December 2019

December 2019—At Mayo Clinic, the latest generation of cardiac troponin assay was an overnight success. Literally. For months, the institution had been preparing to switch to Roche Diagnostics’ Elecsys Troponin T Gen 5 Stat assay, says Bradley S. Karon, MD, PhD, chair of the Division of Clinical Core Laboratory Services, Department of Laboratory Medicine and Pathology. As the time of the rollout neared, an internal medicine colleague who was involved in overseeing the transition asked, “‘What will the burn-in period be?’” recalls Dr. Karon, who is also co-director of Mayo’s stat labs and point-of-care testing programs. Surely clinicians would be able to continue ordering the Gen 4 assay for a time, right? So how long would that last? Dr. Karon’s dramatic-sounding answer? “Zero hours.”  

December 2019—The controversy surrounding the approved methods for screening gestational diabetes mellitus took the form of a debate at this year’s AACC annual meeting, with two speakers defending the one-step or two-step method.

December 2019—There aren’t good flu seasons; there are just varying degrees of how bad they are. That’s the message the CDC wants people to hear, says Lynnette Brammer, MPH, lead for the CDC’s domestic influenza surveillance team. It’s what laboratories know well and why platforms, panels, and prescribing patterns are top of mind.

December 2019—For point-of-care testing, perform proficiency testing on only one method or instrument unless your testing procedure says all patient samples must be tested on multiple instruments. And if a single IQCP is written for more than one POC testing location, account for all variations.

December 2019—Medicare reimbursement to pathologists in 2020 is estimated to remain steady, but significant cuts in payments to pathologists and other specialists are expected in 2021 owing to a dramatic shift in how primary care physicians will be paid. The CAP is already fighting the scheduled cuts to pathologists in 2021 as a result of a new plan that reimburses evaluation and management office visit services at a higher rate and lowers payments for non-E/M services billed by specialists.

December 2019—IT as it relates to laboratory consolidation and the labor supply for lab IT were some of what came up when CAP TODAY publisher Bob McGonnagle convened a panel in September to talk about laboratory information systems. Part one of the discussion is in the November issue (with the LIS product guide); part two begins here. On the panel were J. Mark Tuthill, MD, of Henry Ford Health System, Curt Johnson of Orchard Software, Wally Soufi of NovoPath, Michelle Del Guercio of Sunquest Information Systems, Nick Trentadue of Epic, Sepehr Seyedzadeh of Siemens Healthineers, and Tony Barresi of Beckman Coulter.

December 2019—“If you thought that diagnosing gestational diabetes at 24 to 28 weeks was unsettled, you haven’t seen anything yet.” That was David B. Sacks, MB, ChB, of the National Institutes of Health, speaking this year in the AACC session on gestational diabetes mellitus (GDM) with his co-presenters who debated the use of the one-step and two-step methods for diagnosing GDM in the second and third trimesters (see story, page 1). His talk: “Let’s Not Wait: Diagnosing GDM in the First Trimester.”

December 2019—What do users of urinalysis systems want? According to those in the know, the answer is instruments that are scalable and modular, maximize automation, reduce hands-on time, improve workflow, and more. CAP TODAY publisher Bob McGonnagle convened a panel in October to discuss these topics and other aspects of urinalysis testing. On the panel were Megan Nakashima, MD, of Cleveland Clinic; Michelle Dumonceaux, of Beckman Coulter; Maya Daaboul, of Siemens Healthineers; and Jason Anderson, MPH, MT(ASCP), of Sysmex. What they said follows.

December 2019—We report a case of a 34-week-gestation male infant with prenatal overgrowth born to a 19-year-old G1P0 mother. No significant family history or consanguinity were reported. The infant was delivered emergently by cesarean section due to pregnancy-induced hypertension and polyhydramnios.

December 2019—Presentations at the recent Cancer Biomarkers Conference IV, sponsored by the University of Mississippi Medical Center, prompt reflection on how far we have come since the introduction of Rituxan, the first monoclonal antibody to be approved by the Food and Drug Administration for the treatment of cancer in 1996. Before the launch of Rituxan, physicians were skeptical about the efficacy and safety of monoclonal antibody therapy because of the history of failures.

