Tétanos Quick Stick® (TQS):
Tétanos Quick Stick® (TQS) is able to provide a reliable and rapid assessment, in emergency clinics, to assist in the decision of which personalized anti-tetanus prophylaxis is appropriate.
Tétanos Quick Stick® (TQS) is a unitary test that allows, within 10 minutes, the determination of the tetanus vaccination status of a patient with an at risk wound. Using TQS avoids hyper-immunization and limits the administration of unnecessary immunoglobulin injections.
In-house development products
BJI InoPlex® is the first multiplex serological test to aid in the diagnosis of Prosthetic Joint Infections (PJI). The test uses a panel of pathogen-specific recombinant antigens derived from the most frequent microorganisms causing PJI: Staph. epidermidis, Staph. aureus, Staph. lugdunensis, Streptococci Group B and Propionibacterium acnes.
Developed on both Luminex® 100/200™ and MagPix®, BJI InoPlex® is a test to help in a differential diagnosis between mechanical failure of the prosthesis and a potential infection. The test is intended to be used in case of suspiscion of PJI in addition of the usual diagnostic tool.
Deriving strength from its expertise acquired through the development of Dx14, Diaxonhit decided to develop a new signature for the diagnostic of thyroid cancer: Dx15.
The thyroid nodules are frequent - prevalence of 4 to 7 % (1) in the general population -, but only 5% of them are malignant (2). The reference test for the diagnostic of thyroid cancer is the thyroid FNA followed by a cytological examination with microscope.
The Bethesda classification recommendations, of which the French Society of Clinical Cytology published a French version in 2012(3), allow the standardization of cytology results:
In this system, 3 categories, which represent from 15% to 30% of all results, end with an uncertain diagnosis. In these cases, physicians regularly procede with the partial or total ablation of the thyroid gland.
Dx15 will determine the malignant or benign nature of a FNA sample classified as “undetermined” by the current clinical assessment guidelines, and ultimately avoid unnecessary surgeries.
Exclusive license products
AlloMap® is a gene-expression profiling based blood test. The test is a new method for regular and non-invasive surveillance of heart transplant recipients for acute cellular rejection, thereby contributing to patient follow-up optimization. AlloMap provides unique information regarding the body’s immune response to a transplanted heart in the form of an objective score.
The test has been clinically validated in four major clinical studies in the US and Europe, involving over 2,000 heart transplant recipients and 40 clinical centers. Surveillance of heart recipients with the non-invasive AlloMap test has been shown to be as effective as surveillance with biopsies in heart transplantation clinical outcomes, based on the landmark IMAGE study published in the New England Journal of Medicine in April 2010.
The International Society of Heart and Lung Transplantation recommended AlloMap testing in its guidelines for the management of heart transplant recipients in August 2010.
Developed and marketed since 2005 by XDx in the United States as a CLIA certified test, AlloMap was cleared in 2008 by the U.S. Food and Drug Administration through the 510K de novo process, and has gained acceptance by heart transplantation key opinion leaders to aid in the management of their patients as an alternative surveillance method. 2,000 heart transplants are performed annually in the United States in 120 medical centers, and over 90 centers have used AlloMap. To date, more than 10,000 patients have received the test in the United States. The use of AlloMap has extensive reimbursement coverage by both private and government health insurance. The test received CE marking in 2011.
Diaxonhit will promote AlloMap in Europe through its wholly owned subsidiary, InGen, the leader in France for marketing tests related to transplantation and histocompatibility testing.
Co-developped with Partners products
Headed by project leader ERYTECH Pharma, the consortium includes Diaxonhit, AP-HP (Paris Public Hospitals), Inserm (National Institute for medical research), and Paris-Diderot University. It aims at developing innovative therapies for the enzymatic treatment of chemo- or radio- resistant cancers, and tools enabling personalized care of patients.
Companion diagnostic for resistant cancers
Diaxonhit will be responsible for two phases of the project that utilize its hGWSA technology, which enables the study of the transcriptomic profile of tumors:
1) the identification of biomarkers of susceptibility to therapeutic response in the context of reducing the risks associated with the development of treatments, and
2) the development of an enzymatic therapy companion diagnostic that will identify responders, thus improving personalized care.
Test for treatment monitoring
Diaxonhit is also in charge of the development of a test to monitor the direct effect of drug activity by measuring the depletion of amino acids. The test result will allow the clinician to adjust and optimize an individual patient’s therapeutic regiment.