Medical device and MedTech insights, news, tips and more
ZEUS Scientific Announces New Rapid SARS-CoV-2 Antibody Test
April 22, 2020
ZEUS Scientific announces today the submission for an Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for its rapid, in vitro diagnostic test for the qualitative detection of IgG and/or IgM antibodies to the SARS-CoV-2 (novel 2019 Coronavirus).
ZEUS’s lateral flow test uses patient serum, plasma or whole blood and provides results in 15 minutes. Assay performance has been confirmed by testing sample cohorts from healthy donors, confirmed positive COVID-19 patients and cross-reactive samples acquired from heavily afflicted regions in both China and the United States. The request for EUA is under review by the FDA and if received ZEUS expects to have the test available to ship to customers in early May 2020.
Rapid detection of cases and contacts, appropriate clinical management, infection control, and community mitigation efforts are critical to respond effectively to the COVID-19 pandemic. Results from the ZEUS test will help address the urgent health concerns surrounding the public health threat posed by COVID-19. Identifying individuals with specific antibodies to the SARS-CoV-2 virus provides valuable diagnostic information relating to previous exposure to the SARS-CoV-2 virus.
ZEUS Scientific is a trusted partner with over 40 years of in vitro diagnostic experience providing high-quality diagnostic solutions. Our New Jersey-based, FDA-inspected manufacturing facility is certified and audited to ISO 13485 (2016), FDA Quality System Regulations (1996: 21 CFR § 820) and IVD 98/79/EEC. In these difficult times you can count on ZEUS to apply our expertise and assist in the fight against COVID-19.
In addition to this rapid in vitro diagnostic test, ZEUS is also pleased to announce development of a corresponding ELISA test system, also for detection of antibodies to SARS-CoV-2. Further updates in conjunction with this higher throughput, automatable option will be provided in the near future.
See Full Press Release: ZEUS Scientific Announces New Rapid SARS-CoV-2 Antibody Test
Written by: ZEUS Scientific
Legacy MedSearch has more than 30 years of combined experience recruiting in the medical device industry. We pride ourselves on our professionalism and ability to communicate quickly and honestly with all parties in the hiring process. Our clients include both blue-chip companies and innovative startups within the MedTech space. Over the past 10 years, we have built one of the strongest networks of device professionals ranging from sales, marketing, research & , quality & regulatory, project management, field service, and clinical affairs.
We offer a variety of different solutions for hiring managers depending on the scope and scale of each individual search. We craft a personalized solution for each client and position with a focus on attracting the best possible talent in the shortest possible time frame.
Are you hiring?
Contact us to discuss partnering with Legacy MedSearch on your position.