Proof of concept has been validated

During the first phase, the proof of concept has been validated: the combination of PCRm and DNA chips permitted to identify the specific genetic characteristics of pathogens (bacteria and viruses at a time) and some resistance factors on known samples.

Including, the following points were developed and/or validated:

– The primary format (96-well plate ELISA)

– Testing the support (TKL adhesive based on patent held by AXO)

– Detection by colorimetry and automation of the test,

– Multiplexed detection, by the test of compounds pools of several samples of known pathogens,

– Possibility of detecting several types of characteristics: target genes from bacteria and viruses, resistance factors,

– Recent optimization of PCR conditions allowed to detect higher number of the targeted genes and to increase the sensitivity of other target genes.

– Development of the complete automated analytical protocol

 

Product foreseen will be designed to be adaptable to existing laboratory equipment: extraction, PCR amplification, automated liquid handling. The minimum required apparatus will be (i) a thermocycler and (ii) a microplate imager. For high-throughput needs, an automated liquid handler can run the full process (PCRm, hybridization assay on microarrays in plates, and reading). Based on the proof on concept and first results, performances of the test will be assessed (selectivity, sensibility).

Respiratory Pathogens Multiplex Detection

Respiratory Syndrome Linked Pathogens Multiplex Detection and characterization

ANR – Program TecSan 2013 – ReSynPlex

ANR-label-bleu-CMJN

DGARespiratory infections are a major threat to human health. According to WHO, respiratory infections are the cause of 60 % of deaths in the category “diseases, maternal and perinatal conditions and nutritional deficiencies” in France and Europe. Respiratory infections are the primary cause of death in developing countries. Worldwide, they are responsible for more than 5 million deaths per year, i.e. 10 000 to 15 000 deaths per day. In industrialized countries, respiratory infections are one of the main causes of outpatient consultations.

The effort of the clinician to characterize the aetiology of a patient’s syndrome is a complex task, considering the number of available tests and their turnaround time that may delay diagnosis and impact the budget for each patient. At present, most pathogens are detected and identified individually either by culture or PCR-based techniques, and the multiplication of these tests are rarely time (from 48 hours to 7 days) and cost efficient. A real gap exists between the multiplicity of information required by the practitioner and the diagnostic tools available.

Co-financed by the Agence Nationale de la Recherche and the Direction Générale de l’Armement with a total budget of 2,07M€, the TecSan ReSynPlex research project aims at developing an IVD automated high-throughput diagnostic platform allowing multiplexed detection in respiratory samples of bacterial and viral species most frequently involved in hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP). Especially for bacteria, the determination of their main resistance mechanisms to first-line antibiotics will also be integrated.

The consortium is composed of one industrial partner and four academic teams associated to hospital laboratories: