DiagFast : Fast Point of Care syndromic molecular diagnostic

Daniel Gineste posted an update — Apr 25, 2020 01:09 AM EDT

The main reason for the strong spread of Covid-19 contamination is that the first people with symptoms were treated for the flu without being tested. This is particularly the case in France for the evangelical gathering of the Christian Open Door Church in Mulhouse, which brought together 2,000 to 2,500 people from February 17 to 21 and during which more than a thousand people will be contaminated even though several of them presented the symptoms of the disease and consulted several doctors on the spot who diagnosed the flu. It must be recognized that for certain syndromes, the mere experience of a doctor is no longer sufficient to enable him to make a reliable diagnosis without verification by a test procedure. The current solution solicits the biological analysis firms which carry out most of the tests on shared technical platforms with delay of return of the results varying from ½ day to more than 3 days. In addition, these tests are most often mono pathogenic. In a context of pandemic by a new virus, this solution is not suitable. The requirement is diagnostic equipment directly usable by the doctor AND capable of alerting in the presence of an abnormal situation. The only molecular diagnostic solution suitable for this situation is a DNA biochip capable of producing an immediate diagnosis on all pathogens related to a syndrome through the hybridization analysis of a few hundred probes. The analysis of the result of the hybridization of the probes of a biochip can have 3 types of responses: • The result corresponds to one or more pathogens: the attending physician can then immediately issue the prescription and treatment adapted to his patient; • The active result of probes representative of a family of pathogen, without activating the known specific ones: It is possible that we are in the presence of a mutation or a new pathogen in a known family (influenza, coronavirus,… ); • No probe other than the test ones has been hybridized. The patient has an unknown pathology: Check with a biochip of a similar syndrome. In the latter 2 cases, it is either the severity of the patient's case, or the recurrence of this type of result that will trigger the alert and implement a sequencing process on the samples concerned.

The DiagFast project, stemming from the expertise of the start-up Dendris in the production of syndromic DNA biochips, proposes to respond to this need with diagnostic equipment available from the general practitioner, emergency services, nursing homes and even in the sampling points of the analysis laboratories for a result in less than 45 minutes.

The solution is based on a method of depositing the probes in the form of a nanometric network and on measuring the diffraction intensity of a light ray before and after hybridization of the probes. An international patent has been filed. The work carried out as part of a thesis demonstrated the extreme sensitivity of the device to the detection of hybridization and comforted scientists in the possibility of carrying out a molecular diagnosis without PCR or labeling. The creation of DiagFast aims to resume this work to design a small-scale multiplex in vitro molecular diagnostic equipment, of the Point of Care type, fully automated from the sample. He should be able to process 1 to 8 samples simultaneously and perform syndromic molecular diagnostics on a few dozen pathogens in just 45 minutes. The solution will use Dendris’s cloud-based Artificial Intelligence system, which automatically produces the diagnosis but also anonymizes all test results from all equipment. A permanent scan of all the profiles makes it possible to identify repeated and unidentified signals, to request the collection of extracts from the original sample in order to sequence them to identify any new infectious agent, or the start of an epidemic if geographic data is associated. The DiagFast project brings together an economic diagnostic tool and an epidemiology tool capable of constantly and real-time monitoring of the emergence of known or unknown conventional infectious agents. The DiagFast biochip would give doctors, epidemiologists and political authorities the edge that can drastically reduce the economic and human cost of mass containment. The first step is to recruit a small operational team to resume the experiment in partnership with 2 public research laboratories in Toulouse: Toulouse Biotechnologie-Insa and LAAS-CNRS. Once the scientific objectives are specified and validated, we will be able to find private funds and industrial partners to carry out this project and commercialize it. The scientists behind the patents and processes undertake to coach the operational staff of DiagFast. This project represents an effective territorial vigilance solution and at almost zero marginal cost in addition to the funding of routine tests. It quickly alerts health authorities and helps to easily identify clusters. The systematic use of a syndromic biochip test makes it possible to correctly refer patients and isolate suspected cases, even without having probes specific to the new pathogen.

Daniel Gineste started this project — Apr 24, 2020 06:55 PM EDT

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