The U.S.Food and Drug Administration has approved a DNA test to ascertain how transplant patients respond to treatment for cytomegalovirus or CMV, according to an FDA statement, to improve post-surgery recovery.
The COBAS AmpliPrep / COBAS TaqMan CMV Test, developed by Swiss pharmaceutical firm Roche’s molecular diagnostics division in Somerville, New Jersey, determines the amount of CMV nucleic acid present in a sample of a patient’s blood plasma.
CMV is a common virus that can cause severe diseases such as pneumonia or colitis in people with weakened immune systems, including solid organ transplant patients. Solid organ transplants include heart, lung, pancreas, kidney, or small intestine transplants, according to an FDA statement.
The DNA test is believed to be more precise than existing lab tests to measure CMV treatment effectiveness.
“Laboratory developed tests for measurement of CMV viral load abound, but likely there is clinically significant variation between these assays. The availability of a quality-systems developed test that has been analytically validated against an accepted international standard is a significant potential benefit to clinical laboratories and indirectly to physicians and patients,” according to an e-mailed statement from the FDA.
Last year there were 28,538 solid organ transplants, according to U.S. Health Resources and Services Administration’s Organ Procurement and Transplantation Network.
Earlier this week, Roche got FDA approval for a dual-target HIV test to help measure the viral load or severity of infection. The test focuses on “two highly conserved regions of the HIV-1 genome.” It does not include regions which are current drug targets, according to a company statement.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Last month, Roche said it would close its Nutley, New Jersey site by 2015 as part of an effort to consolidate its R&D activity in Switzerland and Germany. It plans to keep about 400 jobs in New Jersey, according to a company statement.
