Lab-on-a-Chip for Multiplexed Newborn Screening of Lysosomal Storage Disorders

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$1,056,545.00
Award Year:
2009
Program:
SBIR
Phase:
Phase II
Contract:
2R44HD057713-02
Agency Tracking Number:
HD057713
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
ADVANCED LIQUID LOGIC
ADVANCED LIQUID LOGIC, 615 Davis Dr., Suite 800, RESEARCH TRIANGLE PARK, NC, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
140695474
Principal Investigator:
VAMSEE PAMULA
(919) 287-9010
VKP@LIQUID-LOGIC.COM
Business Contact:
RICHARD WEST
() -
information@liquid-logic.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Newborn screening is currently performed by collecting dried bloodspots from infants and then sending them to a lab for analysis. Lysosomal storage diseases alone number greater than 40 and there is an increasing necess ity to screen for a number of disease conditions for which therapies are becoming available. Tandem mass spectrometry is an excellent multiplex detection technology widely utilized in newborn screening, but when applied to enzyme assays it is very expensiv e, time consuming, labor intensive, and more importantly the multiplexing power of mass spectrometry is not leveraged because each assay has to be performed individually. There is a need for an inexpensive, rapid, automated, and scalable technology for per forming newborn screening assays that a mass spectrometer is not well-suited to perform. A digital microfluidic system for performing enzymatic assays in newborn screening will enable walkaway automation and multiplex several assays very inexpensively. Bas ed on Advanced Liquid Logic's successful demonstration of digital microfluidic manipulation of nanoliter-sized droplets of enzymatic reagents and sample for dispensing from on-chip reservoirs, high speed transport, mixing, splitting and dilution, and absor bance, fluorescence, and luminescence detection of the assays, a disposable lab-on-a- chip will be developed. In phase I, we have successfully demonstrated a multiplex fluorescence enzymatic assay on a digital microfluidic cartridge to setup screening for Pompe, Fabry, and Hurler disorders on dried blood spot samples. Phase II work will focus on increasing the throughput of the cartridge to screen for 6 lysosomal storage disorders for which therapies exist including Pompe, Fabry, Hurler, Hunter, Gaucher, an d Maroteaux-Lamy, on 96 dried blood spot samples yielding a total of 576 enzymatic assays on a single cartridge. Also, a pilot screening study will be performed in collaboration with Duke University and North Carolina State Lab of Public Health, which woul d involve screening about 10,000 dried blood spots on the digital microfluidic platform. PUBLIC HEALTH RELEVANCE: Newborn screening is performed on every infant born in the US and there is a growing interest in increasing the number of conditions screened for. In this project, a digital microfluidic platform will be developed to screen for many treatable conditions simultaneously using much lesser volume of blood from an infant. It would be greatly useful in identifying treatable diseases earlier.

* information listed above is at the time of submission.

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