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CAP Today




June 2013

News read or heard lately

Amin named editor-in-chief of AJCC Cancer Staging Manual

The American Joint Committee on Cancer announced that Mahul B. Amin, MD, has been named editor-in-chief of the eighth edition of the AJCC Cancer Staging Manual, which is expected to be published in late 2015.

“This position, traditionally the domain of oncologists and surgeons, reiterates the central position of pathology in today’s cancer care,” says Dr. Amin, professor and chairman, Department of Pathology and Laboratory Medicine, Cedars-Sinai Medical Center, Los Angeles. “It bridges the traditional role of histologic characterization of cancer and staging defined by anatomic extent of disease with the promise of integration of genomic biomarkers and precision medicine.”

David P. Winchester, MD, medical director of cancer programs, American College of Surgeons, said in a statement that Dr. Amin “brings a multidisciplinary approach to the editor-in-chief position, in addition to a molecular-based medical perspective of cancer staging.”

The eighth edition of the manual will incorporate advances made in cancer research, staging, diagnosis, and treatment since the seventh edition was published in October 2009. “We will incorporate the newer precision medicine paradigms, as appropriate, into the more traditional anatomic extent of disease premise of the AJCC staging classification,” Dr. Amin said in a statement. The editorial development process will involve a collaboration of more than 500 cancer experts worldwide and cover more than 60 primary disease sites.

Dr. Amin said that for the new edition, “we want to make our staging system more relevant for both the treating physicians at the individual level as well as the surveillance community at the population level.” Dr. Amin was a member of the AJCC’s executive committee from 2003 to 2011 and is a coauthor of the current WHO classification systems for urothelial tumors and renal neoplasms.

CollabRx, GeneInsight to create genetic sequencing service

CollabRx and software developer GeneInsight will establish a medical informatics solution to support genetic sequencing, interpretation, and reporting in the clinical laboratory.

Under terms of the agreement announced recently, CollabRx medical and scientific content will be made accessible through the GeneInsight knowledge management platform, which has been in use since 2005 and has supported the interpretation of and reporting workflow for more than 30,000 clinical genetic tests across multiple diagnostic reference laboratories.

The combined offering in oncology will enable clinical laboratories to catalog genetic variants from sequencing-based tests, and associate the variants with CollabRx’s expertly curated knowledge of available drugs and clinical trials. Laboratories will be able to incorporate this information into reports for physicians. Knowledge management, reporting, and delivery of findings to ordering clinicians will be streamlined through GeneInsight’s networked infrastructure, providing clinical labs with the means to update physicians as knowledge evolves.

“The CollabRx and GeneInsight collaboration will enable laboratories using GeneInsight to leverage CollabRx content as they draft reports explaining the significance of variants identified in patients,” Heidi Rehm, PhD, chief laboratory director, Partners’ Laboratory for Molecular Medicine, said in a statement. Partners Healthcare developed the GeneInsight Suite of IT tools, and GeneInsight LLC is a Partners subsidiary.

Aperio ePathology approved for routine diagnostic use in Canada

Leica Biosystems’ Aperio ePathology solution has obtained a Health Canada class II medical device license. This clearance allows pathologists to use the system as a diagnostic tool.

“We understand the role that pathology plays in cancer and other diseases, and we believe improving access and transparency of pathology expertise will improve health outcomes,” Jared Schwartz, MD, PhD, chief medical officer, Leica Biosystems, said in a statement. “We have been working with leading centers in Canada to support the transformation in their practices to ensure easy adoption, which ultimately benefits patient findings and treatment.”

The University Health Network Laboratory Medicine Program in Toronto has used Aperio ePathology solutions since 2006. “We are pleased that Health Canada has embraced this technology, as we have done over the past seven years,” Sylvia Asa, MD, PhD, UHN pathologist-in-chief and medical director, said in a statement. The Omnyx integrated digital pathology system also obtained a Health Canada class II medical device license. (See CAP TODAY story)

From Transgenomic, RAScan mutation test for metastatic CRC

Transgenomic on May 16 announced worldwide availability of the CRC RAScan test to screen patients with metastatic colorectal cancer for KRAS and NRAS mutations. Transgenomic collaborated with Amgen to develop the CRC RAScan kit.

