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Controles externos de calidad para aplicaciones de laboratorio de biología molecular

Resumen

Tipo:
Oferta Tecnológica
Referencia:
09 IT 55Y2 3FFV
Publicado:
19/06/2015
Caducidad:
20/12/2015
Resumen:
Una pyme italiana ha desarrollado una serie de programas externos de control de calidad para diagnósticos moleculares. Todos los programas están certificados y se han desarrollado para el control de calidad de aplicaciones de laboratorio extremadamente delicadas dentro del sector de diagnósticos moleculares, específicamente para microbiología, oncología y genética. Los programas han sido diseñados para evaluar el rendimiento de un laboratorio independiente y comparar los resultados de rendimiento con el de otros laboratorios. La empresa está interesada en establecer acuerdos de joint venture y comercialización con asistencia técnica.

Details

Tittle:
External quality controls for molecular biology laboratory applications
Summary:
An Italian SME has developed a series of external quality control programmes for molecular diagnostics.
All programmes are certified and focused on quality control of the extremely delicate laboratory applications within the field of molecular diagnostics, and more specifically, in the microbiology, oncology and genetic
sectors. The company is looking for joint venture agreements and commercial agreements with technical assistance.
Description:
An Italian company has developed some External Quality Control programmes for molecular diagnostics. These programmes are certified and fall under the patronage of different scientific societies and universities. The programmes focus all on quality control of the extremely delicate laboratory applications within the field of molecular diagnostics, and more specifically in the microbiology and virology: nucleic acid extraction from biological matrices, amplification of specific targets and their detection on gel, on microplates or microchips and in Real Time PCR (polymerase chain reaction).
The programmes have been designed to precisely evaluate the performance of the single laboratory and make it possible to compare the results of each single laboratory with the performance of the other participating laboratories. Some specified applications can be jointly produced or developed within the technical cooperation foreseen.

Programmes based on screening for HPV (human papilloma virus) infection are particularly interesting, not only for the availability of the different genotypes (HPV-16, 18, 30, 31, 35, 42, 45, 51, 54, 56, 58, 59, 73) but also because the controls contain both the L1, that characterizes the viral type, and the E6/E7 regions involved in tumoral transformation of the cell.

The scientific community considers the E6/E7 regions to be the most
reliable target for screening of carcinoma of the uterine cervix since the virus may integrate within cells and lose all or part of the L1 region. Other programmes cover Herpesviridae infections such as CMV(Cyto-Megalo Virus), EBV (Epstein-Barr Virus), HSV (Herpes Simplex Virus) 1 and HSV2.

One-tube PCR internal controls containing sequences of HBV (Hepatitis B Virus), HCV (Hepatitis C Virus) or CMV, are currently
available.


Advantages and Innovations:
The company offers a series of External Quality Control programmes all of which employ a panel of cloned positive controls containing different sequences.
These positive controls can find application in a variety of assays and/or diagnostic protocols. In some cases, the positive controls may contain sequences that compete with the test target sequence during amplification. Such controls can be used for internal reaction control or to monitor the entire diagnostic process starting from the phase of extraction.
Stage of Development:
Available for demonstration
IPs:
Secret know-how

Partner sought

Type and Role of Partner Sought:
- Type of partner sought:
* Medical Microbiology Societies;
* Clinical Pathology Societies;
* Public and private clinical laboratories;
* Quality Control Industries, academies, research organisations.

- Specific area of activity of the partner: Molecular diagnostics, clinical pathology, microbiology, virology and biotechnology.

- Task to be performed by the partner sought: Increase the participant members in the Quality Control programmes offered by the company.
Type of Partnership Considered:
Joint Venture Agreement
Technical consultancy

Client

Type and Size of Client:
Industry SME 11-49
Already Engaged in Trans-National Cooperation:
No
Languages Spoken:
English
French

Keywords

Technology Keywords:
06002002 Biología celular y molecular
06001005 Diagnósticos, diagnosis
06002009 Diseño molecular
09005 Materiales de referencia
09006 Normas