12:54:13 EDT Tue 23 Apr 2024
Enter Symbol
or Name
USA
CA



3D Signatures Inc
Symbol DXD
Shares Issued 46,445,199
Close 2017-02-22 C$ 0.81
Market Cap C$ 37,620,611
Recent Sedar Documents

3D Signatures begins Hodgkin's lymphoma validation test

2017-02-23 12:03 ET - News Release

Mr. Stephen Kilmer reports

3D SIGNATURES INC. INITIATES HODGKIN'S LYMPHOMA VALIDATION PROGRAM

The validation program for 3D Signatures Inc.'s Hodgkin's lymphoma test (Telo-HL) is under way. Telo-HL is powered by the company's proprietary TeloView software platform. The purpose of Telo-HL is to stratify Hodgkin's lymphoma patients at the point of diagnosis into non-relapsing and relapsing patients so that relapsing patients may be considered for alternative treatments to standard chemotherapy at the beginning of their treatment process. There is currently no biomarker available that can predict patient response to standard chemotherapy in Hodgkin's lymphoma patients, and thereby help guide treatment decisions on an individual basis.

"We are truly excited to initiate this program, which we believe will validate the TeloView platform as a disruptive technology based on a universal structural biomarker," commented Jason Flowerday, chief executive officer of 3D Signatures. "Telo-HL has the unique ability to help physicians personalize effective treatments. Once commercially available, we believe this technology will give physicians foresight that is simply unavailable through conventional diagnostic testing."

The Telo-HL validation program consists of five stages which aim to develop a commercially marketable laboratory developed test (LDT) within the next 12 months:

  1. Assay development: This stage included testing different components of the wet lab protocol, imaging protocol and image analysis; optimizing the different variables; and combining the components into a single locked protocol. This stage is complete.
  2. Assay validation: This stage includes validating the consistency of key reagents and the reproducibility of the locked protocol. This stage is in progress and is expected to be completed in the first quarter of 2017.
  3. Clinical trial to develop and finalize the prognostic scoring model: Finalizing the scoring model includes processing 250 to 300 retrospective Hodgkin's lymphoma patient samples that match the targeted prognostic criteria for the test. A statistical scoring model will be developed from the data collected during the clinical trial. The scoring model will establish a positive predictive value, or cut-off, that delineates patients with good outcomes from patients with bad outcomes (relapse versus non-relapse). The company has received the first batch of samples for this stage of the process.
  4. Validation of the scoring model: Validating the scoring model includes processing 70 to 100 retrospective Hodgkin's lymphoma patient samples and analyzing the results according to the scoring model developed in stage 3. This validation stage will seek to confirm that the Telo-HL test results match the clinical outcomes for each of the patients.
  5. Analytical validation by a CAP/CLIA-certified clinical laboratory: A clinical laboratory partner that plans to offer the Telo-HL commercially will conduct this final validation step. This stage includes processing 40 to 60 patient samples in duplicate or triplicate by different operators to confirm the reproducibility of the assay in a certified clinical laboratory setting. Once the clinical laboratory partner has successfully completed its own analytical validation they will have the authority to approve the test as an LDT. The clinical laboratory will then be able to market and offer the test commercially. Subject to deal terms with 3D Signatures' clinical laboratory partner(s), the final validation stage to develop an LDT can be expanded to other clinical laboratories across North America to address the commercial opportunities in multiple jurisdictions.

"There is a very real clinical need for an accurate diagnostic test to predict responsiveness to standard chemotherapy for Hodgkin's lymphoma patients," noted Dr. Hans Knecht, 3D Signatures' adviser, a professor of medicine, and the chief of the division of hematology at McGill University and Jewish General Hospital, Montreal. "Such a test would empower physicians to make treatment decisions on an individual basis."

In addition to better patient outcomes, the company expects that personalized treatment will result in improved health care economics. The estimated cost of treatment in the United States for non-relapsing and relapsing Hodgkin's lymphoma patients is approximately $90,000 (U.S.) and $400,000 (U.S.), respectively. The ability to identify the appropriate treatment for an individual patient at the time of diagnosis should result in expedited use of alternative treatment options and cost savings to the payor.

About 3D Signatures Inc.

3D Signatures 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.

We seek Safe Harbor.

© 2024 Canjex Publishing Ltd. All rights reserved.