AMP lays out clinical utility standard for molecular Dx

The Association for Molecular Pathology has published a 14-page report its leaders hope will reset the conversation payers, policymakers, and medical guideline panels have when assessing the clinical utility of molecular diagnostics in oncology and inherited diseases. The key to AMP’s approach is to broaden the standard for what is considered a clinically useful molecular diagnostic test.

“We tried to take an inclusive approach and look at patients, providers, and clinicians, and we tried to address clinical utility from all those standpoints,” says Elaine Lyon, PhD, co-chair of the AMP Framework for the Evidence Needed to Demonstrate Clinical Utility Task Force. The panel met for two years to develop the document, “The Spectrum of Clinical Utilities in Molecular Pathology Testing Procedures for Inherited Conditions and Cancer: A Report of the Association for Molecular Pathology” (Joseph L, et al. J Mol Diagn. 2016;18[5]:605–619).

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As diabetic CKD takes toll, work on tests continues

When nephrologist Katherine Tuttle, MD, first saw the photo of two women holding young children, she thought it captured the mother of the boy and girl sitting on a couch with the children’s grandmother.

The younger-looking woman, 33 at the time the photo was taken, works in the clinical research group at Providence Health Care, Spokane, Wash., where Dr. Tuttle is executive director for research. Flashing a smile in the photo, Dr. Tuttle’s colleague held in her arms a baby girl who munched on her toy. Seated next to her was a woman whom diabetologists would recognize as having lost sight in one eye, with a two-year-old boy on her lap. Her face, deeply lined with wrinkles, bore a glum expression.

Contrary to Dr. Tuttle’s first impression, that second woman was no grandmother. She, too, was 33 years old, a cousin of Dr. Tuttle’s colleague and the mother of the two-year-old boy. Diagnosed with type 1 diabetes at 12, she had been on hemodialysis for two years by the point the photo was taken and had lost vascular access. Due to her son’s birth, the woman was highly sensitized and no kidney donor could be found.

“She was dialyzing via a hemodialysis catheter, and if you are a nephrologist you’d say she was probably not receiving very good dialysis based on the way she looked,” Dr. Tuttle said during a talk at the American Association for Clinical Chemistry’s annual meeting in August. “She had been thinking about stopping dialysis, but she didn’t have to make that choice because she was found dead about six weeks after this picture was taken.”

“This is what youth-onset diabetes looks like by the 30s, when people are supposed to be enjoying the prime of life,” she added. “It doesn’t matter if you’re type 1 or 2. It doesn’t matter what color you are. It’s really tragic, and it should be preventable.”

But preventing kidney failure requires new therapies and better biomarkers to help develop, test, and monitor the effect of those treatments. Slashing the rates at which patients with diabetes develop and die of kidney disease also depends on improved clinical use of existing tests and standardization of urine albumin and the cystatin C-based estimate of glomerular filtration rate, said Dr. Tuttle and her co-panelists during the AACC session, “Diabetic Nephropathy: Where Are We Now?”

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Top court clarifies autopsy’s place in Texas law

The Texas Supreme Court has decided, in the case of Christus Health Gulf Coast v. Carswell, that a hospital-provided autopsy falls under the scope of the state’s medical liability statute. The plaintiff, Linda Cars­well, alleged that professionals at Christus St. Catherine Hospital in Katy, Tex., defrauded her by refusing to request that an autopsy for her husband—who died as a hospital inpatient—be performed by the county medical examiner’s office. The autopsy was instead performed by a hospital-contracted pathology group. Carswell’s attorneys alleged this was done as part of an effort to hide some medical error-related cause of death.

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Missed UTIs? ‘Enhanced cultures’ suggest so

The long-held belief that urine is sterile is facing a serious challenge from new research combining sequencing techniques and an enhanced urine culturing protocol to uncover an array of uropathogens hitherto unseen in microbiology laboratories.

The notion that urine, indeed the entire bladder, is sterile is one medical students are still taught and “it’s a pretty deeply entrenched dogma,” says Linda Brubaker, MD, a urogynecologist and professor of obstetrics and gynecology and urology at Loyola University Chicago Stritch School of Medicine. She and a team of Loyola colleagues have worked for years to learn more about urinary microbiota and in the process demonstrated that currently standard urine culturing techniques fail to spot an alarmingly high proportion of uropathogens that may well be clinically relevant. Their findings were presented in June at the American Society for Microbiology’s Microbe meeting.

“What we’re going to do is replace the dogma that clinical care is based on,” Dr. Brubaker says. “There is a great deal of excitement because this is a vast unknown. It’s like discovering a tribe in the middle of the Amazon. We never knew these people were here, or how they eat, or how they live. We have to understand this [bacterial] community now—how it maintains health, how it deals with perturbations, like when patients are catheterized and a certain number of patients will get infections. Not all of them do. We may learn why some do and some don’t.”

My cover story in the August issue of CAP TODAY. Read the whole shebang.

Structured illumination microscopy used to detect nephrotic kidney disease

Structured illumination microscopy, or SIM, offers an alternative to electron microscopy in viewing details that are below the resolution limit of standard light microscopy. SIM was applied recently to analyze renal podocyte substructure in nephrotic kidney disease, and the findings corresponded with those obtained using electron microscopy (Pullman JM, et al. Biomed Opt Express. 2016;7[2]:302–311).

