Clinical research registry aims to answer crucial COVID-19 questions
May 2020—A Healthcare Worker Exposure Response and Outcomes Registry was launched April 13 to unite health care workers in the U.S. for rapid-cycle research.
The goals of the so-called HERO registry are to engage workers in a research community, understand their experiences, and track outcomes associated with caring for patients with COVID-19.
The HERO research program, led by Duke Clinical Research Institute, part of Duke University School of Medicine, leverages the National Patient-Centered Clinical Research Network, known as PCORnet, and is funded by the Patient-Centered Outcomes Research Institute, or PCORI.
Anyone who works in a setting in which people receive health care is being invited to join the registry. Enrollees will receive surveys, information about participating in studies, and learnings from the HERO research community, and they can participate as much or as little as they wish. The registry will follow a protocol developed by Duke Clinical Research Institute and data guidelines to keep worker information secure.
To learn more about the registry, visit https://heroesresearch.org.
Randox unveils whole pathogen molecular controls for SARS-CoV-2
Whole pathogen quality controls developed in the UK to support accurate coronavirus testing are available from Randox Laboratories.
Alongside Randox’s Coronavirus Biochip, which includes tests for SARS-CoV-2 and nine other respiratory viruses, the third-party quality controls are used to ensure accurate coronavirus test and system performance. They’re available under the brand name Qnostics.
The controls, which contain the entire SARS-CoV-2 genome, including the conserved regions recommended by the CDC and WHO, are compatible for use with commercial and in-house testing methods and are quantified by digital PCR to ensure batch-to-batch reproducibility. They are heat-inactivated to be noninfectious and are manufactured to ISO 13485 standards.
Asuragen develops Armored RNA Quant SARS-CoV-2 control
Asuragen has made available an Armored RNA Quant SARS-CoV-2 control for use in developing assays in response to the COVID-19 pandemic. The control targets the SARS-CoV-2 viral nucleocapsid (N) region and, along with the company’s new RNAse P construct, aligns with the CDC- and WHO-recommended diagnostic panel (CDC-006-00019). Armored technology encapsulates the in vitro transcribed RNA in a protective protein coat to resist nuclease degradation.
Stat Profile Prime Plus cleared for POC use
The Food and Drug Administration cleared Nova Biomedical’s Stat Profile Prime Plus critical care blood gas analyzer for point-of-care use.
The Prime Plus MicroSensor Card provides a critical care panel that includes pH, PCO2, PO2, SO2%, Na, K, Cl, iCa, iMg, glucose, lactate, urea, creatinine, Hct, Hb, O2Hb, COHb, MetHb, and HHb and requires a 60-μL minimum sample volume.
A safety sample port allows for easy docking and hands-free sampling, and the Clot Block sample flow path protects sensors from blood clot blockages and related downtime.
In other news from Nova Biomedical, PT/INR testing was added to its Allegro capillary blood analyzer for POC testing in primary care settings. The Allegro analyzer and the new PT/INR test are available for purchase in CE-regulated countries.
FDA OKs Cobas HPV test for use on 6800/8800
The Food and Drug Administration approved the Roche Cobas HPV test for use on the Cobas 6800/8800 systems. The test identifies women at risk for cervical cancer by detecting the presence of high-risk HPV DNA in cervical samples.
The FDA considered data from the registrational IMPACT (Improving Primary Screening and Colposcopy Triage) trial, which enrolled almost 35,000 women in the U.S. to clinically validate Cobas HPV for use on the 6800/8800 systems. The Cobas HPV test was approved previously for the Cobas 4800.
Therascreen BRAF test launched as companion Dx
Qiagen launched its Therascreen BRAF V600E RGQ PCR Kit after the Food and Drug Administration approved it as a companion diagnostic to the BRAF inhibitor Braftovi (encorafenib).
The FDA approved the inhibitor for use in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
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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.