New Liquid, Ready-to-Use Tacrolimus Immunoassay to Help Simplify Therapeutic Drug Monitoring
Thermo Scientific QMS Tacrolimus receives FDA 510(k) clearance.
Thermo Fisher is constantly innovating, delivering new assay methods, calibrators and controls building on its history of product reliability, accuracy, ease-of-use, and lot-to-lot consistency

Dateline:

FREMONT, Calif.
 
Tuesday, July 30, 2013 8:30 am EDT

FREMONT, Calif.--(BUSINESS WIRE)--Transplant physicians working with clinical laboratories must carefully monitor and manage dosages of immunosuppressant drugs—too low, and the patient may reject a transplanted organ; too high, and toxicity problems arise.

To improve monitoring of one of the most commonly prescribed immunosuppressant drugs, tacrolimus, Thermo Fisher Scientific has unveiled the Thermo Scientific QMS Tacroliums Immunoassay, a next-generation test using the company’s most sensitive technology. The liquid, ready-to-use immunoassay kit has recently attained 510(k) clearance from the US Food and Drug Administration for clinical use among kidney, liver and heart transplant patients receiving tacrolimus therapy.

The new immunoassay is on display in booth 5140 during the Clinical Lab Expo at the American Association for Clinical Chemistry (AACC) conference, being held at the George R. Brown Convention Center in Houston from July 30 - August 1.

“Thermo Fisher is constantly innovating, delivering new assay methods, calibrators and controls building on its history of product reliability, accuracy, ease-of-use, and lot-to-lot consistency,” said Marc Tremblay, president, clinical diagnostics, for Thermo Fisher Scientific. In recent years, clinicians have demanded assays with better low-end sensitivity to allow monitoring at the lower dosing levels they have adopted to prevent common drug side-effects, and the QMS Tacrolimus Immunoassay is one outcome of our focus on their evolving needs.”

Based on the Thermo Scientific Quantitative Microsphere Systems (QMS), a homogeneous particle-enhanced turbidimetric technology, the QMS Tacrolimus Reagent kit provides improved low-end sensitivity to aid physicians in monitoring patients on multiple drug therapies.

The liquid, ready to use immunoassay provides bar-coded system reagents to run on the Thermo Scientific Indiko benchtop analyzer. Applications are also available for mainframe, high-throughput chemistry systems. This new product updates the company’s full menu of immunosuppressant immunoassays which includes: cyclosporine, everolimus and mycophenolic acid. Calibrator sets are also available for use with the QMS Tacrolimus Assay. The calibrator kit contains six different calibrators to complete a full six-point calibration, as part of the test procedure.

For more information, please (510) 979-5000, email sales.diagnostics.fmt@thermofisher.com or visit www.thermoscientific.com/diangnostics.

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $13 billion, we have 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit www.thermofisher.com.

 

 

Contact:

Thermo Fisher Scientific Inc.
Kathy Ruzich, 510-879-5157
kathy.ruzich@thermofisher.com