Diatech | Details

DIATECH PHARMACOGENETICS

Diatech Pharmacogenetics is the Italian leader in the development, production, and commercialization of pharmacogenetics tests for cancer precision medicine.
Founded in 1996, Diatech Pharmacogenetics has sustained constant organic growth over the years and now owns more than 70% of the Italian molecular diagnostic market and it is rapidly growing worldwide; to date, more than 20.000 diagnostic tests have been performed using its solutions and every year Diatech Pharmacogenetics reinvests 20% of its revenues in R&D.

Key Features:

Covers 19 prominent Genes related to Solid Tumors.
Reagents for PCR: Completely Lyophilized and Ready to use.
Extraction kit included: FFPE Extraction kits are included for DNA-based kits.
Type of Sample: FFPE and Cell-Free DNA/RNA
Throughput capability: Can perform multiple genes in a single run, as the PCR conditions are the same across all DNA-based tests and RNA-based tests.
TAT: Sample Entry to result in less than 90 minutes per assay.

EGFR Detection of the main mutations of exons 18, 19, 20, 21 of the EGFR gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene

KRAS Detection of the main mutations of exon 2 (codons 12, 13), of exon 3 (codons 59, 61) and of exon 4 (codons 117, 146) of the KRAS gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

NRAS Detection of the main mutations of exon 2 (codons 12, 13), of exon 3 (codons 59, 61) and of exon 4 (codons 117, 146) of the NRAS gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

BRAF Detection of the main mutations of codon 600 of the BRAF gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

BCR-ABL QUANTITATIVE ASSAY P190 EasyPGX® ready BCR-ABL p190 are in vitro diagnostics real time PCR assays for detection and quantification of BCR/ABL fusion trascripts starting from RNA extracted by pheripheral whole blood or bone marrow

BCR-ABL QUANTITATIVE ASSAY P210 EasyPGX® ready BCR-ABL p210 are in vitro diagnostics real time PCR assays for detection and quantification of BCR/ABL fusion trascripts starting from RNA extracted by pheripheral whole blood or bone marrow

BCR-ABL QUALITATIVE EasyPGX® ready BCR-ABL Fusion (code RT038 – 48 test CE IVD) is a validated kit for in vitro diagnostic use for the qualitative detection and discrimination of BCR-ABL fusion variants in samples isolated from bone marrow, peripheral blood and leukocyte suspensions. Simultaneous detection and discrimination of the isoforms of p210, p190 and p230

CBFB-MY H11 “EasyPGX® ready CBFB-MYH11 Fusion” kit is an in vitro diagnostic test for the detection by One Step Real-Time PCR of CBFB-MYH11 A, D and E fusions caused by inv(16)/t(16;16).

AML-ETO “EasyPGX® ready AML1-ETO Fusion” kit is an in vitro diagnostic test for the detection by One Step Real-Time PCR of AML1-ETO t(8;21) fusion

PML-RARA QUALITATIVE “EasyPGX® ready PML-RARA Fusion“ kit is an in vitro diagnostic test for the detection by One Step Real-Time PCR of PML-RARA bcr1 (long, L-form), bcr3 (short, S-form) e bcr2 (variant, V-form) fusions.

MICROSATELLITE INSTABILITY ASSAY (MSI) Detection of 8 mononucleotide “quasi – monomorphic” markers: BAT-25, BAT-26, NR-21, NR-22, NR-24, NR-27, CAT-25 and MONO-27 by Real Time PCR and subsequent analysis of the targets based on the denaturation profile. The test allows, accurately and with reduced “hands-on time”, to detect the microsatellite instability in tumor samples.

PIK3CA Detection of the main mutations of codons 345, 420, 542, 545, 546 1047 and 1049 of the PIK3CA gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

NTRK FUSIONS Detection of the main mutations of codons 345, 420, 542, 545, 546 1047 and 1049 of the PIK3CA gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

ALK-RET-ROS-MET Detection of the main chromosomal translocations involving ALK, ROS1, RET and the MET exon 14 skipping. Each mix allows the co-amplification of one or more fusions plus an endogenous control gene.

IDH-1;2 Detection of the main mutations of exon 2 (codons 12,13), of exon 3 (codon 61) of the KRAS, NRAS, HRAS genes and of the codons 600 and 601 of the BRAF gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

THYROID FUSION Detection of the main mutations of exon 2 (codons 12,13), of exon 3 (codon 61) of the KRAS, NRAS, HRAS genes and of the codons 600 and 601 of the BRAF gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

THYROID RAS PANEL Detection of the main mutations of exon 2 (codons 12,13), of exon 3 (codon 61) of the KRAS, NRAS, HRAS genes and of the codons 600 and 601 of the BRAF gene. Each mix allows the co-amplification of one or more mutated alleles plus an endogenous control gene.

DPYD Detection of the main chromosomal translocations involving ALK, ROS1, RET and the MET exon 14 skipping. Each mix allows the co-amplification of one or more fusions plus an endogenous control gene.

UGT1A1 Detection of the main chromosomal translocations involving ALK, ROS1, RET and the MET exon 14 skipping. Each mix allows the co-amplification of one or more fusions plus an endogenous control gene.

Helix Circulating DNA Extraction Kit The kit allows the manual extraction of circulating free DNA (cfDNA) from plasma. The kit Helix® Circulating Nucleic Acid, in association with the kit EasyPGX® ready EGFR, enables the mutational analysis of EGFR gene in the circulating tumour DNA (liquid biopsy) when the tumour tissue is not evaluable, according to the EMA/129677/2014 recommendations of September 25th 2014. DNA capture by silica membrane and vacuum-based system. The system to concentrate the final eluate up to 3 times is included in the kit.

HPV GENOTYPING KIT Identification of 14 High Risk genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68) of Human Papilloma Virus (HPV) by amplifying the E6 and E7 oncogenes. Each mix allows the co-amplification of the genotype-specific HPV targets plus an endogenous control gene.