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Development of a High Throughput Assay for Rapid Screening of Congenital Cytomegalovirus Infection using Dried Blood Spots

Award Number: R44DC019890
ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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Development of a High Throughput Assay for Rapid Screening of Congenital Cytomegalovirus Infection using Dried Blood Spots - Project Summary Sensorineural hearing loss (SNHL), a condition where the inner ear cannot convert sound into nerve impulses to the brain, is the most common congenital disease. The leading cause of non-genetic SNHL is congenital cytomegalovirus (cCMV) infection, and the economic burden of SNHL and its detrimental effect on language development in the US is estimated at nearly $4 billion annually. Studies show that prompt antiviral therapy can improve language development in children identified with hearing loss. However, the benefits of early antiviral treatment are highly dependent on rapid diagnosis. If there are no saliva or urine samples available, diagnosis of cCMV infection in children is only possible by examining Dried Blood Spots (DBSs) that are routinely collected at birth. However, current DNA extraction methods exhibit lower sensitivity to detect CMV in DBSs when compared to saliva and urine. Microgen’s One-Step platform, which integrates sample lysis and target amplification, is an innovative, low-cost, and user-friendly technology that can address this challenge. The goal of this project is to develop an inexpensive ($25 each) and rapid (30 min from sample to result) test for diagnosis of cCMV using DBSs, allowing immediate counseling and treatment. Development of Microgen’s One-Step CMV DBS test will provide a new tool for diagnosis, especially in asymptomatic patients with delayed hearing loss.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $944,183 )
2025	2025	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Research Related to Deafness and Communication Disorders	000	4	5/6/2025	NON-COMPETING CONTINUATION	$944,183
														Subtotal = $944,183

Issue Date FY: 2024 ( Subtotal = $998,523 )
2024	2024	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Research Related to Deafness and Communication Disorders	000	3	7/5/2024	NON-COMPETING CONTINUATION	$998,523
														Subtotal = $998,523

Issue Date FY: 2023 ( Subtotal = $1,034,453 )
2023	2023	MICROGEN LLC	903 TEXAS AVE	LA MARQUE	TX	77568	GALVESTON	USA	Research Related to Deafness and Communication Disorders	000	2	6/30/2023	COMPETING CONTINUATION	$1,034,453
														Subtotal = $1,034,453

Grand Total All Awards = $2,977,159

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Development of a High Throughput Assay for Rapid Screening of Congenital Cytomegalovirus Infection using Dried Blood Spots

Award Number: R44DC019890

ORGANIZATION: NATIONAL INSTITUTE ON DEAFNESS AND OTHER COMMUNICATION DISORDERS

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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