Better cancer diagnostics at core of Future of Pathology report
June 2020—Leica Biosystems launched in April The Future of Pathology Expert Report written by an international panel of pathologists in consultation with health care executives, cancer stakeholders, and pathology leaders.
In the report, each member of the panel—Tiffany Graham, MD, and Jerad Gardner, MD, in the U.S., and Bethany Williams, MBBS, PhD, and Matthew Clarke, MBBS, in the U.K.—addresses one of four subjects: pathology education, digital pathology and artificial intelligence, improving perceptions of pathology, and molecular pathology. The theme of the report (available at www.thefutureofpathology.com) is improving and transforming cancer diagnostics.
Dr. Graham, gastrointestinal and hepatobiliary/surgical pathology clinical instructor, Medical University of South Carolina, addresses how the new generation of pathologists can be trained and retained.
Dr. Williams, digital pathology research fellow at Leeds Teaching Hospitals NHS Trust and the University of Leeds, explores how digital pathology and AI can support pathologists—not replace them—and how both can be transformative. “DP and AI are a tide that raises all boats,” she writes.
Dr. Gardner, associate professor of pathology and dermatology, dermatopathology fellowship program director, and co-director of the musculoskeletal/skin module at the College of Medicine, University of Arkansas for Medical Sciences, writes about “The unseen wall: changing the perception of pathology.” The time for the wall to come down is now, he says.
“Why not leave the wall in place? Aren’t pathologists happy tucked away in our labs with our invisibility cloaks on? Actually we’re not,” he writes, “because in order to deliver the best patient care, it is increasingly important that we interact with other members of the healthcare team.”
Dr. Clarke, histopathology trainee and clinical fellow at the Institute of Cancer Research in London, makes the case for improving the provision of molecular pathology testing and how pathologists and hospital administrators can collaborate to do so. “Even as cancer numbers rise,” he writes, “patients are missing out on molecular testing and on subsequent targeted therapy.”
The Future of Pathology initiative, supported by Leica Biosystems, was launched at an event at the Royal College of Pathologists in London on International Pathology Day 2019. Its leaders say it’s a catalyst for a conversation.
“Pathology has reached a critical moment as cancer cases rise and the workforce declines,” Dr. Gardner said in an April 23 statement about the report. He added, “The time to pursue positive changes to the profession is now.”
Agilent PD-L1 assay approved as companion diagnostic
The Food and Drug Administration has approved Agilent Technologies’ PD-L1 IHC 28-8 pharmDx for expanded use in non-small cell lung cancer.
The assay will be used as an aid in identifying patients with metastatic NSCLC for treatment with the dual immunotherapy combination of Opdivo (nivolumab) and Yervoy (ipilimumab), manufactured by Bristol Myers Squibb. Based on the results of the phase three CheckMate 227 clinical trial, Opdivo in combination with Yervoy was approved as first-line treatment for patients with metastatic NSCLC whose tumors express PD-L1 (≥1 percent) as determined by an FDA-approved test.
Randox SARS-CoV-2 controls receive CE mark
Randox Laboratories’ whole pathogen molecular controls for SARS-CoV-2, unveiled in April (“Put It on the Board,” May 2020), were granted CE marking in May.
The controls are being used alongside Randox’s SARS-CoV-2 tests, performed on its Biochip, as part of a nationwide United Kingdom testing program.
FDA clears LVDS with BioMérieux culture systems
BioMérieux’s BACT/Alert BPA and BPN culture bottles received 510(k) clearance from the FDA for Large Volume Delayed Sampling of leukocyte-reduced apheresis platelets and leukocyte-reduced whole blood platelet concentrates with BACT/Alert 3D and Virtuo systems.
The FDA’s 2019 guidance recognizes LVDS as an effective strategy to control the risk of bacterial contamination in platelets and extend their shelf life to seven days with a single-step approach.
Beckman awarded expanded partnership with BARDA
Beckman Coulter was awarded an expanded partnership with the Biomedical Advance Research and Development Authority as part of BARDA’s COVID-19 medical countermeasure portfolio.
The partnership was awarded to Beckman Coulter, in collaboration with Dascena, for additional advanced research and development that will optimize a machine-learning–based sepsis diagnostic and prediction algorithm to include assessing its use with COVID-19 patients.
The sepsis diagnostic and prediction algorithm builds on Beckman Coulter’s existing Early Sepsis Indicator, which received FDA 510(k) clearance in 2019, combining the monocyte distribution width laboratory test parameter values with Dascena’s electronic health record data-based machine-learning algorithm to help accurately predict and detect those with sepsis.
“Until recently, the majority of sepsis cases have been thought to be caused by bacterial pathogens,” Shamiram R. Feinglass, MD, MPH, Beckman Coulter chief medical officer, said in a statement. “COVID-19 is changing that and causing a paradigm shift in how we think about sepsis. The aim of the study is to determine whether MDW, as part of the sepsis prediction algorithm, will be able to aid in the detection of sepsis regardless of whether it is bacterial or viral-induced.”
This COVID-19 specific study is part of BARDA’s Rapidly Deployable Capabilities program to identify and pilot near-term innovative solutions for COVID-19, leveraging the development of Beckman Coulter’s digital sepsis prediction algorithm under BARDA’s Division of Research Innovation and Venture Solving Sepsis Program.
Roche launches upgraded target enrichment solution
Roche launched its KAPA Target Enrichment portfolio, consisting of both exome and custom target enrichment solutions for sequencing.
Roche is also launching a new HyperDesign tool that enables researchers to create custom target enrichment designs that use the new KAPA HyperChoice probes. The probes are paired with a streamlined, automatable workflow.
The new KAPA HyperExome, KAPA HyperChoice, and KAPA HyperExplore probes replace the SeqCap product portfolio that will be discontinued. Roche says it will continue to support its use through the first quarter of 2022.
The KAPA HyperExome targets the GRCh38/hg38 genome assembly and covers the CCDS, RefSeq, Ensembl, Gencode, and ClinVar genomic databases in an efficient ~43 Mb capture target size.
Latest on COVID-19
Editor’s note: See captodayonline.com for up-to-the-minute news on SARS-CoV-2 tests (in “Top News”), plus COVID-19 coverage that becomes available between print issues. A comprehensive list of FDA EUAs can be found at https://j.mp/fda-eua.