Now that its CYP450 AmpliChip microarray diagnostic has been safely cleared as an in vitro device by the US Food and Drug Administration, Roche is hinting at the marketing strategy it will use to put the test within reach — or at least on the minds — of clinicians.
This week the FDA finally granted AmpliChip clearance for the second of two genes interrogated by the test, 2C19, around three weeks after clearing the microarray’s 2D6 portion, along with the chip’s reader, made by Affymetrix [see Pharmacogenomics Reporter, 1/6/2005].
All that’s left now is to sell it, right? Not quite. An immature reimbursement environment in the United States and an army of physicians unfamiliar with the technology may conspire to slow AmpliChip’s ascent into the market.
So how will the Swiss diagnostic giant market and sell the product, which is the first microarray-based IVD ever to receive FDA clearance? Tita Forrest, head of commercial marketing for the AmpliChip, said the company’s plans could include running advertisements in clinical journals and continuing medical education courses.
“We plan on very targeted and select marketing efforts directed to physicians through different medical education venues,” said Forrest. “We intend on having a presence at this year’s American Psychiatry Association” meeting in Atlanta in May, “as well as targeted physician advertisements or marketing efforts,” she said.
Early market research conducted with academic and clinical practice psychiatrists showed them to be “very enthusiastic” about a CYP450 diagnostic, said Forrest. So initial marketing efforts will be directed to the psychiatry market, she said. “But in the future, you can expect marketing efforts for cardiology and even some oncology drugs, but that’s further down the line.”
Because psychiatrists do not regularly use diagnostic tests like AmpliChip, Roche will put significant muscle into “market awareness and education,” Forrest said. “They very much use empirical dosing, and that’s what they’ve used for years — so we hope that this will be a valuable tool for them in their practice.”
The applicability of the test is broad, but Roche will keep its focus narrow for the meantime. “If you look at the drugs that are metabolized by 2D6 and 2C19 — they’re pretty extensive,” said Forrest. “They metabolize about 25 to 30 percent of all commonly prescribed drugs.” The majority of drugs metabolized by 2D6 are antidepressants and antipsychotics, she added.
As part of clinician education and for sheer practicality, fresh research tying CYP450 genotypes to drug responses and dosages will be constantly needed. “Quite a lot” of CYP450 research is now being published, said a Roche spokesperson, including an upcoming article in the Journal of Clinical Psychology.
The company is currently speaking to insurers and payors about the “medical and economic benefits” of the test, although the specifics have not yet been worked out because the market is new, said Forrest. In particular, issues surrounding CPT codes can be “quite difficult” she said.
“Basic reimbursement” is available, and its extent is not yet known, although Roche will look for “novel methods,” said Forrest.
Sales of the CYP450 AmpliChip as an IVD will not begin in the United States for “a couple of months,” and the company does not yet have data on new customers, Forrest said. Roche launched AmpliChip in the EU about a month after receiving the union’s CE marking in early September.
However, interest in the diagnostic has grown in anticipation of FDA clearance and with the device’s CE marking in the EU, said Forrest. “We’re in the process of getting a lot of the instrumentation set up so that the test can be run,” she said. Forrest declined to comment on whether any drug companies would be recommending the use of the test to better gauge drug dosages.
The diagnostic sells for approximately €400 in the EU, according to a Roche spokesman. He declined to say how much they would cost in the United States, though industry consensus pegs the retail cost at around $500 per test.
Concerning upcoming AmpliChip products, Roche spokeswoman Paula Evangelista said the company no longer has formal launch dates. Upcoming AmpliChips will include assays for P53, “other cancer markers,” and leukemia, said Forrest.
Horst Kramer, head of media relations for Roche’s diagnostics division in Basel, Switzerland, told Pharmacogenomics Reporter in September that more chips would be released in “two to three years’ time,” although he declined to number them. Future chips would be produced for “differential diagnoses for various kinds of cancer,” including leukemia, breast cancer, lung cancer, and colorectal cancer, he said.