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Manufacturers Service OEM

Diatech Pharmacogenetics srl

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

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Contact

Michela Romiti

Export Manager

Phone
+390731213243

Email
michela.romiti@diatechpgx.com

Grit Lange

Business Development Manager

Phone
+390731213243

Email
lange@diatechpgx.com

Maria Luisa Biondi

Event Manager

Phone
+39 0731213243

Email
events@diatechpgx.com

Davide De Luca

Business Development Manager Oncology

Phone
+39 0731213243

Email
davide.deluca@diatechpgx.com

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Our range of products

Product categories

  • 03  Diagnostic tests
  • 03.02  Immunochemistry testing, immunology testing
  • 03.02.03  Diagnostic tests for cancer
  • 03  Diagnostic tests
  • 03.06  Genetic testing, molecular diagnostics
  • 03.06.01  DNA testing
  • 03  Diagnostic tests
  • 03.06  Genetic testing, molecular diagnostics
  • 03.06.03  Polymerase chain reaction (PCR)

Polymerase chain reaction (PCR)

Our products

Product category: Diagnostic tests for cancer

EasyPGX Real Time analysis - dry format

The qPCR solution in oncology
EasyPGX® product line – key features
Summary

  • Ready to use: reagents are delivered in 8-well strips preloaded with a complete master mix in a dry, room temperature and stable format.
  • Easy to use: no need for freezing, thawing or pipetting on ice and the few remaining pipetting steps minimize the risk of errors or contaminations.
  • High sensitivity: limit of detection as low as 0.5%.
  • Flexible sample requirement: low DNA input from a variety of sources, including FFPE and plasma.
  • Turnaround time: from tissue to result in less than 3 hours with only 10 minutes of hands-on time.
  • Quality assurance: manufactured under ISO 13485.
  • Regulatory: kits have been designed, developed and validated in accordance with the Directive 98/79/EC on in vitro diagnostic medical devices.
  • EasyPGX system workflow: from tissue to result in less than 3 hours.

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Product category: DNA testing

Easy SARS-CoV- 2 kit CE IVD 192 test Real Rime PCR

Easy® SARS-CoV-2 is an in vitro diagnostic test for the qualitative detection, by One Step Real-Time RT-PCR, of the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA from a wide range of swabs and other human clinical specimens.

All-in-one Extraction and RT-PCR: a quick and easy response for COVID-19 screening

  • Reagents for “Quick Extraction”included in the kit.
  • 96 tests in less than 3 hours including extraction
  • Fully automatic data processing with EasyPGX® Analysis Software.
EasyPGX® Analysis Software: the CE-IVD solution for data processing fully automatic

  • Developed with “wizard” to facilitate the definition, analysis and exportation of results.
  • Unique solution and platform for interactive visualization and comparison of raw data and processed results.
  • Possibility to insert patient ID with a barcode reader.Possibility to read and track codes and batches of reagents.
  • Compatible with Laboratory Information Management Systems (LIMS).
  • Reports can be customized and exported in various formats (pdf, excel)

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Product category: Diagnostic tests for cancer, DNA testing

Myriapod NGS Line

Key features:

  • Easy to use: single tube multiplex PCR.
  • Ready for diagnostics: CE IVD marked. Validated for the qualitative and quantitative evaluation of SNVs, indels and CNVs for both somatic and germline analysis.
  • Minimum quantity of DNA needed: 10-25 ng of DNA per sample.
  • Quality inside: Positive control with orthogonally validated genotype (Horizon Discovery) included in the kit.
  • Data analysis: dedicated software and workstation for automated data analysis.
The kit includes all the necessary reagents for:

  • qualitative and quantitative evaluation of the input DNA by qPCR (for somatic analysis);
  • multiplex PCR for library preparation;
  • enrichment of the library through PCR.
Myriapod® NGS Data Analysis workstation and software: from NGS raw data to clinical results

The Diatech data analysis solution is made of an easy-to-use CE IVD software running on a bespoke workstation. The software allows local analysis of raw sequencing data and the calling of SNVs, indels and CNVs. Myriapod NGS data Analysis Key features:

  • A dedicated and complete solution for local data analysis: Myriapod NGS Analysis software and the dedicated Myriapod NGS workstation are an end-to-end solution for local analysis.
  • Flexibility: same data analysis solution for both Illumina® and Thermo Fisher Scientific® platforms.
  • “Variants database” dedicated to each application The software stores all the variants detected by each application; the user can re-classify any variant for internal use.
  • Monitor progress Once the analysis has started, the user can monitor its progress in an easy way.
  • Categorized results Variants are automatically binned into categories based on quality and realiability of the call.
  • Integrated IGV data visualizer All data can be viewed with the integrated IGV viewer, allowing to visually inspect the coverage of the interested regions. Report The software allows to select sequencing metrics and results and print them in a PDF file report or export them in .csv format.
AVAILABLE KITS:
  • Myriapod BRCA1-2
  • Onco panel

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Product category: Diagnostic tests for cancer

Easy Line Real Time analysis - liquid format

The Easy® kits allow the qualitative detection of the main somatic mutations of the genes EGFR, KRAS, NRAS and BRAF by Real-Time PCR in association with a system of enrichment of the mutated allele.

