for the detection of isochromosome 17q consists of patients with confirmed or suspected acute myeloid leukemia (AML), chronic myeloid leukemia (CML), myelodysplastic neoplasms (MDS) and non-Hodgkin-lymphomas (NHL). The test population for the detection of deletions of the TP53 gene region consists of patients with confirmed or suspected acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL), myelodysplastic neoplasms (MDS), multiple myeloma (MM) and non-Hodgkin-lymphomas (NHL).The test population for the detection of deletions of the NF1 gene region at 17q11.2 consists of patients with confirmed or suspected acute myeloid leukemia (AML), chronic myelomonocytic leukemia (CMML), myelodysplastic neoplasms (MDS) and myeloproliferative neoplasms (MPN). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for ALL, AML, CLL, CML, CMML, MDS and MPN, on methanol/acetic-acid fixed plasma cells for MM and on methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.

Product Description

The XL TP53/NF1 probe consists of an orange-labeled probe hybridizing to the TP53 gene region at 17p13 and a green-labeled probe hybridizing to the NF1 gene region at 17q11.2.

Probe maps for selected products have been updated. These updates ensure a consistent presentation of all gaps larger than 10 kb including adjustments to markers, genes, and related elements. This update does not affect the device characteristics or product composition. Please refer to the list to find out which products now include updated probe maps.

Probe map details are based on UCSC Genome Browser GRCh37/hg19, with map components not to scale.

Need assistance or a quote?