For laboratories interested in creating a molecular service, “training is an enormous problem,” Dr. Frederick Kiechle says. In Michigan, medical technology schools were in the vicinity of the William Beaumont Hospital, and the hospital was able to set up a loan system for technologists to intern with Beaumont’s molecular diagnostics program.
Medical technology students who did their internship at Beaumont rotated through the molecular diagnostics lab. The interns were paid a stipend but given a loan to cover their living expenses for the internship period. That loan was forgiven if the student then went on to work at Beaumont for several years after completing his or her training, Dr. Kiechle says.
But in south Florida, where Dr. Kiechle works now, no training programs are available. “So we’re currently suffering from the general shortage of trained medical technologists, and we also have licensing issues to ensure the appropriate background.”
“There are very few molecular training programs out there—only about six for molecular pathology and just a couple for molecular technology,” Dr. Dan Hyder notes. So Dr. Hyder actually took two technologists from the core laboratory and paid for them to take a graduate-level training course online through Michigan State University, after which they passed an exam to become certified molecular technologists.
“I don’t know how the country will respond, but we will have to do something to make it possible for people to back up these tests” when things go wrong, he says of the technologist demand and supply problem.
The money to be spent on payment of royalties is another factor in weighing whether to create a molecular service. A critic of the patent system as it has been applied to genetic discoveries, Dr. Kiechle says, “Patents do impact the ability of clinical laboratories to set up tests.” One recent survey showed 25 percent of laboratory directors had discontinued performing genetic tests because of patents, and 53 percent said they did not develop new genetic tests because the gene was covered by a patent.
Royalties have posed obstacles for Spectrum Health in Grand Rapids. “We’ve stopped a few tests either for lack of use or because we ran into patent issues where the test volume did not support payment of royalties,” Dr. Thomas Monroe says. “If we’re only running 199 samples a year and only charging $50 to do it, it’s not worth the attorney fees.”
“We haven’t been forced to stop anything, but it’s always kind of looming over our heads. I’m looking at the mutation for JAK2 on my computer screen right now, and the holders of that patent just granted an exclusive license to a company to market it in Canada. I don’t know if that affects us in the U.S. or not.”
Anne Paxton is a writer in Seattle. Dr. Dan Hyder will be one of the speakers at the CAP ’07 session on molecular testing for the community pathologist, to be held Oct. 3 in Chicago. To register for the meeting, call 800-323-4040 option 1#.