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Exonhit’s diagnostic pipeline is currently focused on developing tests for 3 key degenerative diseases:
> Thyroid Cancer
> Infectious Diseases
Thyroid Cancer
The thyroid is an endocrine gland formed of two lobes located at the base of the neck. It secretes the thyroid hormones which intervene in the development of the nervous system, the growth and the level of functioning of many organs.
The thyroid nodules – localized hypertrophies – are very frequent, their prevalence in the general population is 4 to 7% and increases with age. But only 5% of the thyroid nodules are malignant.
8 600 new cases of thyroid cancers are diagnosed each year in France, with an increase of 6% per year these last years. This cancer concerns mainly women, and has good prognosis.
8 600 new cases of thyroid cancers are diagnosed each year in France, with an increase of 6% per year these last years. This cancer concerns mainly women, and has good prognosis.
Diagnosis :
The palpation of the neck is the first examination, the easiest and the most direct one.
Then the TSH blood test and the cervical echography constitute the two basic examinations which allow a first characterization of the nodule.
If the physician judges that following the investigations is useful, the next step is the puncture of cells in a nodule with a fine needle – Fine Needle Aspiration -, followed by a cytologic examination of the sample with microscope. The thyroid cytology is the reference test, but it requires an optimal puncture technique and quality cytology interpretation.
The recommandations of the Bethesda terminology, of which the “Société Française de Cytologie Clinique” published a French version in 2012, allow to standardize the results of the cytology :
The palpation of the neck is the first examination, the easiest and the most direct one.
Then the TSH blood test and the cervical echography constitute the two basic examinations which allow a first characterization of the nodule.
If the physician judges that following the investigations is useful, the next step is the puncture of cells in a nodule with a fine needle – Fine Needle Aspiration -, followed by a cytologic examination of the sample with microscope. The thyroid cytology is the reference test, but it requires an optimal puncture technique and quality cytology interpretation.
The recommandations of the Bethesda terminology, of which the “Société Française de Cytologie Clinique” published a French version in 2012, allow to standardize the results of the cytology :
In this system, 3 categories, which represent around from 15% to 30% of results, square with a uncertain result. In these cases, physicians envisage the partial or total ablation of the thyroid gland.
In 20 to 40% of cases, the histological examination of the surgical piece show that there is no malignancy and so the surgery would be avoidable in 60 to 80% of cases.
In 20 to 40% of cases, the histological examination of the surgical piece show that there is no malignancy and so the surgery would be avoidable in 60 to 80% of cases.
EHT Dx 15 will allow to determine the malignant or benign nature of a FNA sample classified in the “undetermined” results, and then to avoid unnecessary surgeries.
References :
1 Bachelot et al, Médecine Thérapeutique Endocrinologie & Reproduction, Volume 4, Numéro 1, 48-52, Janvier-Février 2002, Diagnostic
2 Recommandations de la Société Française d’endocrinologie pour la prise en charge des nodules thyroïdiens-septembre 2011
3 Cochand-Priollet B, et al.Cytopathologie thyroïdienne : le système de Bethesda 2010. Annales de Pathologie (2012), doi:10.1016/j.annpat.2012.02.015
1 Bachelot et al, Médecine Thérapeutique Endocrinologie & Reproduction, Volume 4, Numéro 1, 48-52, Janvier-Février 2002, Diagnostic
2 Recommandations de la Société Française d’endocrinologie pour la prise en charge des nodules thyroïdiens-septembre 2011
3 Cochand-Priollet B, et al.Cytopathologie thyroïdienne : le système de Bethesda 2010. Annales de Pathologie (2012), doi:10.1016/j.annpat.2012.02.015
Infectious Diseases
- Prosthetic infections
Globally more than 10 million people carry articular prostheses (hip, knee, shoulder). This number is continuously increasing due to an aging population and obesity issues.
