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Spartan Bioscience Taps Cardinal Health as US Distributor of CYP2C19 Genotyping Assay

NEW YORK – Spartan Bio said this week that it has tapped Cardinal Health for US distribution of its CYP2C19 genotyping assay for mutations that affect approximately 15 percent of all prescribed drugs. 

Spartan's CYP2C19 assay runs on the US Food and Drug Administration-cleared Spartan RX analyzer, and is indicated for use as an aid to clinicians in determining strategies for therapeutics that are metabolized by the cytochrome P450 2C19 gene product, and specifically affected by the *2, *3, and *17 alleles, according to the company's website. The test uses a buccal swab sample, has a hands-on time of about four minutes with no sample preparation, and returns results in about an hour. 

The new distribution partnership is for the US acute care market where, until now, Ottawa, Ontario-based Spartan was selling directly. Cardinal Health confirmed the distribution agreement, but additional details were not disclosed.

A Spartan spokesperson noted that the company's technology has been used in several landmark clinical studies, the most recently completed being TAILOR-PCI, a 5,300-patient, seven-year study funded by Mayo Foundation and the National Institutes of Health. In April, Mayo Clinic presented results from this trial at the American College of Cardiology late-breaking trial sessions.

In the study, Spartan's FDA-cleared rapid CYP2C19 genotyping test was used to personalize antiplatelet therapy with clopidogrel or ticagrelor. The researchers found that genotype-guided therapy resulted in 34 percent fewer adverse events after 12 months such as death, stroke, second heart attack, and stent thrombosis, which did not meet the study goal of reducing adverse events by 50 percent over 12 months.

However, genotype-guided therapy resulted in 79 percent fewer adverse events in the first three months. "This finding suggests that the lion's share of the benefit of genetically guided therapy may occur during this high-risk period," Naveen Pereira, the study's principal investigator and a professor of medicine and associate professor of pharmacology at Mayo Clinic, noted in a statement provided by Spartan Bio.

"We are excited to partner with Cardinal Health for our precision medicine test," Nick Noreau, Spartan's chief revenue officer, said in a statement. "Cardinal Health touches 90 percent of hospitals in the US and they are a perfect partner to help make Spartan's precision medicine test broadly available to the US acute care market and all US cardiac centers."