Qiagen wins FDA OK for organ transplant test

Qiagen CEO Peer Schatz

Qiagen ($QGEN) received FDA approval on June 24 under a full PMA for an assay that monitors the viral load of cytomegalovirus (CMV), a common virus that can be fatal to weakened immune systems, in organ transplant patients.

The company's artus CMV RGQ MDx Kit is the only PCR-based assay the FDA has so far approved optimized for the low- to mid-throughput testing of the virus. The test provides results in three to four hours, and utilizes an earlier Qiagen diagnostic test approved by the agency in 2012 for MRSA.

"In addition to helping save lives with its clinically proven usefulness, the FDA-approved artus test creates economic value by reducing the time and money many labs and hospitals currently must spend validating lab-developed CMV tests and analyte-specific reagents," Qiagen CEO Peer M. Schatz said in a statement.

More than one million CMV tests are performed on U.S. transplant patients each year. Testing is mostly used to help with the management of solid organ transplant patients to determine whether the viral load is responsive to therapy. Between 20% and 60% of total transplant patients in the U.S. are repeatedly tested throughout the first year following an organ transplant.

Qiagen joined forces with Eli Lilly ($LLY) last month to create modular assay panels, specifically to test DNA and RNA at the same time. The Netherlands-based holdings company also has more than 20 co-development and co-commercialization projects underway. The FDA last month approved Qiagen's Therascreen companion diagnostic test to help identify patients with metastatic colorectal cancer associated with KRAS mutations: found in about 40% of patients.

The company reported adjusted net income of $53.7 million in its first quarter, with net sales increasing 4.5% year over year. The molecular diagnostics unit accounts for nearly half of all sales and grew 1%.

- here's the release