Bio-Rad Laboratories VARIANT™ Newborn Screening Systems (VNBS) and Test Kits

The Florida Department of Health's Bureau of Public Health Laboratories (BPHL) has a need to purchase FDA-approved Sickle Cell test kits, which includes the use of seven VARIANT Newborn Screening Systems through a reagent rental agreement. The system and reagent test kits will be used to screen newborns for hemoglobinopathies, such as sickle cell, which is a required test in Florida's approved newborn screening panel, per Chapter 383.14, Florida Statutes. This single-source procurement from Bio-Rad Laboratories, Inc. is for a 3-year term and has an estimated dollar value of $1,276,020.00. Responses from prospective vendors are due by 4/26/2022. Bio-Rad Laboratories, Inc. is the sole distributor and manufacturer of the VARIANT Newborn Screening System and reagents, which are the only FDA-approved system for screening newborns for hemoglobinopathies using dried blood spots.

The procurement is limited to Bio-Rad Laboratories, Inc. as the sole source, as they are the exclusive distributor and manufacturer of the required VARIANT Newborn Screening System and reagents. There are no set-aside designations or restrictions on the types of organizations that can respond. The current incumbent is Bio-Rad Laboratories, Inc., and the procurement will require integration with their existing technology. The estimated budget range for this contract is $1,276,020.00.