That is important, says lead author James Pullman, MD, PhD, because electron microscopy, or EM, techniques require specially trained technicians and a time-consuming process of preparing, imaging, and analyzing a single sample using EM. SIM also gives protein localization by immunofluorescence the high resolution of EM.

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Michel: The good, bad, and ugly that labs need to know

Robert Michel’s opening remarks at the Executive War College, which can be seen as a kind of state of the union address for laboratory medicine, focused on the trends in the industry and the opportunities and dangers they create.

“Fraud and abuse. That’s the ugly,” Michel began. “Folks who are doing lab medicine the right way aren’t really aware of what’s been happening outside the walls of their laboratories.”

From July’s “Put It on the Board” section of CAP TODAY. Read the whole shebang.

Laboratory 2.0: Changing the conversation

Bundled payments, physician employment, and unconventional competitors are cannibalizing the volume-based business model that for decades has defined laboratory medicine. And labs have little room within their customary confines—the three percent of health system spending they directly account for—to play a central role in American medicine’s transformation.

TriCore Reference Laboratories CEO Khosrow Shotorbani, MT(ASCP), put the matter succinctly to a group of laboratory leaders and other health care experts who met in Santa Fe, NM, this spring to tackle the conundrum of how to move from volume to value.

“The question is,” Shotorbani said, “how do we survive in the future? If there is no margin, there is no mission.”

Altering the discourse and, ultimately, the practice of laboratory medicine is the ambitious goal of the invite-only brainstorming sessions among two dozen heavy hitters in health care. The think-tank-style venture, dubbed Project Santa Fe, includes leaders from five of the most innovative clinical laboratory operations in the country: TriCore; the Henry Ford, Geisinger, and Kaiser Permanente Northern California health systems; and New York’s Northwell Health (formerly known as North Shore-LIJ Health System).

The project brings to mind the R&D that took place just 30 miles away in Los Alamos, NM, where more than 70 years ago the scientists of the Manhattan Project raced to beat the world’s totalitarian powers in developing a nuclear weapon. Project Santa Fe participants, too, see themselves in a contest where time is of the essence. What’s needed to beat the clock before fee-for-service dies, they say, is an enterprising, aggressive strategy that aims for a wholly new understanding of the laboratory’s role in medicine. Call it lab 2.0.

The lede for my  cover story in the July issue of CAP TODAY. Read the whole shebang.

Eco effort cuts biohazard waste, saves money

An environmental initiative at the Cleveland Clinic laboratories has increased recycling by 20 percent and reduced biohazardous waste hauling charges by an estimated $10,000 a year. The effort succeeded by expanding the categories of items that could be tossed in recycling bins instead of into biohazard containers, and by working to educate laboratory professionals through a “know where to throw” campaign.

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Guidance seen as sign of FDA openness to digital pathology

The Food and Drug Administration has issued final guidance for industry and agency staff on how to assess the technical performance of whole-slide imaging devices. During a Digital Pathology Association webinar on the FDA action, experts said the guidance is another strong sign of the agency’s working to detail the standards manufacturers will need to meet to earn approval for WSI’s use in primary diagnosis.

The lead item in  CAP TODAY’s “Put It on the Board” section.  The whole shebang.

Logistics hurdles overcome for single Pap-HPV report

Is one test better than two? That question—primary HPV versus the Pap-HPV cotesting option—has roiled the world of cervical cancer screening since the Food and Drug Administration approved a primary HPV screening test in April 2014. However clinicians decide to answer that question, this much is clear: A single report is better than two separate results.

That was the conclusion that leaders at Northwestern Memorial Hospital’s cytopathology laboratory came to in concert with their ob-gyn colleagues after changes were made to cervical cancer screening and management guidelines. At Northwestern, the high-risk HPV/genotyping and the cervical cytology results are combined into a single report that is sent to clinicians through the electronic health record system.

My lead piece in this month’s “Put It on the Board” section of CAP TODAY. Read the whole shebang.

In late flu season, early signs of new tests’ impact

The 2015–2016 influenza season is shaping up to be lighter than physician offices and hospitals have seen in recent years, with fewer flu positives reported, a lower death count, and a smaller share of flu-like illnesses among outpatients.

Last year’s flu season, by contrast, was “very hectic,” says MAJ Charlotte Lanteri, PhD, deputy chief of microbiology at Brooke Army Medical Center at Fort Sam Houston in San Antonio, Tex. It is not just the lower number of patients presenting with flu-like symptoms in the medical center’s inpatient and outpatient settings that has made for a quieter season so far, she says. Also contributing to the peaceful, easy feeling at Fort Sam Houston—at least as regards the flu—is the medical center’s implementation of a rapid molecular test for influenza A and B.
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Case raises uncertainty on autopsy’s legal status

Should a hospital-provided autopsy be considered health care? It’s a question the Supreme Court of Texas will decide this spring, and its answer to that question will make a big difference—in the millions of dollars—to the claimants, Christus Health Gulf Coast v. Carswell. It could also have an impact on the medical liability coverage available to pathologists who perform autopsies in the Lone Star State.

My lede for the top item in this month’s “Put It on the Board” section in CAP TODAY.