Genedx, LLC

Genedx, LLC, doing business as Genedx, is a leading provider of genetic testing and diagnostic services to the federal government, primarily supporting research and clinical programs at the National Institutes of Health (NIH). The company specializes in comprehensive genetic testing, including mutation analysis, exome and genome sequencing, gene panel testing, and mitochondrial testing. Genedx operates from its laboratory facilities in Montgomery Village, Maryland, and has been registered to receive federal awards since May 2008. As a wholly owned subsidiary of Opko Health, Inc., Genedx leverages its expertise in genetic analysis to contribute to various NIH research initiatives and patient care programs.

Through its federal contract awards, Genedx has consistently provided a range of genetic testing services to various NIH institutes, with a particular focus on supporting the NIH Clinical Center and the National Human Genome Research Institute (NHGRI). These services include mutation analysis for patients and families, hereditary myelodysplastic syndromes (MDS) and leukemia panel testing, copy number variation (CNV) testing, exome and genome sequencing, and mitochondrial testing. The contract awards are typically structured as firm fixed-price purchase orders, ranging in value from around $10,000 to $75,000, with performance periods usually spanning several months to a year. The majority of these contracts are awarded without set-aside designations, indicating that Genedx competes in the open market for these specialized services. The company's work directly supports NIH's clinical research missions, providing critical genetic data for various studies and patient care initiatives.

Genedx's involvement in federal grant programs appears to be limited, with only one sub-award identified in the provided information. This sub-award is associated with a grant from Northwestern University for the Channelopathy-Associated Epilepsy Research Center. In this capacity, Genedx contributes de-identified genetic variants discovered through its testing services to support research projects. The company's extensive database of genetic information, derived from panel testing of over 18,000 epilepsy patients and whole exome sequencing of over 86,000 individuals, serves as a valuable resource for prioritizing variants for further study. Genedx's expertise in variant classification is also provided as a resource to the research center, demonstrating the company's role in advancing epilepsy research through collaborative grant-funded projects.

Genedx holds two significant Indefinite Delivery Vehicles (IDVs) with the NIH Clinical Center for mutation analysis services. The first IDV, awarded in June 2021, is a single-award contract with a ceiling value of $1,012,384 and a performance period through June 2024. This contract was set aside for small businesses, indicating Genedx's status as a small business entity at the time of award. The second IDV, awarded in September 2020, has a ceiling value of $250,000 and served as a short-term bridge contract to ensure continuity of critical research and patient care services. Both IDVs enable the NIH Clinical Center to place orders for a wide range of genetic testing services, including mutation analysis, exome sequencing, genome sequencing, and gene panel testing. These vehicles provide a flexible mechanism for the NIH to access Genedx's specialized testing capabilities on an as-needed basis, supporting ongoing research and clinical programs.