Medical Device Daily Washington Editor
The Centers for Medicare & Medicaid Services will convene a meeting of the Medicare Coverage and Evidence Development Advisory Committee (MedCAC) in January 2010 to examine the evidence behind pharmacogenomic testing for cancer in an attempt to determine the need for a coverage determination.
The Nov. 25 announcement states that the meeting, scheduled for Jan. 27, will review the evidence for genetic testing for five gene/treatment pairings, two of which are for breast cancer treatments. One of these is for the use of tamoxifen in relation to the CYP2D6 gene (one of the cytochrome P450 genes), and the second is the use of trastuzumab for the HER2/neu (human epidermal growth factor receptor 2) gene. The three other tests involve irinotecan for colon cancer (UGT1A1), imatinib for chronic myelogenous leukemia (BCR-ABL) and cetuximab for colorectal cancer (K-ras).
CMS acknowledges in the announcement that "evidence from clinical studies suggests that tumor genetic factors may be significant markers or predictors for a tumor's development and sustained growth" as well as for a tumor's "likely response to certain anti-cancer agents." The statement also notes that the agency "is aware that the body of evidence on the role of pharmacogenomic testing in cancer continues to evolve."
Michael Stocum, managing director of Personalized Medicine Partners (Raleigh, North Carolina) told Medical Device Daily that the majority of these scenarios are at least fairly well understood. "For most of them, it's strongly fleshed out," he said. Regarding the use of imatinib for chronic myelogenous leukemia (CML), he said, "the very mechanism that drives CML can be translocated" with the drug, which he said "markedly drives outcomes." He posed the question, however, of whether other factors have to be addressed, including whether other genes ought to be checked and whether messenger RNA should be examined.
As for the use of tamoxifen in breast cancer, Stocum, who chairs the personalized medicine advisory group at the American Association for Clinical Chemistry (Arlington, Virginia) said, "this has been pretty well published." Of the group, he said the case for irinotecan for colon cancer is the spottiest, but that the others are well supported by existing evidence.
Dental syringe maker snares warning
There's no news to the assertion that the 510(k) program at FDA is under tight scrutiny, but apparently a New York maker of dental syringes is not clear on when it is required to file a 510(k). The Nov. 10 warning letter to Arnold Tuber Industries/dba Sci-Dent (Hamburg, New York) listed more than a dozen deviations from the quality systems regulations, but the July 27-31 inspection resulted in a citation for failure to file a 510(k) for an unnamed device.
However, the 510(k) issue was not the biggest problem the firm had as FDA cited the firm for lack of procedures for medical device reports as well as design control procedures. Among these routine GMP findings was that the firm failed to establish procedures for control of "the aspirating dental injection syringes that were designed by the firm in 2004" and shipped to an unnamed customer since then. The warning letter makes no mention of a proposed resolution to this or any other finding.
The following citation, however, notes that the company lacked procedures for approval of changes prior to implementation. According to FDA, "a change was implemented for the design of the hub on the [redacted] aspirating dental injection syringe because the hubs were falling off and the needles would not stay on." However, Sci-Dent is said to have lacked documentation supporting "the verification, review, and approval of design change."
The problem with the aspirating syringes extended to the firm's device master records (DMRs). According to FDA, the DMR for the aspirating dental injection "failed to include information about the type of dental glue used for the assembly of the hub and extension components and the master approved top level drawings." Among the other citations were those for lack of complaint-handling procedures and device acceptance protocols, and the agency also cited Sci-Dent for the absence of documentation for software used in the manufacture of aspirating syringes.
FDA also said that Arnold had not appointed a management representative to the firm's quality system and that management had not "reviewed the suitability and effectiveness of the quality system at defined intervals and with sufficient frequency."
The company did not respond to a call for comment.
Kappos: filers should be proactive
The outcome of the Supreme Court hearing in the patent obviousness case of KSR v. Teleflex were initially expected to be immediate, but some observers were of the view that filings at the Patent and Trademark Office over the past two and a half years since the decision have not reflected much of a change. However, the recently appointed director of PTO, David Kappos, posted a blog last week to inform patent applicants that the effect of KSR might start creeping into patent examiners' work.
In a Nov. 24 blog, Kappos remarked that the April 2007 decision broadened a patent examiner's approach "beyond the strict teaching-suggestion-motivation test," and that applicants "asked us to provide examples of non-obvious claims" in the new paradigm. He said PTO staff are reviewing past cases to supplement a recent guidance on the issue "to illustrate the developing law of obviousness."
Kappos warns that the outcome of the Supreme Court decision means that "some claims that may have been found to be non-obvious before KSR will now correctly be found to be obvious."
Kappos suggests that applicants consider reviewing "a broader cross-section of prior art than was previously necessary," or consider "filing evidence of unexpected results earlier rather than later in the course of prosecution." He concludes that such a proactive stance in the KSR era may help applicants "expedite prosecution and avoid unnecessary fees and filings."
Mark McCarty, 703-268-5690