Clinical OMICS

MAR-APR 2019

Healthcare magazine for research scientists, labs, pathologists, hospitals, cancer centers, physicians and biopharma companies providing news articles, expert interviews and videos about molecular diagnostics in precision medicine

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Page 19 of 51

18 Clinical OMICs March/April 2019 Big Data in Clinical Pharmacogenomics I t can be useful to think of drugs as cruising down a multi-lane highway being metabolized en route to their departure from the body. "Drugs are very specific as to the lanes they drive on for leaving the body." said Kristine Ashcraft, CEO of YouScript. If a per- son is taking multiple medications, some lanes may be blocked or simply occupied by other drugs. In addition, depending on an individual's genetic makeup, some lanes might be plenti- ful or—the opposite—not exist at all. These extremes can mean that the standard dose of a drug will be an overdose for some people and completely ineffective for others. And it turns out that genetic wide-open highways as well as lane closures are remarkably common. When it comes to how drugs interact with human genetics, "it's rare to be normal," said Ashcraft. "The recommendations we make for drugs and dosing are based on an average human who doesn't exist." So who should be offered pharmacogenomic (PGx) test- ing (typically a 22-gene panel)? And how are clinicians and pharmacists supposed to understand all of the possible drug–drug and drug–gene interactions implicated by such panels? One company offering a solution is You- Script. Their clinical deci- sion support tool is built from a knowledgebase of drug–drug, drug–gene, and drug-drug–gene inter- actions. And it generates a single actionable guidance based on the cumulative effect of a patient's PGx test results and entire drug regimen. This is something unique to YouScript: the abil- ity to draw conclusions across multiple genetic factors and multiple medications. Other companies offering pharma- cogenomic decision support identify specific pharmacog- enomic interactions, but don't generate a single guidance for a complex genetic or polypharmacy situation. But YouScript has set its sights on using PGx big data in other ways as well. The company recently patented a "Phar- macogenomic Risk Score," which they calculate by plugging a patient's list of medications (including over-the-counter and herbals) into a deep database that contains not only drug–drug, drug–gene, and drug–drug–gene interactions but also PGx allele frequencies in the population. The score tells a pharmacist or clinician the specific percentage chance that ordering a PGx panel will lead to an evidence-based YouScript recommendation to change at least one drug or dose in a patient's regimen. YouScript validated the risk score against several hundred thousand patients who were 65 years of age or older and taking at least three medica- tions. "As genetic risk increased, so did the likelihood of an emergency room visit or hospital stay," Ashcraft said. More- over, ordering PGx testing on patients with heightened risk and providing guidance based on the results reduced these same events in several published studies. YouScript is also integrating data from about half a million patients' PGx panel tests with real-world clinical data from EHRs to enhance its pharmacogenomics decision support tool for clinicians and pharmacists. The system is very data driven, tracking emergency room visits, hospitalizations, adverse drug events, changes to drugs, and even interaction flags not acted upon. "The more systems putting that data in there, the more we are going to be able to get good at drawing conclusions for complex variables," Ashcraft said. Once YouScript PGx test results are present in a patient's record, any newly prescribed medication can result in an alert. "We would interrupt before the prescription is issued to say 'due to a significant interaction, we recommend you select a different drug or dose for this patient,'" Ashcraft said. The clinician or pharmacist can click on the warning to enter the YouScript interface where they can select alter- native medications at the click of a button. "I think we're headed to a place where everyone has this in their medical record," Ashcraft said. —Katharine Miller Kristine Ashcraft, CEO, YouScript LeoWolfert / iStock/ Getty Images

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