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MedTech Outlook | Tuesday, June 14, 2022
The recent novel coronavirus, responsible for over 100 deaths in the Hubei province in China at the time of writing, undermines any notion of a known quantity of infectious disease threats in the world that lab analyzer menus will remain adequate.
FREMONT, CA: According to IVD market research firm Kalorama Information, the recent novel coronavirus, which has caused over 100 deaths in China's Hubei province at the time of writing, undermines any notion of a known quantity of infectious disease threats in the world that lab analyzer menus will remain adequate. Swine flu, Ebola, and Zika have all served as reminders that laboratories must remain attentive and that in vitro diagnostic test manufacturers must regularly update assays that providers can utilise to identify dangers. The virus has been characterised and identified using diagnostic technologies such as reverse transcription-polymerase chain reaction (RT-PCR) and sequencers, and additional procedures are being developed. Vendors of IVDs are assisting in the endeavour. Meridian Bioscience reported that its Lyo-Ready 1-Step RT q-PCR mix, which is freeze-dried, is being employed in China's coronavirus outbreak. According to Kalorama Information's latest complete globe infectious illness market research report, the infectious disease IVD testing industry will be worth more than USD 18 billion, with revenue growth above the four per cent of normal testing markets.
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The new virus, called 2019-nCoV, has already been sequenced, and Chinese health officials have shared the entire genome on the GISAID (Global Initiative on Sharing All Influenza Data) portal, which collects data on respiratory infections. Other researchers were able to quickly detect the virus's RNA processes and build new detection methods as a result of this. The US government will make decisions based on this information. The Centers for Disease Control and Prevention (CDC) has created its own real-time polymerase chain reaction (PCR) test. The new betacoronavirus belongs to the same virus family as the severe acute respiratory syndrome (SARS-CoV) and the Middle East respiratory sickness (MERS-CoV), both of which are caused by bats. The coronavirus gets its name from the virus's crown-shaped appearance under electron microscopy, and the shape appears to be an important aspect. The extensively glycosylated spike protein is thought to aid the virus's propagation by allowing it to merge with host cell membranes. The only U.S. facility identified to complete virus isolation and perform real-time PCR to diagnose 2019-nCoV was the CDC laboratory in Atlanta at the time of writing; however, the agency has distributed test methods and aims to make reagents available. The CDC recommends collecting sputum, nasopharyngeal swabs, and blood in cases of probable coronavirus in patients who have recently travelled to impacted areas.
Commercially available testing kits for 2019-nCoV are not currently available. Altona Diagnostics spoke on January 23 that it was working on a molecular diagnostic assay for identifying 2019-nCoV in collaboration with key emerging disease reference institutes. During epidemics of SARS-CoV, MERS-CoV, Ebola, and Zika viruses, among others, Altona Diagnostics was one of the first companies to commercialise effective molecular diagnostic kits. In addition, Co-Diagnostics, a molecular diagnostics company, reported a few days ago that it had finished design work on a PCR screening test for the new virus. In the wake of Ebola and Zika, IVD companies will constantly be working to adjust test technologies and design tests for emergency approval. Roche and Chembio Diagnostic Systems were two of the companies that developed Ebola emergency use authorisation (EUA) tests. Siemens Fast Track, Seegene Anyplex, Roche LightMix, and Bio-Rad CFX96 are among the coronavirus MERS tests available, and the manufacturers are well-positioned to adapt their technology for similar new viruses. In a recent podcast, Abbott Laboratories stated that it is closely following the 2019-nCoV outbreak.
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