DxTerity Diagnostics Receives CE Mark for the REDI-Dx(R) Radiation Biodosimetry Test

Food and Healthcare Press Releases Wednesday May 30, 2018 08:58
LOS ANGELES--30 May--PRNewswire/InfoQuest
REDI-Dx(R) blood test to estimate absorbed radiation after a nuclear event

DxTerity Diagnostics has declared conformity with the requirements of the European In Vitro Diagnostic Directive (98/79/EC) and has applied the CE mark to the REDI-Dx(R) Radiation Biodosimetry Test for the quantitative estimation of the absorbed ionizing radiation dose after a nuclear event.

A radiological event, from the use of a nuclear weapon or improvised nuclear device, could potentially expose thousands of individuals to high or moderate levels of radiation that would require immediate medical intervention. REDI-Dx measures the biological response to radiation and provides individualized estimates of absorbed radiation from a peripheral blood sample. Physicians can use the estimate, in conjunction with radiation dispersal monitoring and clinical signs and symptoms, to prioritize the highly and moderately exposed individuals from the concerned public for medical treatment.

According to Bob Terbrueggen, CEO and Founder of DxTerity, "REDI-Dx fulfills a critical unmet need for responding to a mass scale nuclear event. It is the first CE-IVD assay for radiation biodosimetry and is designed to integrate into existing clinical testing infrastructure and read-out on the installed base of ABI 3500 Dx CE instruments."

The dicentric chromosome assay is the current "gold standard" in Europe and Asia; however, the limited testing capacity, lack of standardization, and 72-hour time to result limits its practicality. REDI-Dx overcomes these limitations with ambient sample shipping, 6-hour assay processing time, and a standardized CE-IVD kit for high throughput testing.

REDI-Dx is the result of a multi-year collaboration between DxTerity, Duke University, the University of Arizona, and Thermo Fisher Scientific; as well as patients and researchers from City of Hope Cancer Center and University of California Los Angeles. This project has been funded in whole or in part with Federal funds from BARDA under Contract No: HHSO100201000001C and Contract No: HHSO100201600034C.

About REDI-Dx(R):

The REDI-Dx(R) Biodosimetry Test is designed to measure a panel of gene expression markers and estimate individualized levels of absorbed ionizing radiation from a blood sample after a nuclear event. www.REDIDx.com .

About DxTerity:
DxTerity provides services and technologies to partner organizations, such as molecular diagnostic test development and end-to-end management of population-scale genomic studies. www.DxTerity.com .

Latest Press Release

Walgreens Boots Alliance and Microsoft establish strategic partnership to transform health care delivery

- Companies aim to improve health outcomes and lower overall costs with enhanced digital and retail experiences and an R&D commitment to build health care solutions through seven-year agreement Walgreens Boots Alliance Inc. (WBA) and Microsoft Corp....

Ascensia Diabetes Care Announces Global Partnership With POCTech to Distribute and Co-develop Continuous Glucose Monitoring Systems

Ascensia Diabetes Care today announced it has entered into a global alliance with Zhejiang POCTech, Co., Ltd (POCTech), a developer and manufacturer of continuous glucose monitoring (CGM) systems. (Logo:...

MGI Announces Milestone of 1,000 Sequencers Installed and Opens Early Access Program for Groundbreaking Ultra-High-Throughput Sequencer, MGISEQ-T7

MGI, established in 2016 as a subsidiary of global genomics leader BGI Group, announced it has reached a new milestone of 1,000 MGI sequencers installed in 16 countries. MGI Chief Operating Officer Dr. Hui Jiang also announced the availability of MGI's...

Gift of Life Donor Program is U.S. Leader in Saving Lives

For the 11th consecutive year, Gift of Life Donor Program is the nation's leading organ procurement organization (OPO), coordinating the most life-saving organs for transplant among all 58 U.S. OPOs. Gift of Life broke two national records in 2018,...

Helsinn Group Grants Exclusive Licensing Rights to Menarini for Pracinostat

Licensing rights are worldwide excluding US, Canada, Japan and South AmericaHelsinn, a Swiss pharmaceutical group focused on building quality cancer care products, and Menarini, an Italian biopharmaceutical Group active in 136 countries worldwide, today...

Related Topics