A Medical Device Daily
Micronics (Redmond, Washington), a provider of custom lab card design, development, and production services, said it has been awarded a $100,000 Small Business Innovation Research grant to advance its diagnostic test to detect Human Immunodeficiency Virus (HIV) at point of care.
The grant, from the National Institute of Allergy and Infectious Diseases under the National Institutes of Health, will help Micronics determine whether its rapid nucleic acid test to diagnose HIV is comparable in both sensitivity and specificity to the only FDA licensed diagnostic nucleic acid test in use today, the company said.
The project is expected to demonstrate the detection of HIV in a droplet of blood applied to a small disposable cassette that contains all of the required reagents and controls to perform a nucleic acid assay. John Gerdes, PhD, chief scientific officer for Micronics, will serve as the principal investigator under this award.
According to Karen Hedine, president/CEO, the nucleic acid test method requires that a blood sample be taken and sent to a central reference laboratory for analysis, with results provided at a later date. The time lag between sample collection and result means that at-risk individuals might not be readily accessible to the caregiver once test results are known. In addition, she said, the current approach generally requires technical training, expensive, specialized equipment, a reliable power source, and expensive reagents and test kits.
"The overall objective of the NIH grant is to determine whether our test can provide the same kind of information as the current nucleic acid test in use today," Hedine said. "If this can be proven, we believe that our application will offer significant human health benefits, given the fact that it can be performed at reduced cost and in minutes in a doctor's office, public health lab, remote field hospital, or hospital birthing center. It is imperative that cost-effective and highly accurate methods to screen for HIV be developed and proven before such screening can happen at a global level."
"In contrast to the FDA-approved nucleic acid test, another category of commonly used HIV diagnostic tests uses antibodies and may be performed quickly at point of care. However, the current antibody-based tests cannot determine the infectious status of a newborn child for as long as 18 months due to the presence of maternal antibodies," Hedine said. "Because early HIV detection and intervention can have a significant impact on infant survival and overall quality of life, a rapid qualitative molecular test is vital," Hedine added.
In other grants/contracts news:
• Medhost (Addison, Texas), provider of the Emergency Department Information System (EDIS), reported that the University of Virginia Health System (Charlottesville) has chosen Medhost to automate its emergency department (ED). Medhost will be integrated with the hospital's main HIS from GE Healthcare (Waukesha, Wisconsin) and can interface with many other hospital systems to increase patient safety and reduce wait times, Medhost said.
Medhost is a software solutions company that provides process management technology for the healthcare industry.
• Curlin Medical (Huntington Beach, California), a subsidiary of Moog, said it has been awarded a three-year contract to provide its Pain Management-Local Anesthetic Devices and related products to Premier (San Diego), an alliance of not-for-profit hospitals and healthcare systems. The contract includes Curlin AutoMed and Accufuser infusion therapy and pain management devices, consumables, and service agreements. It is the first contract between Curlin and Premier.
Curlin develops solutions for pain management. Moog is a manufacturer of precision control components and systems. Its systems control military and commercial aircraft, satellites and space vehicles, launch vehicles, missiles, automated industrial machinery, marine and medical equipment.
Premier serves 1,700 U.S. hospitals and more than 49,000 other healthcare sites.