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Lab21 Plans to Commercialize CES-1 Gene Variants as PGx Test Kits

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Originally published Aug. 27.

UK-based personalized medicine firm Lab21 will be offering analysis of the CES-1 gene, which has been shown in studies to influence the metabolism of a number of commonly prescribed drugs in people who harbor mutations in this gene.

Lab21 this week said that it has taken a global license from the Medical University of South Carolina's Foundation for Research Development allowing for the detection and analysis of genetic variants of the human carboxylesterase-1 gene.

"This license is a significant milestone for Lab21 as we expand our collaborative reach into the US and this transaction marks the first of a number of technology deals which Lab21 plans to execute in the biomarker and companion diagnostic field," said Lab21 CEO Graham Mullis in a statement.

According to a Lab21 spokesperson, variants in CES-1 have been implicated in the metabolism of the attention deficit hyperactivity disorder drug Ritalin, the influenza treatment Tamiflu, as well as certain antihypertensives, lipid-lowering agents, and oncologics. Additionally, CES-1 also plays a role in the metabolism of illicit drugs such as cocaine and heroin, as well as chemical warfare agents such as Sarin, the spokesperson told Pharmacogenomics Reporter.

"Consequences of the presence of these [CES-1] variants include the inability of the body to properly utilize the drug, potential for unanticipated toxicities, and overall therapeutic failure in treating the targeted disease or disorder," the company said in a statement.

Lab21 is planning to offer CES-1 analysis from its laboratories in Greenville, SC, and Cambridge, UK. Although the company will be initially launching these assays as laboratory-developed tests, it will also be developing commercial diagnostic kits based on CES-1 markers, for which the company plans to seek regulatory approval in the US and abroad.

"First phase will be offering CES-1 mutational analysis from our own reference laboratories," the spokesperson said. "When we have regulatory-approved commercial kits these will be used by a variety of end-users but we envisage that with the current rate of progress in personalized medicine most reference laboratories will be offering pharmacogenetic testing."

Lab21 could not specify the timelines for regulatory submission for these commercial test kits since it is still developing them. Furthermore, although there have been several validation studies published with regard to CES-1 testing in various PGx settings, "we will be undertaking a series of new validation studies with selected clinical partners in the course of the next six to12 months," the spokesperson said.

Financial terms of the deal between Lab21 and MUSC were not disclosed.