Roche Receives Emergency Use FDA Approval for Automated Coronavirus Test
|
By LabMedica International staff writers Posted on 24 Mar 2020 |
|
Image: cobas SARS-CoV-2 Test (Photo courtesy of Roche Holding AG)
Roche Holding AG (Basel, Switzerland) has received the US Food and Drug Administration’s (FDA) Emergency Use Authorization (EUA) for its cobas SARS-CoV-2 Test which is intended for the qualitative detection of SARS-CoV-2, the virus that causes COVID-19 disease. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are widely available in the US and around the world. The CE-IVD test is also available in markets accepting the CE mark for patients with signs and symptoms of COVID-19 disease and living in affected areas where the SARS-CoV-2 virus is known to be present.
The cobas SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. The test is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the CDC SARS-CoV-2 clinical criteria. Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours and offer improved operating efficiency, flexibility, and fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in eight hours. The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems. Upon authorization Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems.
"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO of Roche Diagnostics. “Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”
Related Links:
Roche Holding AG
The cobas SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-sarbecovirus detection for the sarbecovirus subgenus family that includes SARS-CoV-2. The test is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet the CDC SARS-CoV-2 clinical criteria. Roche’s cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 Test, provide test results in three and half hours and offer improved operating efficiency, flexibility, and fastest time-to-results with the highest throughput providing up to 96 results in about three hours and a total of 384 results for the cobas 6800 System and 960 results for the cobas 8800 System in eight hours. The test can be run simultaneously with other assays provided by Roche for use on the cobas 6800/8800 Systems. Upon authorization Roche will have millions of tests a month available for use on the cobas 6800 and 8800 systems.
"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO of Roche Diagnostics. “Over the last weeks, our emergency response teams have been working hard to bring this test to the patients. CE-mark certification and the FDA’s granting of EUA supports our commitment to give more patients access to reliable diagnostics which are crucial to combat this serious disease.”
Related Links:
Roche Holding AG
New
Gold Member
Multiplex Genetic Analyzer
MassARRAY Dx Analyzer (Europe only)
New
Chagas Disease Test
LIAISON Chagas
New
Malondialdehyde HPLC Test
Malondialdehyde in Serum/Plasma – HPLC
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants
Channels
Clinical Chemistry
view channel
AI-Powered Blood Test Accurately Detects Ovarian Cancer
Ovarian cancer ranks as the fifth leading cause of cancer-related deaths in women, largely due to late-stage diagnoses. Although over 90% of women exhibit symptoms in Stage I, only 20% are diagnosed in... Read more
Automated Decentralized cfDNA NGS Assay Identifies Alterations in Advanced Solid Tumors
Current circulating cell-free DNA (cfDNA) assays are typically centralized, requiring specialized handling and transportation of samples. Introducing a flexible, decentralized sequencing system at the... Read more
Mass Spectrometry Detects Bacteria Without Time-Consuming Isolation and Multiplication
Speed and accuracy are essential when diagnosing diseases. Traditionally, diagnosing bacterial infections involves the labor-intensive process of isolating pathogens and cultivating bacterial cultures,... Read more
First Comprehensive Syphilis Test to Definitively Diagnose Active Infection In 10 Minutes
In the United States, syphilis cases have surged by nearly 80% from 2018 to 2023, with 209,253 cases recorded in the most recent year of data. Syphilis, which can be transmitted sexually or from mother... Read moreMolecular Diagnostics
view channel
Groundbreaking Molecular Diagnostic Test Accurately Diagnoses Major Genetic Cause of COPD
Chronic obstructive pulmonary disease (COPD) and Alpha-1 Antitrypsin Deficiency (AATD) are both conditions that can cause breathing difficulties, but they differ in their origins and inheritance.... Read more
First-in-Class Diagnostic Blood Test Detects Axial Spondyloarthritis
Axial spondyloarthritis (axSpA) is a chronic inflammatory autoimmune condition that typically affects individuals during their most productive years, with symptoms often emerging before the age of 45.... Read more
New Molecular Label to Help Develop Simpler and Faster Tuberculosis Tests
