Single Source Procurement: New Born Screening Program

The Department of Health (DOH) Wadsworth Center, Division of Genetics has received a contract reporter exemption request approval for a single source purchase from Roche Diagnostics in the amount of $82,581.00; the purpose of which is discussed below:

The Newborn Screening Program is mandated by Public Health Law 2500(a-f) to test and identify all infants born in New York State with serious but treatable neonatal conditions and refer those infants for immediate medical intervention. Failure to complete testing protocols accurately and timely can result in catastrophic health consequences, including infantile death. The Newborn Screening Program tests approximately 270,000 specimens from 240,000 New York infants for 46 congenital conditions each year, reporting over 12 million test results annually. A daily average of over 1,000 specimens must be tested, and results must be reported; delays or stoppages of this required testing will create catastrophic circumstances.

The kit used for the above testing is supplied by Roche Diagnostics the only source for the LightCycler® DNA Master HybProbe kits. All LightCycler® Master Mix Reagents are specifically developed to function in the highly sensitive and proprietary LightCycler® instrument. The LightCycler® instrument, its unique technology and software are proprietary to Roche Diagnostics and have been utilized within the newborn screening program for upwards of nine years. Ultimately, providing successful development, validation, and evaluation for reporting molecular results for newborn screening confirmatory testing. This one time purchase will fill an existing need until a replacement contract can be established.

Procurement / Program Name New Born Screening Program
Contractor Name(s) Roche Diagnostics
Contract Period One Time Purchase
Contract Number(s) N/A