iAMP® COVID-19 Detection kit, a molecular SARS-CoV-2 detection assay distributed by Fujirebio Europe, is now CE marked

Product news

Fujirebio Europe today announced that the molecular IVD assay iAMP COVID-19 Detection Kit from its partner Atila Biosystems, Inc. has been CE marked. The qualitative detection kit based on real-time fluorescent reverse transcription isothermal amplification, eliminating the need for RNA extraction, was also granted1 Emergency Use Authorization by the US Food and Drug Administration on April 10.

The iAMP COVID-19 Detection Kit can be run on a Real-Time PCR PowerGene 9600 Plus or any other qPCR automate capable of measuring fluorescence in FAM/HEX channel in real-time.

The new iAMP COVID-19 molecular assay complements the existing panel of biomarkers available on the LUMIPULSE® G System for infection (PCT, Ferritin), inflammation (IL-6) and epithelial lung injury (KL-6) to predict disease severity in patients infected with SARS-CoV-2.

Products from Atila Biosystems, Inc. are available through Fujirebio's European affiliates and through a large portion of Fujirebio's existing or new European distribution network. For further information on this press release you can contact Fujirebio on +32 9 329 17 03 or contact your Fujirebio representative or visit www.fujirebio.com/en/contact.

 

About Atila Biosystems, Inc.

Atila Biosystems, Inc. is based in Mountain View, California in the USA and since 2009, Atila Biosystems, Inc. has focused on developing novel chemistry for nucleic acid amplification and detection of clinical diagnostic applications. The team brings deep expertise in biological and chemical engineering as they develop innovative technologies with ultra-high multiplex ability, accuracy and speed. The company is at the forefront of the nucleic acid amplification field and has innovative technologies for both isothermal amplification and polymerase chain reaction.

The 3N technology is an innovative nucleic acid amplification technology that is fundamentally different from the current PCR technology design. The technology completely solves the problems associated with primer dimer and non-specific amplification and provides superior sensitivity and multiplicity to nucleic acid amplification and detection. 3N technology is compatible with all current nucleic acid amplification methods and is applicable to a wide range of biomedical research and clinical diagnosis. Atila Biosystems, Inc. has successfully applied this technology to the development of copy number variation (CNV) assays, various pathogen detection kits, and a Hotspot Cancer Panel NGS library preparation kit.

Their Omega nucleic acid amplification technology is Atila Biosystems’ patented isothermal amplification technology which allows the introduction of any artificial sequences during the amplification process. The introduced artificial sequences into the reaction system can be used for many purposes such as signal generation & reaction speed-up. Omega technology enables to detect targeted nucleic acid from raw samples directly without extraction process in extremely high multiplex isothermal real time fluorescent detection format. An example, Atila Biosystems’ AmpFire HPV Screening 16/18/HR assay enables to detect DNA from 15 high risk HPV genotypes in a single tube reaction and simultaneously genotype HPV from self-sampling dry brush swab samples directly, so does other woman’s health products such as STI, HSV, Candida, BV, etc.

 

About Fujirebio

Fujirebio is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years’ accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products.

Founded in 1950 in Tokyo, Japan, Fujirebio has over the years concluded a number of successful acquisitions of best-in-class IVD companies. Examples include Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010. Today, Fujirebio’s global presence includes offices in the United States, Latin America, Europe and Asia as well as a vast international distribution network.

Fujirebio has a strong and long-lasting tradition of collaborating with experts in the worldwide clinical community in the development of high-quality routine and truly novel biomarkers that cover a variety of disease states. Its IVD product lines span the range from specialized manual and automated testing to fully automated routine clinical laboratory testing solutions.

Fujirebio is a wholly-owned subsidiary of Miraca Holdings Inc. (listed on the Tokyo Stock Exchange – TYO: 4544) and employs more than 1.200 people in Asia, Europe and America.

 

References

  1. Limited to high-complexity CLIA-certified labs.