In France, the number of people that have a prosthetic joint is estimated at over one million. Approximately 200,000 hip and 50,000 knee prosthetic joints are surgically implanted each year in France, 730,000 hip and 380,000 knee replacements in Europe and more than one million combined prosthetics in the United States. Despite significant progress in recent years, prosthetic joint infections are frequent with rates of 0.3 to 1.8% for hip and 0.5 to 5% for knee prosthetics.
Infections are one of the main complications associated with fitting a prosthetic. They are associated with a very high morbidity rate because they require one or more operations, long-term antibiotic therapy and result in a significant functional handicap.
The traditional methods for detecting prosthetic infections can be misleading. Clinical symptomatology, biological signs of inflammation (CRP, VS) and radiological indications can be variable, sometimes non-specific and delayed. Sample culturing is an invasive procedure, but still remains the reference technique. There are currently no serological tools specifically dedicated to diagnosing and monitoring prosthetic infections.
- Tetanus
In Europe, the incidence of tetanus is estimated at 0,02 case for every 100,000 people and in the US 0,01 case for 100,000 people.
However, tetanus remains a widespread disease. The World Health Organization estimates that 290,000 deaths are caused by tetanus in the world, with most deaths occurring in Africa, South America and Asia. In France, 36 cases were identified in 2011 with a mortality rate of 33% and side-effects rate of 16,7%. Statistics show in France and in the US that the high risk categories are elderly people, women and immigrants.
The prevention of tetanus (the appropriate cleaning of wounds and the injection of immune globulins and/or vaccine) depends on the characteristics of the wound and the vaccination status of the patient. But most patients arrive at emergency care facilities without any vaccination records and without knowing the date of their last booster injection.
ELISA (Enzyme-Linked Immunosorbent Assay) is currently the standard method used for evaluating the immunity status of patients against tetanus. The results are available only after 48 to 72 hours. As a consequence, unplanned prophylaxis is unnecessarily applied in more than 40% of the cases: anti-tetanus immunoglobulin is excessively prescribed in 17 to 30 % of patients presenting wounds favorable to developing a tetanus infection.
The protection against tetanus facilitated by antibodies and can be only obtained by an active vaccination.The anti-tetanus vaccines are prepared from tetanus anatoxin. The efficiency of the tetanus anatoxin to produce a protective response following vaccination is between 80 and 100% in most clinical trials.
Three doses of vaccine during infancy confer a protection lasting 3 to 5 years, an additional booster dose (for example at the beginning of childhood) will provide protect during adolescence and one or two additional boosters will induce an immunity during a substantial part of adulthood – approximately 20 to 30 years.
Diagnosis of tetanus immunization status by medical interview of patients with wounds is poor. The wounds at risk of a tetanus infection are not always easy to identify. Many protected patients receive unnecessary vaccine or immunoglobulin, and unprotected patients may receive nothing.
Tétanos Quick Stick® (TQS) allows the clinician to determine the vaccination status for tetanus of each patient to determine the personalized treatment of that patient with the injections of vaccine or immunoglobulins.
Tétanos Quick Stick® (TQS) allows the clinician to determine the vaccination status for tetanus of each patient to determine the personalized treatment of that patient with the injections of vaccine or immunoglobulins.
Transplantation
“There are approximately 2,000 heart transplantations performed annually in each of the US and European territories, with over 20,000 living heart transplant recipients in both the US and Europe. In Europe, five countries (France, Germany, Italy, Spain, and UK) constitute 70% of these transplants, half of which are conducted in 25 major hospitals1.
Heart transplant recipients need to be routinely monitored for acute cellular rejection. Endomyocardial biopsy has been the standard procedure to accomplish this routine surveillance, although this invasive procedure creates some risk of potentially serious adverse complications and rejection grading may be uncertain due to sampling or reader variability. AlloMap ® represents a major clinical advance in Europe in rejection surveillance.
1. Source : French Biomedicine Agency”