3D Signatures announced the completion of the assay validation of its Hodgkin’s lymphoma (HL) test, called Telo-HL, required under guidelines from the U.S. Food and Drug Administration (FDA).
Telo-HL is powered by the company’s proprietary TeloView diagnostic technology platform that analyzes changes in telomere structures within DNA to determine aspects and characteristics of deadly diseases like HL.
Telomeres are structures found at the ends of human chromosomes that work much like the plastic tips on shoelaces. 3D Signatures is the first and only company to understand and quantify normal vs. disease telomere arrangement, turning this into usable, reliable, and highly valuable information that can improve patient outcomes.
The internal analytic assay validation of Telo-HL, the stage 2 in 3D Signatures’ validation program, included a validation of the consistency of key reagents, as well as the reproducibility and repeatability of the locked protocol.
The purpose of Telo-HL is to stratify HL patients into non-relapsing and relapsing patients, so that relapsing patients may have the option for other therapies besides standard chemotherapy at the start of their treatment.
There is currently no biomarker available that can predict patient response to standard chemotherapy among these patients or helps guide treatment decisions on an individual basis.
3D Signatures hopes that the new validation assay can help patients with Hodgkin’s lymphoma who are seeking tailored therapies. In addition, the company hopes that Telo-HL will provide significant cost savings to payers and insurers who are paying for expensive treatments that may be unnecessary if patients are eligible for targeted and effective therapies.
The clinical trial is expected to begin within coming weeks, and will analyze 250 to 300 retrospective samples from Hodgkin’s lymphoma patients matching the targeted prognostic criteria for the test. The researchers will also develop a statistical scoring model from the data gathered during this study. According to the company, the study should be completed in less than five months.
“The data collected during this validation stage confirms that the Telo-HL assay is reproducible according to FDA guidelines for clinical quantitative assays,” Oumar Samassekou, 3D Signatures’ vice president of clinical technology, said in a press release.
“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,” he said.