Creative Biolabs Drives SARS-CoV-2 IVD Development For Earlier FDA Approval
New York, United States – July 27, 2022 /MarketersMEDIA/ —
The FDA recently reopens pre-submissions for all in vitro diagnostic (IVD) tests, including non-COVID IVD pre-submissions. This encourages companies and research institutes laggard in developing SARS-CoV-2 IVD reagents and tests to accelerate the R & D progress for forthwith premarket or emergency use authorization at the earliest opportunity. Creative Biolabs, with a proprietary in vitro diagnostic reagent development platform, announces to offer full support for SARS-CoV-2 reagent, assays, and vaccine development to drive the detection and control of SARS-CoV-2.
Reliable SARS-CoV-2 IVD solutions at Creative Biolabs make it possible for public health agencies to better control the ongoing COVID-19 pandemic, and for pharmaceuticals and medical device companies to take one step ahead of others in requesting FDA’s premarket or emergency use approval, given the elevated pandemic workload.
With increasing needs for SARS-CoV-2 diagnostics, sensitive and specific SARS-CoV-2 IVD reagents, including antibodies/antigens, are of vital importance for developing diagnostic assays and in vitro diagnostic kits on a large scale. Creative Biolabs launches a comprehensive SARS-CoV-2 IVD reagent development platform, which is eligible to provide SARS-CoV-2 IVD reagent development services for design, development, validation, and manufacturing of related immunoassays as well molecular diagnostic assays and kits.
Molecular diagnostic assays and kits based on various molecular technologies, RT-PCR technology, in particular, play a key part in detecting SARS-CoV-2 for early diagnosis. Ranging from molecular diagnostic test systems to new ready-to-use kits for IVD purposes, Creative Biolabs covers full molecular diagnostic assay development services for SARS-CoV-2 detection, including the development and validation of RT-PCR SARS-CoV-2 detection service and RT-LAMP SARS-CoV-2 detection service.
Besides diagnostic solutions, Creative Biolabs is also an active participant in SARS-CoV-2 antiviral drug discovery. A scientist at this company added, “The spike protein is important to induce neutralizing antibody, T cell responses, and protective immunity during infection with SARS-CoV-2. So we think successful expression and purification of the spike proteins are the basis for follow-up research and development work. So we also initially established several stable SARS-CoV-2 spike-expressing cell lines for vaccine and therapeutics development.”
About Creative Biolabs
Ever since the MERS epidemic in 2012, Creative Biolabs has been world-renowned for its role in helping medical device companies, laboratories, pharmaceutical companies, research institutes, and public health agencies design, develop, validate, and manufacture necessary vaccines, diagnostics, and antivirals against coronavirus pneumonia. And now, its one-stop CRO services for SARS-CoV-2 diagnosis and treatment once again contribute to improving the control of COVID-19.
Contact Info:
Name: Candy Swift
Email: Send Email
Organization: Creative Biolabs
Website: https://sars-cov-2.creative-biolabs.com/
Release ID: 89079039
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