Tuberculosis (TB), the deadliest infectious disease globally, is responsible for infecting an estimated 10 million people each year and causing over 1 million deaths annually. While chest X-rays and molecular... Read more
Biomarker Discovery Paves Way for Blood Tests to Detect and Treat Osteoarthritis
The number of individuals affected by osteoarthritis is projected to exceed 1 billion by 2050. The primary risk factor for this common, often painful chronic joint condition is aging, and, like aging itself,... Read moreHematology
view channel
First Point-of-Care Heparin Monitoring Test Provides Results in Under 15 Minutes
Heparin dosing requires careful management to avoid both bleeding and clotting complications. In high-risk situations like extracorporeal membrane oxygenation (ECMO), mortality rates can reach about 50%,... Read more
New Scoring System Predicts Risk of Developing Cancer from Common Blood Disorder
Clonal cytopenia of undetermined significance (CCUS) is a blood disorder commonly found in older adults, characterized by mutations in blood cells and a low blood count, but without any obvious cause or... Read more
Immunology
view channel
Stem Cell Test Predicts Treatment Outcome for Patients with Platinum-Resistant Ovarian Cancer
Epithelial ovarian cancer frequently responds to chemotherapy initially, but eventually, the tumor develops resistance to the therapy, leading to regrowth. This resistance is partially due to the activation... Read more
Machine Learning-Enabled Blood Test Predicts Immunotherapy Response in Lymphoma Patients
Chimeric antigen receptor (CAR) T-cell therapy has emerged as one of the most promising recent developments in the treatment of blood cancers. However, over half of non-Hodgkin lymphoma (NHL) patients... Read more
Microbiology
view channel
Molecular Stool Test Shows Potential for Diagnosing TB in Adults with HIV
Tuberculosis (TB), caused by the bacterium Mycobacterium tuberculosis, led to 1.25 million deaths in 2023, with 13% of those occurring in people living with HIV. The current primary diagnostic method for... Read more
New Test Diagnoses Bacterial Meningitis Quickly and Accurately
Bacterial meningitis is a potentially fatal condition, with one in six patients dying and half of the survivors experiencing lasting symptoms. Therefore, rapid diagnosis and treatment are critical.... Read more
Pathology
view channel
Groundbreaking Chest Pain Triage Algorithm to Transform Cardiac Care
Cardiovascular disease is responsible for a third of all deaths worldwide, and chest pain is the second most common reason for emergency department (ED) visits. With EDs often being some of the busiest... Read more
AI-Based Liquid Biopsy Approach to Revolutionize Brain Cancer Detection
Detecting brain cancers remains extremely challenging, with many patients only receiving a diagnosis at later stages after symptoms like headaches, seizures, or cognitive issues appear. Late-stage diagnoses... Read more
Technology
view channel
Advanced Predictive Algorithms Identify Patients Having Undiagnosed Cancer
Two newly developed advanced predictive algorithms leverage a person’s health conditions and basic blood test results to accurately predict the likelihood of having an undiagnosed cancer, including ch... Read more
Light Signature Algorithm to Enable Faster and More Precise Medical Diagnoses
Every material or molecule interacts with light in a unique way, creating a distinct pattern, much like a fingerprint. Optical spectroscopy, which involves shining a laser on a material and observing how... Read more
Disposable Microchip Technology Could Selectively Detect HIV in Whole Blood Samples
As of the end of 2023, approximately 40 million people globally were living with HIV, and around 630,000 individuals died from AIDS-related illnesses that same year. Despite a substantial decline in deaths... Read more
Pain-On-A-Chip Microfluidic Device Determines Types of Chronic Pain from Blood Samples
Chronic pain is a widespread condition that remains difficult to manage, and existing clinical methods for its treatment rely largely on self-reporting, which can be subjective and especially problematic... Read moreIndustry
view channel
Cepheid and Oxford Nanopore Technologies Partner on Advancing Automated Sequencing-Based Solutions
Cepheid (Sunnyvale, CA, USA), a leading molecular diagnostics company, and Oxford Nanopore Technologies (Oxford, UK), the company behind a new generation of sequencing-based molecular analysis technologies,... Read more
Grifols and Tecan’s IBL Collaborate on Advanced Biomarker Panels
Grifols (Barcelona, Spain), one of the world’s leading producers of plasma-derived medicines and innovative diagnostic solutions, is expanding its offer in clinical diagnostics through a strategic partnership... Read more
