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Point-of-Care Nucleic Acid Test for Cytomegalovirus for Newborn Hearing Screening

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 4R44DC012967-02
Agency Tracking Number: R44DC012967
Amount: $1,273,741.00
Phase: Phase II
Program: SBIR
Solicitation Topic Code: NIDCD
Solicitation Number: PA12-088
Solicitation Year: 2013
Award Year: 2013
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
615 Davis Dr., Suite 800 PO Box 14025
United States
DUNS: 140695474
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (919) 287-9010
Business Contact
Phone: (919) 287-9010
Research Institution

DESCRIPTION (provided by applicant): Universal newborn hearing screening is mandated in the US and is performed in the postpartum hospital setting. Current physiology-based hearing screening tests are unable to detect late-onset hearing loss caused by cytomegalovirus (CMV) infection. Therefore, a complementary screening approach has been suggested to prevent disabilities associated with CMV-related hearing loss by early detection and intervention. A nucleic acid test has been described to screen newborns for congenital CMV infection using saliva specimens where it is more sensitive than the dried blood spots traditionally used by the newborn screening laboratories. Newborn screening programs do not have the infrastructure necessary to use newborn saliva samples and molecular assays. Advanced Liquid Logic's digital microfluidic technology is a recognized innovative, low-cost, and automated liquid handling system that can address this challenge. The objective of this Fast-Track application is to develop an integrated lab-on-a-chip to perform screening of congenital CMV infection in newborns using saliva samples. Specific aims in Phase I are to develop protocols for CMV purification from saliva samples and for viral DNA amplification on-cartridge, and to integrate a sample-to-answer CMV screening assay on the digital microfluidic platform. Success in Phase I will result in a Phase II continuation where the specific aims will be (i) to develop a point-of-care newborn screening platform, (ii) to optimize the sample-to-answer CMV protocol in this platform and assess its analytical performance, and (iii) to perform a method comparison with the gold standard rapid saliva culture using neonatal saliva samples in collaboration with the University of Alabama at Birmingham. PUBLIC HEALTH RELEVANCE Newborn hearing screening is performed on almost every baby born in the US but some infants develop hearing loss caused by cytomegalovirus (CMV) infection after the baby passes the current hearing screening test. Therefore, a complementary screening approach has been suggested to prevent CMV-related hearing loss by early detection and intervention. In this project, a digital microfluidic platform will be developed to perform CMV screening at the point-of-care using asaliva sample. Such technology can significantly impact the health outcomes for infants with increased risk of hearing loss caused by congenital CMV infection.

* Information listed above is at the time of submission. *

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