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. The workflow also offers clear sample traceability, with LIS integration and connectivity, Vela said in the statement.
The system generates a clinical interpretation report that provides information on drug resistances associated with the detected mutations, using a standalone version of the curated Stanford University HIV Drug Resistance Database to ensure traceability of the drug resistance mutations report.
Compared with Sanger bidirectional sequencing and other nonautomated NGS alternatives, Vela says, the Sentosa SQ HIV-1 Genotyping Assay using the Sentosa NGS workflow is highly sensitive and delivers clinically relevant results with reduced hands-on time (less than two hours combined) and turnaround time (two days).
In 2017, an earlier version of the Sentosa SQ HIV Genotyping Assay received the CE mark and was approved by the Australian Therapeutic Goods Administration and Singapore Health Sciences Authority. In August 2019, the assay received approval from the Thai FDA. The current configuration of the assay is pending review for the CE mark and from the Singapore HSA.
Paige announces CE mark for prostate AI solution
Paige announced on Nov. 12 the CE mark for Paige Prostate, along with Paige Insight, its AI-native digital pathology viewer, both for primary diagnosis. These solutions will now be available to European pathology practices.
Paige said in a Nov. 12 statement that Insight allows pathologists to view, process, and collaborate on whole digitized slides from different sites and scanners while leveraging the power of Paige’s AI-based modules. The first such module, Paige Prostate, “has achieved clinical grade accuracy,” according to the company, “demonstrating equivalent performance in images taken with multiple scanners and on slides prepared at hundreds of institutions.”
Paige said it found, in a usability study of Paige Prostate and the Insight viewer, that the technology proved most impactful in the detection of small, well-differentiated foci of cancer.
Leica launches ‘Future of Pathology’ initiative
Leica Biosystems launched on Nov. 13 “The Future of Pathology”—the catalyst for a conversation that brings together pathologists, hospital administrators, and others to discuss the goal of improving cancer diagnostics.
The Future of Pathology will identify the challenges, opportunities, and trends pathologists and other providers face in improving and transforming cancer diagnostics.
A panel that will lead the initiative has identified four priority areas:
- How can we raise the profile and improve the perception of pathology?
- How do we train and retain the new generation of pathologists?
- How can we use technology to improve cancer diagnostics?
- How can we use molecular pathology to unlock the accessibility of personalized medicine?
Members of the panel in the UK are Matthew Clarke, MBBS, clinical fellow, Institute of Cancer Research, and Bethany Williams, MBBS, PhD, digital pathology research fellow, Leeds Teaching Hospitals NHS Trust and the University of Leeds. In the U.S., the members are Jerad Gardner, MD, associate professor of pathology and dermatology, University of Arkansas for Medical Sciences, and Tiffany Graham, MD, gastrointestinal and hepatobiliary/surgical pathology clinical instructor, Medical University of South Carolina. They will explore the issues and themes through interviews with C-suite executives, cancer stakeholders, and pathology leaders, and share their perspectives and insights through blogs, articles, and a report to be available early in 2020.
Visit www.FutureOfPathology.com or Tweet @LeicaBio and use the hashtag #FutureofPathology to be part of the conversation.
Inflammatix to receive BARDA funding
Molecular diagnostics company Inflammatix announced Nov. 14 an agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, to further develop its HostDx tests. Inflammatix will receive $6 million in the first phase of a cost-sharing contract worth up to $72 million based on achieving milestones.
The contract will advance development and commercialization of Inflammatix’s point-of-care HostDx test system, which will produce results in under 30 minutes. The first phase of work will focus on the HostDx Fever test, which reads gene expression patterns in the immune system to identify whether a suspected infection is bacterial or viral.
The contract may optionally support two other Inflammatix tests: HostDx Sepsis and HostDx FeverFlu. HostDx Sepsis measures the expression of multiple immune genes to determine if the patient has a bacterial or viral infection and whether the patient has or is likely to develop sepsis. HostDx FeverFlu will be performed on nasal swab samples and combine traditional influenza testing with host-response biomarkers.
Inflammatix received in August the AACC’s Disruptive Technology Award for its HostDx tests, based on the company’s presentation during the AACC annual meeting. It was one of three finalists selected to present to a panel of expert judges.