Celera licensed its KIF6 discoveries to the University of California, San Francisco (UCSF). The KIF6 gene encodes a kinesin-like protein 6, and published research has shown an association between KIF6 and cardiovascular risk and statin benefit.
UCSF thus becomes the only other laboratory in the U.S. besides Berkeley HeartLab, a Celera subsidiary, to have access to the relevant intellectual property to develop and perform an in-house test for the KIF6 gene variant. Under the terms of the agreement, UCSF will be allowed to develop and perform its own KIF6 test for three years in California. Testing will be performed at UCSF’s pharmacogenomics CLIA-certified laboratory.
“This is consistent with Celera’s strategy to make KIF6 testing broadly available and our efforts to drive our new genetic discoveries into routine personalized care for patients with risk for cardiovascular disease,” reports Kathy Ordoñez, CEO of Celera.
Celera’s diagnostic offerings include the ViroSeq HIV-1 Genotyping System. It has been cleared by the FDA and is CE marked for use in detecting HIV genomic mutations that confer resistance to specific types of antiretroviral drugs. Its Cystic Fibrosis Genotyping Assay is a qualitative in vitro diagnostic device used to genotype a panel of mutations and variants in the cystic fibrosis transmembrane conductance regulator gene in genomic DNA isolated from human whole blood specimens. Cleared by the FDA in 2007, Celera’s CF assay is also CE marked and available worldwide.
Additionally, the AlleleSEQR™ HLA PCR/Sequencing Kits and AlleleSEQR Heterozygous Ambiguity Resolution Primers are used in donor-recipient tissue typing prior to bone marrow transplantation for the treatment of leukemia and lymphoma and donor screening to support stem cell and cord blood registry development. The AlleleSEQR HLA PCR/Sequencing Kits are CE marked but not available in the U.S.
Celera also has multiple diagnostics products in development for the identification and management of various infectious diseases, thrombophilia, liver fibrosis, breast cancer, lung cancer, and fragile-X syndrome. It also has a number of platforms for sample prep and amplification and made-to-order analyte-specific reagents.