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IN THIS MONTH’S ISSUE

Pathology articles from the current issue.

Next act in genomics: the consumer orders

April 2019—For years, laboratories have chafed against testing being, literally and figuratively, an out-of-sight, out-of-mind transaction. Now a new, highly visible era in genetics may be pushing testing the other way, into the hands of consumers who value entertainment as well as medical information. Anyone who wants to write a book about this shift has a ready-made title: From Basement to Big Top. It’s not that clinical testing is becoming an actual circus. But ever since the first consumer genetic tests entered the market in 2007—in a nonphysician-ordered, SNP array technology way—labs, physicians, and regulatory agencies have had plenty to juggle.

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Quantitative image analysis: In guideline, preliminary rules for pathology’s third revolution

April 2019—With the release in January of a new guideline for quantitative image analysis of HER2 immunohistochemistry for breast cancer, the CAP believes it is filling a gap and blazing a trail for the profession. In setting evidence-based standards, the guideline provides background and details about the quantitative image analysis (QIA) process and the data and metadata it generates. The guideline will help facilitate pathology’s increasing use of not only digital pathology but also artificial intelligence, says Marilyn Bui, MD, PhD, chair of the CAP expert panel for QIA of HER2 IHC. “This is not just another guideline. It is a milestone for pathologists.”

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Too few technologists: labs take inventive steps

April 2019—The tight supply of technologists to fill open positions is pushing laboratories to be creative in finding answers. Memorial Sloan Kettering Cancer Center and TriCore Reference Laboratories found their answers by looking not just outward but also—and largely—inward. MSK has created an innovative Laboratory Scholars Program that draws employees from other parts of the cancer center, places them in an education program in coordination with a partnering college, and retrains them to become laboratory technologists.

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AMP case report: Acute promyelocytic leukemia with cryptic t(15;17) identified by RT-PCR

April 2019—Acute promyelocytic leukemia (APL) is a subtype of acute myeloid leukemia (AML) in which promyelocytes predominate. APL accounts for about 10 percent of AML cases, and although APL can be diagnosed at any age, it is most common among young adults with a slight male predominance.1 APL is defined by the balanced reciprocal translocation (15;17)(q22;q21) between PML and RARA, although variant translocations involving RARA and other partner genes can occur. The fusion results in uncontrolled cell proliferation and inhibition of cell differentiation.

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Put It on the Board

Shield launches test 
for antibiotic susceptibility 
in N. gonorrhoeae April 2019—Shield Diagnostics launched Target-NG, a rapid molecular test for antibiotic susceptibility in Neisseria gonorrhoeae. “Rapid molecular testing for ciprofloxacin resistance allows for smarter medicine,” Jeffrey D. Klausner, MD, MPH, a professor of infectious disease medicine at the University of California, Los Angeles, said in a Shield statement. “Right now we’re treating gonorrhea with a sledgehammer; we’re treating everything with the same exact regimen. And it’s not a surprise that the organism will become resistant to what we’re currently using.” Ciprofloxacin can be used to treat 80 percent of infections and is 99.8 percent effective when susceptibility has been determined. Because it is administered as a single oral dose, rather than the current injectable treatment, clinicians can prescribe antibiotics for the patient to give to their partners. “Shield has launched Target-NG to help clinicians adopt a precision medicine approach to gonorrhea treatment,” said Nidhi Gupta, PhD, lead scientist on the project.

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