Medical Products Supplies Companies

Via Ignazio Silone 1b, 60035 Jesi
Italy
Telephone +39 0731 213243
Fax +39 0731 213239
export@diatechpgx.com

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Product categories

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.03 Diagnostic tests for cancer

Diagnostic tests for cancer

03 Diagnostic Tests
03.06 Genetic testing, molecular diagnostics
03.06.01 DNA testing

DNA testing

03 Diagnostic Tests
03.06 Genetic testing, molecular diagnostics
03.06.02 Molecular biomarkers

Molecular biomarkers

03 Diagnostic Tests
03.06 Genetic testing, molecular diagnostics
03.06.03 Polymerase chain reaction (PCR)

Polymerase chain reaction (PCR)
Our products

Product category: DNA testing
Titano MSI kit
Titano MSI kit allows the determination of microsatellite instability status in colorectal cancer samples by multiplex amplification with fluorescent primers and subsequent DNA fragment analysis on an automated sequencer.

Target markers: Bethesda panel (BAT25, BAT26, D2S123, D17S250, D5S346), BAT40, D18S58, NR21, NR24, TGFßRII.
Control markers for the detection of possible contamination or samples mixups: TPOX, TH01.

The kit allows the analysis of DNA extracted from fresh, frozen or para nembedded tissues and from peripheral blood.
The procedure consists of four multiplex amplifications with the same thermal profile, followed by two capillary electrophoresis runs for each sample, and it can be completed in 5 hours.

Titano MSI kit is available in a 24 tests size (code FA001). It contains all necessary reagents for the amplification step and a human genomic DNA as reaction positive control.

The kit is CE-IVD marked and has been validated on ABI 3130/3130XL or ABI 310 Genetic Analyzer.

Product category: DNA testing
Helix® Circulating
The kit allows the manual extraction of circulating free DNA (cfDNA) from plasma. The kit Helix® Circulating Nucleic Acid, in association with the kit Easy® EGFR, enables the mutational analysis of EGFR gene in the circulating tumor DNA (liquid biopsy) when the tumor tissue is not evaluable, according to the EMA/129677/2014 recommendations of September 25th 2014.

Product category: DNA testing
RealQuant®
The RealQuant® Lung Fusion Genes kit allows to detect by 45 molecular probes, in a single multiplex reaction, known and unknown fusion variants of ALK, ROS1 and RET starting from RNA extracted from fresh, frozen or paraffin tissue, or from cytological samples. In the same multiplex are included further 27 assays and related probes: 21 for reference genes necessary for data normalization and 6 for genes differentially expressed in normal and tumor lung tissue, useful for the evaluation of RNA quality and quantity and for neoplastic cell content.
In less than two days it is possible to move from the biological sample to standardized results and readily usable for the report, thanks to a dedicated software for NanoString® (RealQuant® Data Analysis Software) data analysis, that, among the other functions, performs the quality control and the evaluation of the analytical and pre-analytical steps.
The RealQuant® Lung Fusion Genes performances have been evaluated during a multicenter clinical study (LEONID1) in comparison with FISH, IHC and Real Time PCR. The concordance with the others methodologies was greater than 97%. The NanoString® technology, based on the hybridization of molecular probes (fluorescents barcode), allow the detection and quantification of a very high number of different target sequences (up to 800 in the same multiplex reaction), with only 4 pipetting steps and 15 minutes of “hand on-time”, reaching exceptional performances even on samples with low quantity and quality.

The innovative 3D Biology™ version of NanoString® technology also provides a multi-functional approach for the analysis of RNA, DNA (SNP, indel, CNV) and proteins in the same reaction tube.

The validation was performed in a clinical study in collaboration with the Surgical, Medical, Molecular and Critical Areas department, University of Pisa – Pisana (Pisa) University Hospital, and with the Level III Biosciences, Molecular Diagnostic laboratory – Biomarkers and personalized medicine, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.) IRCCS (Meldola).

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About Us

Company details
Diatech Pharmacogenetics is the Italian leader in the development, production and commercialisation 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 it revenues in R&D.
Diatech Pharmacogenetics is able to take pharmacogenetics tests from idea to market on a variety of platforms, from real-time PCR to barcoded microarrays, mass-spectrometry and next generation sequencing, supplying all reagents, instruments, materials and support necessary. Its complete solutions guide diagnostic operators from sample extraction, quality control, molecular assay to bioinformatic analysis and report.
The latest products launched include a liquid biopsy cfDNA extraction kit, a real-time PCR system with all reagent provided in a dry and stable format, micro-satellite instability assays and an end-to-end NGS solution that works on both Illumina and IonTorrent platforms.
All Diatech products are developed under EN ISO 9001 and EN ISO 13485 and have been designed, developed and validated in accordance with the Directive 98/79/EC on in vitro diagnostic medical devices (CE-IVD).

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