Transgenomic’s clinical trials service lab performed mutation analysis work as part of a predefined-retrospective study of metastatic colorectal cancer patients as a subset of its global, multicenter, randomized phase three study of metastatic CRC patients and drug response. The study was presented at the ASCO annual meeting this month, says Craig Tuttle, Transgenomic CEO.

“In this mutation analysis, we used standard Sanger sequencing combined with our in-licensed Surveyor mismatch detecting enzyme,” he says. Surveyor detects DNA mismatches and makes a double-stranded cut of the DNA fragment. “By sizing on a microcapillary electrophoresis system, we improve the detection sensitivity of finding known and unknown mutations in target genes from the typical Sanger sequencing cutoff of 15 percent to 20 percent mutant-to-wild type to somewhere below two to five percent,” he says. Surveyor does not indicate the exact position of a mutation, he says, but the fragment length does indicate the near specific site of the mutation, “and, knowing that, one can then look closely at the Sanger sequencing electropherogram to call the mutation at this much lower level.”

Based on the success of this trial, Tuttle says, Amgen contracted with Transgenomic to support and fund the development of specific cancer gene mutation kits for several new exons in KRAS and NRAS, plus the production and registration of the kits for CE-IVD.

Research-use-only kits will soon be available in the United States, says Tuttle, who adds that Transgenomic now offers the CRC RAScan testing out of its own laboratory as a lab-developed test.

FDA OK for bioMérieux’s THxID-BRAF

BioMérieux’s molecular test THxID–BRAF received premarket approval from the FDA. The test is intended for the qualitative and simultaneous detection of both BRAF V600E and V600K mutations in late-stage metastatic melanoma tumor samples.

The test is a companion diagnostic to be used to select melanoma patients whose tumors carry the BRAF V600E mutation for possible treatment with GlaxoSmithKline’s Tafinlar (dabrafenib) as well as to select melanoma patients whose tumors carry the BRAF V600E or V600K mutation for possible treatment with Mekinist (trametinib). GSK and bioMérieux, whose collaboration began in 2010, continue to work on new uses for the THxID-BRAF assay.

Commission advises scrapping SGR

The sustainable growth rate, or SGR, has not worked and shows no prospect of ever working, according to members of the National Commission on Physician Payment Reform, which issued in March a dozen recommendations for changing current methods of physician payment. One of its recommendations is that Medicare’s SGR adjustment be eliminated.

Writing for the commission in a “Sounding Board” published May 23 in the New England Journal of Medicine, Steven Schroeder, MD, commission chair, and William Frist, MD, honorable chair, say setting expenditure targets for one year and “ignoring the consequences of exceeding them the next year makes no sense.” They call setting a spending cap without addressing the underlying issues of the volume and price of services and health outcomes “a short-term answer to a problem that requires a long-term solution.”

Members of the commission believe that the $138 billion that the Congressional Budget Office estimates will be needed to offset the SGR elimination can be found entirely by reducing overuse of medical services within Medicare, they write.

The group also recommends that the Relative Value Scale Update Committee, which the AMA manages and consists of members named by specialty societies, “continue to make changes to become more representative of the medical profession as a whole and to make its decision making more transparent.” As it is, write Drs. Schroeder and Frist, “its composition and operations are flawed.”

The commission’s first recommendation is that over time, payers largely do away with standalone fee-for-service payment. Its report can be seen online.

Dr. Schroeder is in the Department of Medicine, University of California, San Francisco, and Dr. Frist is in the surgery departments at Vanderbilt University School of Medicine and Meharry Medical College, Nashville.