  • Each kit CE IVD includes all the reagents necessary for the test and the positive controls of reaction.
  • All the kits share the same thermal profile for the detection of the somatic mutations.
Available kits:
  • KRAS
  • BRAF
  • EGFR
  • NRAS
  • ALK
  • DPYD
  • UGT1A1
  • THIROID
 

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Product category: DNA testing

Helix Line

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.

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Product category: Diagnostic tests for cancer

Myriapod NGS Line dry - Next Generation Sequencing in dry format

Myriapod NGS Dry line includes NGS panels for DNA and RNA sequencing dedicated to the study of predictive- diagnostic SNV (SNP, In/del, fusions) clinically relevant in the most frequent cancer types as: colon, lung, melanoma, central nervous system, GIST, thyroid, and bladder, and also independent tissue biomarkers, like NTRK 1, 2 and 3 gene fusions.

Main features:
  • Ready to use: Dry, ready-to-use, in pre-aliquoted strip reagent format
  • Simple: the easiest and fastest workflow on the market for NGS libraries preparation, with a hands-on time < 2 hours and a turnaround time, from sample to sequencing, of 8 hours.
  • Flexible: optimized on Illumina® Miseq™, MiniSeq™ and iSeql100™ with the flexibility to test from 2 to 46 samples/run.
  • Low amount and quality of input: validated to work from 10 ng/reactions of DNA and RNA extracted from FFPE or cfDNA.
  • Certified: fully CE-IVD protocol, from sample to result with data processing through Myriapod® NGS Data Analysis Software, fully automatic, bioinformatic analysis local system without any needs to send out data or use cloud based solutions.
Myriapod® NGS data Analysis: the CE-IVD solution for local NGS data analysis

Myriapod® NGS Data Analysis is a complete, in vitro diagnostic and easy-to-use bioinformatics solution, which come with the Myriapod® NGS Data Analysis Software and its own dedicated workstation. Myriapod NGS solution provides simplicity in the analysis for fast and easy reporting. Further, the data management system offers the highest level of security with a completely localized data analysis, so sensitive data is not sent over the network or to a cloud system. Myriapod NGS Data Analysis solution complies with all the EU General Data Protection Regulations (GDPR).

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Company news

Date

Topic

12 Nov 2020

International distributors, wanted!

Diatech is always looking for partners for the distribution of its products. Contact us if you would like to be part of our team.
If you are specialized in the sale of diagnostic devices focused on cancer, our CE IVD products may be the right way to enrich your portfolio.
Diatech is able to offer you pre and post-sales support and valued customer service that can assist you in the installation and commissioning of devices.
Please contact our export office!

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29 Oct 2020

Diagnostic test for the detection of SARS-CoV-2 virus

Following the worldwide emergency Covid-19, Diatech Pharmacogenetics announces the availability of the in vitro diagnostic test for the detection of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) .

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29 Sep 2020

Successful validation of EasyPGX PIK3CA testing

PIK3CA mutation testing - quick and easy! That this is possible was shown by our successful participation in the round robin test of PIK3CA (tissue and liquid biopsy) organized by QuiP, the external quality assessment service in Germany.
Due to the recent approval of alpelisib by the European Commission for the treatment of patients with HR +/HER2- advanced breast cancer, it is necessary that the laboratories are able to provide validated tests for PIK3CA mutations, as they will decide whether patients are eligible for treatment with alpelisib or not.EasyPGX® ready PIK3CA is a Real Time PCR-based CE-IVD test for the mutational analysis of the PIK3CA gene.

  • EasyPGX® ready PIK3CA detects the most frequent mutations of codons 345, 420, 542, 545, 546, 1047, 1049 of the PIK3CA gene.
  • EasyPGX® ready PIK3CA can be used with DNA isolated from fresh, frozen or FFPE tissue or from plasma
  • EasyPGX® ready PIK3CA turnaround time, from sample to result, is less than 3 hours with a hands-on time of 10 minutes.

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About us

Company portrait

Our group
Diatech Pharmacogenetics, in order to compete better on the molecular medicine market, has created a network of the following companies:
Diatech Labline s.r.l. a socio unico established in 2011, focused on the distribution of products and reagents for molecular biology and cellular biology labs.
www.labline.it

BiMind s.r.l. established in 2009, is a software house which has developed “iGenetics”, an innovative software package for the electronic oncological and anatomopathology clinical record.
www.bimind.it

Quality in our products
Competition in a high technology market requires strict quality control of all commercial and scientific parameters.

Diatech Pharmacogenetics has reached this goal by achieving:
  • EN ISO 9001:2015 certification
  • EN ISO 13485:2016 certification
  • Full quality assurance system
Profile
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).

Company data

Sales volume 10-49 Mio US $
Export content max. 25%
Number of employees 50-99
Foundation 1996
Area of business
  • Imaging and diagnostics / medical equipment & devices
  • Laboratory equipment
  • Diagnostics

Company information as a PDF file