December 2019—Don’t even try to put Boca Biolistics into a box. The Pompano Beach, Fla., company is the rare outside-the-box model of three levels of service under one roof: an expansive biorepository, a contract research organization, and a reference laboratory that earned CAP accreditation in March. Joseph Mauro, president and CEO of Boca Biolistics, has been developing the “new” model for two decades. “The thing that makes us different is that we’re a vertically integrated company encompassing a biobank, CRO, and reference lab. There aren’t many players in this space. LabCorp and Quest have been buying CRO companies, so they are moving into that area, but they are not biobanks. They do not have all of the platforms we have.”

FDA grants de novo designation to NGS HIV-1 genotyping assay
December 2019—Vela Diagnostics received FDA authorization to market its in vitro diagnostic test for the detection of HIV-1 genomic drug resistance mutations. The Sentosa SQ HIV-1 Genotyping Assay uses the plasma of patients infected with HIV-1 to detect HIV-1 Group M drug resistance mutations in the protease, reverse transcriptase, and integrase regions of the pol gene, in a single test. It is the first HIV-1 genotyping NGS assay to receive marketing authorization from the FDA. In a Nov. 5 statement, Vela acting CEO and chairman of the board Sam Dajani called the FDA’s granting of the de novo designation to the NGS assay “a major milestone in HIV diagnostics.” “With the Sentosa SQ HIV-1 Genotyping Assay, laboratories will now have a sample-to-report solution to aid in monitoring and treating HIV-1 infection,” he said. The assay is validated on the Sentosa NGS workflow that enables automated RNA extraction, PCR setup, library construction, template preparation, sequencing, data analysis, and automated reporting.

Q. How do you report the presence of immature granulocytes in a 100-cell differential? Read answer. Q. Should a patient with a hematocrit greater than 55 percent be redrawn for correction always or only when prothrombin time and partial prothrombin time are elevated? Read answer.

December 2019—This time of year, it’s easy to find ourselves caught up in holiday planning and the challenges of managing a busy team’s hectic vacation schedule. But it is also the appropriate time to look ahead to the coming year and think about the opportunities as well as the challenges we should expect. Here’s what I can say for sure about next year and the years after that: The importance of pathologists and the laboratories that we direct will increase. Already, the majority of diagnoses and therapies are greatly influenced, if not outright dictated, by pathologists and our laboratories.

How a local startup solved a lab’s slide-management issues December 2019—When Alex Bushell, the young CEO of a Canadian startup, approached Bernard Schaan, the now-retired laboratory manager at Peterborough Regional Health Centre, in 2017, to ask what problem they might tackle together, Schaan mentioned an issue that had nagged him for years: histology slide filing and retrieval. Tasked with filing between 125,000 and 135,000 slides per year, “I thought the process could be automated and had been asking various sales reps if there’s anything out there—and they said no, there wasn’t,” Schaan says.

Intraoperative red blood cell transfusion and mortality after cardiac surgery
December 2019—Patients with underlying cardiac disease are at risk for myocardial ischemia if they have untreated anemia at the time of cardiac surgery. During surgery, ongoing blood loss and hemodilution as a result of cardiopulmonary bypass (CPB) cause low hemoglobin levels. The optimal transfusion trigger for cardiac surgery patients continues to be debated. A more restrictive RBC transfusion strategy is used in patients with stable cardiovascular disease and is considered safe.

Evaluation of tumor quantitation as an aid in predicting biochemical recurrence in organ-confined prostate cancer
December 2019—In the eighth edition of the AJCC Cancer Staging Manual, all organ-confined disease is assigned pathologic stage T2, without subclassification. The authors investigated whether total tumor volume (TTV) or maximum tumor diameter (MTD) of the index lesion, or both, enhance the ability to predict biochemical recurrence in pT2 patients. They identified 1,657 patients using digital tumor maps and quantification of TTV/MTD who had pT2 disease on radical prostatectomy.

Personalized oligonucleotide therapy for treatment of a rare genetic disease December 2019—A variety of molecular diagnostic laboratory tools are available to diagnose diseases caused by mutations in the human genome. However, few treatments are available to correct the underlying pathophysiology driven by these mutations. This is due, in part, to pharmaceutical companies’ inability to justify, from a business perspective, the expense and time necessary to develop and obtain FDA approval for novel therapies that benefit only a small number of patients.