3D Signatures Inc. (DXD:CA) announced that it has successfully completed internal analytical assay validation for its Hodgkin’s lymphoma test pursuant to FDA guidelines. Assay validation of Telo-HL included validating the consistency of key reagents and the reproducibility and repeatability of the locked protocol. This process is referred to as Stage 2 of the validation program as set out in the Company’s news release dated February 23, 2017. Assay validation was completed on schedule.
Powered by the Company’s proprietary TeloView™ software platform, Telo-HL stratifies HL patients at the point of diagnosis into non-relapsing and relapsing patients. Relapsing patients may then be considered for alternative treatments at the time of diagnosis rather than waiting until they have failed multiple rounds of standard chemotherapy. There is currently no biomarker available that can predict patient response to standard chemotherapy in HL patients.
The Company expects Telo-HL to benefit patients seeking personalized treatment while also providing significant cost savings to payors and insurers that are currently burdened with expensive treatments and procedures that may not be necessary if patients could be considered for more targeted and effective therapies at the outset.
“The data collected during this validation stage confirms that the Telo-HL assay is reproducible according to FDA guidelines for clinical quantitative assays,” stated Dr. Oumar Samassekou, 3DS’ VP of Clinical Technology. “We are ready and excited to launch the clinical trial to develop and finalize the scoring model for Telo-HL. This will establish a score to delineate relapsing from non-relapsing patients at the time of diagnosis, before they begin first-line chemotherapy.”
The clinical trial will commence in the coming weeks and include the analysis of 250-300 retrospective HL patient samples that match the targeted prognostic criteria for the test. A statistical scoring model will also be developed and finalized from the data collected during the clinical trial. The clinical trial is expected to be complete in less than five months.
3DS (DXD.V) (TDSGF) (3D0.F) is a personalized medicine company with a proprietary software platform based on the three-dimensional analysis of chromosomal signatures. The technology is well developed and supported by 22 clinical studies on over 2,000 patients on 13 different cancers and Alzheimer’s disease. Depending on the desired application, this platform technology can measure the stage of disease, rate of progression of disease, drug efficacy, and drug toxicity. The technology is designed to predict the course of disease and to personalize treatment for the individual patient.
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