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2016 Issues

Procalcitonin passes automation hurdle

December 2016—Matt Damon in Interstellar. Julia Roberts in The Player. Gene Hackman in Young Frankenstein. When movie stars appear in uncredited parts, it’s usually for a cameo, not a leading role. But in diagnostics, an uncredited or off-label use of an assay might be its main use—possibly even its most clinically important use.

Highs, lows of immune checkpoint inhibitors

December 2016—Barry Nelson was the first in his cancer patient support group to undergo immunotherapy, which at the time was in a phase one clinical trial at Dana-Farber Cancer Institute. As the therapy became available to others in his group, they would ask for his advice on whether to try it. For the answer, he’d suggest they consult with their doctors and pray. He’d add, “I hope if you decide to go with it that you’ll have the same results that I do.”

Lymphoid neoplasms: Steven Swerdlow on classification revisions

December 2016—In his CAP16 talk, “Lymphoma Diagnosis and Classification: My Search for the Holy Grail,” Steven H. Swerdlow, MD, acknowledged that the quest has been long and contentious and the resulting classification complex. Why, he asked, is lymphoma classification so complex? It reflects an explosion of knowledge about the immune system and lymphomas and an increasing number of therapeutic targets requiring increasingly precise diagnoses. In other words, it reflects the complexity of the disease itself. As oncologist Alan C. Aisenberg, MD, PhD, wrote in 1995, “The complexity of non-Hodgkin’s lymphoma reflects the complexity of the lymphoid system.”

Is the value of hospital lab outreach underrated?

December 2016—Hospitals across the nation have been selling their laboratory outreach operations to national laboratories, which have been snapping them up from community hospitals and larger enterprises. Take Henry Mayo New-hall Hospital in California (LabCorp) and Hartford HealthCare in Connecticut (Quest Diagnostics) this year, for example, and MemorialCare in California (Quest) in 2015.

Medicare revises 2017 discount on add-on codes: Increases professional, cuts technical, pay for prostate biopsies

December 2016—Overall Medicare reimbursement for some professional pathology services will rise in 2017 due to increases sought by the CAP for add-on codes and other services provided by pathologists to Medicare beneficiaries. At the same time, the Medicare program will move forward with cuts affecting the technical component of pathology services, including flow cytometry, due to a targeted revaluation mandated by federal law.

From the President’s Desk: Where we direct our gaze, 12/16

December 2016—I gave a talk for the CAP16 House of Delegates in September that opened with a three-minute video showing how perspective can change along a continuum of distance (www.bit.ly/friedberg-cap16). The clip depicts a logarithmic journey across space from a grassy field in downtown Chicago to the farthest reaches of outer space, then retraces and extends its path to the deepest interior (“inner space”?) of human cells.

New protocols on deck as pathology helps reshape cancer staging

December 2016—It’s a familiar campus lament. New editions of textbooks in some academic fields have become notorious for providing little more than a few extra paragraphs of text or a few more references and altered pagination—mainly, students suspect, to serve as a damper on the textbook resale market. What is happening with a key text in the field of cancer care, however, is in marked contrast. The changes contained in the 8th edition of the AJCC Cancer Staging Manual of the American Joint Committee on Cancer, slated to take effect Jan. 1, 2018, are the opposite of cosmetic.

Isolated hepatic neuroendocrine tumor expressing albumin mRNA and arginase-1

December 2016—CAP TODAY and the Association for Molecular Pathology have teamed up to bring molecular case reports to CAP TODAY readers. AMP members write the reports using clinical cases from their own practices that show molecular testing’s important role in diagnosis, prognosis, and treatment. The following report comes from the University of Pittsburgh Medical Center.

What molecular diagnostics laboratory systems offer

December 2016—As personalized and predictive medicine have progressed from not-in-my-lifetime to now available, health care information technology vendors have faced the challenge of how to manage a mass of molecular data and direct molecular testing processes. CAP TODAY asked vendors of molecular diagnostics lab information systems to explain what their products contribute to the flourishing field of molecular testing. Here are their responses.

Recent approvals and the pipeline

December 2016—Pembrolizumab (Keytruda) is now FDA approved as monotherapy for patients with untreated metastatic NSCLC, both squamous and nonsquamous histologies, that express PD-L1 at a high level of 50 percent or more, says Dr. Roger Dansey, who headed up Keytruda development at Merck Research Laboratories. “We do not have data at this point that would say whether a cutpoint lower than 50 percent in the first-line setting would be of equal value in terms of response to Keytruda,” he says.

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