There’s a better way to understand how heart transplant patients respond to therapy.

After surgery, heart transplant patients are prone to any number of conditions related to the procedure, specifically the body’s immune response to a new heart. To better understand the effectiveness of treatments and therapies after surgery, clinicians test for cytomegalovirus (CMV), used to assess the viral load. To provide a faster, more accurate way to assess the CMV load in patients, Roche announced that the FDA has approved its cobas^® 6800 and 8800 Systems, via the first World Health Organization (WHO) International Standard to improve the international “harmonization” of CMV testing among hospitals and healthcare providers.

Gathering accurate, actionable data from any testing regime requires standardization, repeatability and efficiency. According to Roche, its fully automated cobas Systems offer the “fastest time to results” as well as high throughput, and what it characterizes as the “longest walk-away time” among automated molecular platforms. Roche also noted that in addition to the platform’s CMV assay, the FDA has approved its cobas Systems to conduct viral load tests for HIV-1, HCV and HBV.

Uwe Oberlaender, head of Roche Molecular Diagnostics, said "With this second generation test, clinicians can now receive faster, more reliable, standardized results aligned across institutions. This is a required and important step towards optimizing CMV management decisions for transplant patients."

Roche explained CMV is the most serious and common infection to afflict heart transplant patients. The virus is easily transmittable through the donor organ and can be reactivated in the recipient. “CMV disease in hematopoietic transplant recipients,” said Roche, “can cause life-threatening damage to many organs including the lung, liver, kidney, gastrointestinal tract and eye. Between 50 and 80 percent of the adult population in the U.S. are infected with CMV.”

Employing a real-time polymerase chain reaction (PCR) test, the system, said Roche, offers an expanded range (from 34.5 IU/mL to 1E+07 IU/mL) with “robust” coverage of genotypes. The company explained the testing system minimizes variability and complexity and offers clinicians an alternative lab developed tests. Roche said this reduces workload in the lab and reduces risk because of its high-quality data, standardization and reproducibility.