Vitalea Science announces grant award for phase-1 development of a diagnostic test utilizing accelerator mass spectrometry and microdosing technologies
Vitalea Science has received a Small Business Innovation Research grant from the NIH, to develop a medical diagnostic test to assess vitamin B12 malabsorption.
The simple test intends to replace the Schillings test, the current standard, for assessing vitamin B12 malabsorption.
The new test will allow physicians to more conveniently diagnose patients with vitamin B12 absorption problems before anemia, dementia and/or other permanent damage develops.
Vitamin B12 deficiency is a significant public health problem, particularly among the elderly.
In the USA, there are 37 million people over age 65.
Conservative estimates indicate that 2-3% of this population has, or will develop, pernicious anemia, caused by failure of gastric intrinsic factor production, resulting in B12 mal-absorption.
Many of these people are unaware that they have the condition, which puts them at risk for developing debilitating fatigue and neurological problems.
The method of 14C labeling of vitamin B12, using a modified strain of salmonella bacteria, was developed by a team of scientists from the University of California, Davis, and Lawrence Livermore National Laboratory including Stephen Dueker, president of Vitalea Science.
The method is protected by a patents filed by the University of California.
The work represents a growing area of clinical research, dubbed 'microdosing', where harmlessly small doses of drug candidates are paired with powerful accelerator mass spectrometry technologies to initially assess bio-activity in humans at very early stages of drug development, in lieu of lengthy preliminary animal testing.
"Sensitive diagnostics have the effect of putting a microscope on specific medical conditions, allowing more accurate and timely intervention as well as better prediction of debilitating medical conditions," Dr Dueker said.
"This B12-diagnostic is the first of what we expect to be many diagnostic tests based on the AMS platform".
"This award symbolises our firm commitment to innovation and our relentless pursuit of Accelerator technology to achieve better tools for disease detection, and safer drugs for people," stated Dr Vuong, chief operating officer of Vitalea Science.
"We plan to have this test carried out on our compact particle accelerator, the bio-Micadas, a joint development with Paul-Scherrer Institut in Zurich.
"We also intend to pursue Phase-II with UCDMC and other clinics to carry out the clinical trials later this year".
Vitalea Science is a technology-driven contract research organisation that provides ultralow detection strategies for drugs and drug candidates at microdose levels.
Situated in northern California, the company was formed by chemists and physicists from the University of California at Davis and the Department of Energy's Lawrence Livermore National Lab in 2003.