Thermo Fisher Scientific is launching a new test it says can help doctors avoid the “trial-and-error” approach typically used to dose patients with a common anti-rejection drug after organ transplant surgery.
The TacroType Pharmacogenetic Test is a rapid, qPCR-based test that uses a cheek swab or blood sample to identify a patient’s CYP3A5 genotype, which influences how quickly an individual metabolizes the immunosuppressant tacrolimus.
The drug, also sold under the brand name Prograf, helps prevent organ rejection in people who have had a liver, kidney, lung or heart transplant.
Since each patient processes tacrolimus differently—based in part on their genetics—standardizing the dosage is difficult, Thermo Fisher said in a Feb. 26 release. Patients expressing CYP3A5 may require higher starting doses of the drug, according to the company’s website.
Correct dosing of the drug after a transplant is crucial, according to the company, because if the dose is too low, the body may reject the new organ. But, if it’s too high, patients can face serious complications such as infection.
The test can help patients “reach target tacrolimus levels more efficiently and with fewer dose adjustments,” the company said.
“When patients receive a transplant, every day matters,” Tina Liedtky, president of Thermo Fisher’s transplant diagnostics business, said in a statement.
She said the TacroType test “gives clinicians valuable information from the start and supports more effective, personalized care for patients during a critical period.”
The TacroType test is the latest of several test products rolled out by Thermo Fisher in recent months. Last October, the California-based company introduced a test to help physicians better detect and manage lung transplant rejection. A month earlier, it debuted a test that profiles dozens of proteins linked to neurodegenerative diseases.
The company noted the test has not been cleared or approved by the FDA or regulators in the EU as an in vitro diagnostic test.
