GeneSight employs a proprietary algorithm to analyze 12 genes and assess how they impact patients’ ability to process dozens of psychotropic medications. The test report buckets depression treatments as red (significant gene-drug interaction), yellow (moderate gene-drug interaction), or green (use as directed.) When the test report shows that patients are on red or yellow medications, their doctors should consider changing the drug or dose, while patients on green medications don’t require a medication change.
Researchers further evaluated patients who entered the study on red medications and either remained on red medications or were switched to yellow or green drugs. Remission rates were 153 percent higher, response rates were 71 percent higher, and symptom improvement rates were 59 percent higher when patients were switched from red to yellow or green meds — all statistically significant changes.
This analysis “establishes a new standard of care” for physicians by demonstrating that patients on red medications must be identified and have their medications modified, said Dechairo. “This switching analysis has also been an important point in our payor discussions, as utilization management programs can focus on switching patients from red medications, which would deliver results even better than those in the GUIDED study,” he said.
One prior cost-effectiveness study using drug claims data showed that using GeneSight can increase treatment adherence and save an average of $1,036 per year per patient, while another study using commercial claims data showed GeneSight’s potential to save $1,556 per patient by reducing disability claims, medical utilization, workplace absence.
Currently, the more than 300,000 GeneSight tests Myriad sells per year are largely ordered by psychiatrists. Once there is greater reimbursement traction, Myriad is planning a significant marketing push into the primary care market, including direct-to-patient advertising for the test, according to Capone.
GeneSight, which is a lab-developed test (LDT) performed in a CLIA-certified lab, must be ordered by physicians.
Capone noted that the FDA has publicly stated that it will continue to practice enforcement discretion for LDTs, and leave it up to legislators to reform diagnostic regulations that may or may not bring LDTs under the agency’s oversight. In December, legislators in the House of Representatives and the Senate incorporated the FDA’s ideas for diagnostics regulatory reform into a draft bill that features a pre-certification program that labs could use to bring the majority of new diagnostics to market, while having to submit around 10 percent of tests for premarket review. READ MORE…