Roche Sees Tests Flagging Drug Risks, Cutting Costs

Roche Diagnostics chief Heino von Prondzynski believes tiny glass chips that detect the risk of dangerous drug reactions are the first in a new generation of tests that will revolutionize the practice of medicine and help reduce healthcare costs.

The unit of Swiss healthcare firm Roche Holding AG last month got U.S. regulatory approval for the AmpliChip CYP450, a tiny glass chip that analyzes two genes that govern how patients metabolize drugs. Von Prondzynski in an interview on Thursday said Roche will launch the AmpliChip in the United States in March. “It’s the first in a number of chips that we are going to launch over the next couple of years,” he said. The tests are part of Roche Diagnostics’ push to exceed market growth, which Von Prondzynski projects at 4 to 6 percent in 2005. “I don’t expect miracles,” he said. He’s looking to exceed market growth by more than half a percentage point. The AmpliChip is part of a new class of diagnostic tools called microarrays, the same type of tools molecular biologists have used to discover promising drug compounds. Frequently called “molecular microscopes,” the tests use patients’ genetic information to measure the rate of their metabolism, which can help doctors make better decisions about which medications to select and what doses to prescribe. Von Prondzynski, who is in the United States following the release of Roche’s financial results on Wednesday, said the tests will reduce healthcare costs and improve drug safety. Currently, adverse drug reactions cost $4 billion each year. Von Prondzynski believes testing with the AmpliChip 450 could shave off nearly $1 billion of those costs. He said Roche is in talks with Medicare officials and private insurance companies to gain reimbursement for the test, which will cost about $400. “The feedback we’re getting from HMOs sounds very positive,” he said. Von Prondzynski projects peak sales of $100 million, with nearly half of that coming from the United States. Roche said its AmpliChip Leukemia test will become available for use at research facilities in the fourth quarter of 2005, and may receive European regulatory approval by the end of 2006. The AmpliChip-based tests are made using microarray technology by Affymetrix Inc. . Roche is also working on chips testing for various forms of cancer. Roche, the world’s leading diagnostic company, also is No. 1 in the United States. In the diabetes sector, Roche is second to Johnson & Johnson in the United States. In 2004, J&J grabbed half a percentage point of market share, Von Prondzynski said. “J&J is a formidable competitor,” he said. He said the company is ready for the U.S. Food and Drug Administration to reinspect the insulin-pump manufacturing facilities it acquired from Disetronic in 2003. The agency issued a letter in 2003 citing certain deficiencies in manufacturing processes and documentation at the plant in Burgdorf, Switzerland. When reopened, Roche will take steps to launch its next-generation insulin pump in the United States. “We are ready for the inspection. We’ve done our homework,” he said.(Source: Reuters Health, February 2005)