RE: HCV4 Aug 2021 11:58
Here's all of the section about AIHL and HCV... (the article can still be viewed if you click the link in Genedrive's twitter post, well worth reading again).
Hearing loss and HCV...
Genedrive has been developing a point-of-care test for antibiotic-related hearing loss for almost three years. Its assay, developed in partnership with the Manchester Center for Genomic Medicine, can be used to detect a genetic mutation in the MT-RNR1 gene that can cause hearing loss in some newborns who have taken gentamicin, an antibiotic prescribed for various bacterial infections. The test has a turnaround time of about 30 minutes.
Genedrive achieved a CE-IVD mark for the test, called the Genedrive MT-RNR1 kit, in 2019. Last year, the UK National Institute for Health Research Manchester Biomedical Research Centre embarked on a clinical trial of the test involving around 800 newborns from sites in Manchester and Liverpool to evaluate its implementation in an NHS setting.
Budd said that Genedrive spent most of 2020 involved in the trial to see if its test could be run while admitting an infant to the hospital without delaying the admission process. "The answer was yes," he noted. "You can get genetic information on a baby that doesn't impact admission."
A manuscript is being written at the moment, and Genedrive now plans a commercial launch of the test in the fall. Based on feedback from users, Genedrive is also improving the instrument interface to better address their needs, Budd said.
Genedrive obtained a CE-IVD mark for its hepatitis C virus assay in 2017 and partnered with Sysmex to sell the assay throughout Europe, the Middle East, Africa, and the Asia Pacific region. Last year, the World Health Organization included the assay in its list of prequalified diagnostics, making it eligible to be included in United Nations agencies' procurement processes.
Budd described the company's HCV test as its business area most impacted by the COVID-19 pandemic.
"HCV is a chronic disease. You can have it for 15 years and not have any symptoms at all," said Budd. "When the world was focusing on COVID, chronic disease was left to the side," he said.
Despite this temporary setback, Budd said sales have resumed in Africa and Asia Pacific, which he described as the primary markets for the test. "We see more activity picking up, and I think we can feel positive that it's turned around," he said.
And while the pandemic has arguably diminished HCV assay sales, Budd said that overall, there have been benefits for the molecular diagnostics industry in terms of raising its public profile.
"People are sitting on buses talking about getting PCR tests done," said Budd. "Who would have ever thought that would happen?" he said. "From an industry visibility standpoint, it's been amazing."
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