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OIVD Wants to Discuss Oncotype Dx s Status With Genomic Health; More Insight Into FDA s IVD Goal?

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The US Food and Drug Administration has asked to meet with Genomic Health to learn more about the company's Oncotype Dx breast cancer test and its place in the market as a diagnostic, according to an FDA letter.

Though the letter implies that the agency may believe the home-brew test should have been approved as a device, its wording is significantly less blunt and considerably more benign than the "untitled" letter it sent to Roche for its AmpliChip [see 7/10/2003 PGx Reporter] or the "warning" letter it delivered to Nanogen for its NanoChip 400 System [see 8/25/2005 PGx Reporter].

Indeed, at least one molecular diagnostic expert believes the letter is little more than the FDA's way of telegraphing its interest in learning all it can about a test it had lauded publicly in the past, and a sign that the agency is paying closer attention to genomic-based molecular diagnostics.

In the Jan. 23 letter, which can be found here, the FDA's Office of In Vitro Diagnostic Device Evaluation and Safety said it "has reviewed reports indicating that Genomic Health is marketing the Oncotype DX ... [as one that predicts] distant disease recurrence ... [and assesses] ... a patient's benefit from certain types of chemotherapy.

"Under section 201(h) the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. § 321(h)), any instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part or accessory, which is intended for use in the diagnosis of disease or other conditions is a device," the OIVD letter reads.


"Maybe this is presaging what they want to do, which I think is … to see a diminishing of home-brews."

"We have no record that such a test has been the subject of premarket review by FDA," the letter concludes. "We invite you to meet with us at your earliest convenience to discuss the nature and appropriate regulatory status of your technology, and the least burdensome ways that Genomic Health may fulfill any premarket review requirements that may apply."

In a statement released Jan. 13 — the most recent one before it disclosed receiving the FDA letter — Genomic Health said the test "quantifies the likelihood of breast cancer recurrence and predicts the likelihood of response to chemotherapy for a large portion of early-stage breast cancer patients."

On its website, Genomic Health reports that the Oncotype Dx is "a diagnostic assay that quantifies the likelihood of breast cancer recurrence in women with newly diagnosed, early stage breast cancer. In addition to predicting distant disease recurrence, Oncotype Dx also assesses the benefit from certain types of chemotherapy."

To be sure, Oncotype Dx, which was launched in 2004, has been used by more than 2,000 physicians as part of their decision to treat more than 7,000 breast cancer patients, Genomic Health said in a statement on Jan. 27 disclosing the FDA letter. Additionally, Oncotype Dx is currently a CLIA-approved test and is performed at the company's Redwood City, Calif., central reference laboratory, which is itself accredited under CLIA and the College of American Pathology.

Furthermore, Genomic Health's lab and the Oncotype Dx test cleared "all required" CLIA evaluations before the first patient test was run and results reported, the company said.

Finally, Genomic Health reiterated in the statement comments made in a US Securities and Exchange filing in December 2004 that the FDA "contacted the company regarding the regulatory status of Oncotype Dx and the company subsequently engaged in informal communications with the FDA. In early 2005, the FDA indicated that it was considering whether Oncotype DX may be subject to FDA premarket review."

On Jan. 27, the day it disclosed receiving the letter, Genomic Health said it intends to comply with the letter's request for a meeting "in the near future."

The company's stock has fallen more than 10 percent since Jan. 26, taking a bite out of the 53-percent run-up in share price since the company said Jan. 13 that a Medicare contractor would cover the test [see accompanying chart]. A Genomic Health spokesperson said the company would not comment beyond what it said in its statement.

"In my opinion, this is an example of how the FDA is demonstrating that it's paying closer attention to this space," said Keith Batchelder, CEO and founder, Genomic Healthcare Strategies, a consultancy that focuses on pharmacogenomics. "It's the agency saying, 'We want to know what your claims are, we want to know whether you are moving into the kit space.'"

According to Batchelder, the letter doesn't suggest that Genomic Health has done something wrong that the FDA is now trying to remedy. "As far as I can see, technically, Genomic Health is meeting or exceeding the technical requirements for a home-brew.

"This is more of a demonstration of what the FDA is thinking about than any particular reflection" of wrongdoing by Genomic Health, Batchelder added. "Maybe this is presaging what they want to do, which I think is … to see a diminishing of home-brews."


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News of the letter comes two weeks after Genomic Health announced that the National Heritage Insurance Company, a Medicare contractor, will cover the Oncotype Dx test [see 1/18/2006 PGx Reporter] in certain US markets. It was not immediately clear whether the nature of the FDA's letter would affect this relationship. Officials from NHIC did not return calls seeking comment.

But Batchelder said: "I don't think [the letter] will have a significant impact [on the reimbursement decision] one way or the other. I think probably the criteria that has been used for selection of a diagnostic like this to be reimbursed has already been thought about. Unless they get something from the FDA saying that [the Oncotype Dx] is un-saleable."

Ironic Twist?

This letter also marks an ironic turn of events for Genomic Health. Last May, Larry Lesko, director of the Office of Clinical Pharmacology and Biopharmaceuticals at the agency's Center for Drug Evaluation and Research, publicly cited Oncotype Dx as an example of a promising model for pharmacogenomics-based diagnostics, and noted that although the test had not yet been submitted to the FDA for approval, the agency would "like them to bring it in." [see 5/26/2005 PGx Reporter]

While the comment was almost certainly an off-hand remark, it was the only commercial product that Lesko mentioned during his talk that had not yet received FDA clearance. Calls made to Lesko and the OCPB were not returned in time for this publication, but the FDA has an agency-wide policy not to comment on letters to companies.

According to Batchelder, Lesko's comment last May, like the letter, can be seen as the FDA's way of telegraphing its current thinking as well as a component of its future strategy for overseeing genomic-based molecular diagnostics.

— Kirell Lakhman ([email protected])

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