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

Venus Medtech Enters North American Market

- First Clinical Implantation of Transcatheter Pulmonary Valve VenusP-Valve in North America was Successfully Performed in Vancouver, Canada On June 12, 2018, St Paul 's Hospital in Vancouver, Canada successfully completed two cases of VenusP-Valve...

What You Think About Getting Old Impacts Your Health, Quality of Life According to New Orb Media Reporting

New Orb Media Inc. reporting and data analysis [ https://www.orbmedia.org/agewell ] shows a strong connection between how we view old age, how well we age and the effects seen across world cultures. Individuals with a positive attitude towards old age...

Johnson Johnson Announces Acceptance of Binding Offer From Platinum Equity To Acquire LifeScan, Inc.

Johnson & Johnson (NYSE: JNJ) today announced that it has accepted the binding offer from Platinum Equity, previously announced on March 16, 2018, to acquire its LifeScan business for approximately $2.1 billion. LifeScan, Inc. is a world leader in...

KTC in association with Bangkok Hospital give a talk on Minimally Invasive Surgery and offer a package of Ovarian and Uterine Cancer Screening.

"KTC" or Krungthai Card Public Company Limited by Ms. Sireerat Corvanich, Vice President - Credit Card Business, sees the importance of health care for women especially with pelvic examination, therefore in association with Women Health Center of Bangkok...

Joint Commission International Appoints New Leadership in Key Strategic Region

Joint Commission International (JCI) is pleased to announce John Yoon, MBA , as JCI's managing director of the Asia-Pacific Region. In this role, he is responsible for developing relationships between JCI and health care organizations, governments,...

Related Topics