Bruker Expects its FluoroType® SARS-CoV-2 varID Q PCR Assay to Reliably Detect and Tentatively Differentiate Omicron (B.1.1.529) Variant

Rhea-AI Summary

Bruker Corporation (Nasdaq: BRKR) announced its CE-IVD marked FluoroType^® SARS-CoV-2 varID Q PCR assay, capable of detecting all major variants of SARS-CoV-2, including Omicron (B.1.1.529). The assay identifies key S-gene mutations associated with Omicron and provides viral load results in less than 4 hours. It is validated for use with the FluoroCycler^® XT thermocycler and supports automated extraction via the GenoXtract^® fleXT system. Bruker’s other SARS-CoV-2 assays are also expected to detect the Omicron variant.

Positive

• Launch of the FluoroType^® SARS-CoV-2 varID Q assay enhances detection capabilities for all SARS-CoV-2 variants.
• The capability to detect Omicron mutations may lead to increased demand for testing.
• The assay provides rapid results (under 4 hours), which is beneficial for timely decision-making in clinical settings.

Negative

• None.

• Includes robust dual-target SARS-CoV-2 detection and identification of 4 S-gene mutations
• Reliable detection and even tentative differentiation of Omicron variant expected
• Validated with the GenoXtract^® and GenoXtract ^® fleXT extraction system
• Validated with Bruker’s novel FluoroCycler^® XT real-time PCR thermocycler

NEHREN, Germany--(BUSINESS WIRE)-- Bruker Corporation (Nasdaq: BRKR) today announced that its established CE-IVD marked FluoroType^® SARS-CoV-2 varID Q real-time multiplexed PCR assay reliably detects all SARS-CoV-2 variants, and in addition is expected to also provide a clear indication of Omicron (B.1.1.529), recently declared a ‘variant of concern’ by the WHO.

FluoroType® SARS-CoV-2 varID Q PCR Kit (Photo: Business Wire)

FluoroType^® SARS-CoV-2 varID Q is a multiplexed CE-IVD marked PCR assay for the detection and quantification of all major SARS-CoV-2 variants, based on Bruker´s proprietary LiquidArray^® technology. In addition, the assay simultaneously detects the S-gene mutations Del69-70 and N501Y, which are expected to be clear indications that the variant is Omicron (B.1.1.529). The new Omicron variant shares these mutations with the Alpha variant (B.1.1.7), but the Alpha variant is meanwhile of low epidemiological interest and only gets detected sporadically. Accordingly, by identifying Del69-70 and N501Y, the laboratory has an indication that the sample most probably is the SARS-CoV-2 Omicron variant. This can subsequently be confirmed by genomic sequencing, as is standard practice.

The FluoroType^® SARS-CoV-2 varID Q also provides a viral load result according to WHO standard (IU/ml), as well as CP values and easy interpretation of mutations. The test is validated for use with nasopharyngeal and oropharyngeal swabs and contains reagents for 96 reactions. Sample extraction, amplification and PCR results are available in under 3-4 hours.

FluoroType^® SARS-CoV-2 varID Q can be run on the FluoroCycler^® XT PCR instrument after sample preparation with the GenoXtract^® fleXT system, which provides fully automated extraction and PCR set up. The results from the FluoroCycler^® XT are analysed by the FluoroSoftware^® delivering easy to read results and direct indication of mutations.

Using the FluoroType^® SARS-CoV-2 varID Q assay allows the user to run a screening tool for detecting SARS-CoV-2, viral load and an early indication of the Omicron variant.

Moreover, Bruker is pleased to confirm that their full range of other FluoroType^® SARS-CoV-2 assays are also expected to reliably detect the Omicron variant (B.1.1.529). These assays include:

CE-IVD assays:
FluoroType^® SARS-CoV-2 plus*
FluoroType^® SARS-CoV-2 varID Q*
FluoroType^® SARS-CoV-2/Flu/RSV*

RUO assay:
FluoroType^® SARS-CoV-2 evo (RUO)* **

* Not for Sale in the USA
** Not for use in clinical diagnostics procedures

All our SARS-CoV-2 assays are CE-IVD-labeled according to the European IVD Directive 98/79/EC and mainly sold into European Markets. FluoroType^® SARS-CoV-2 plus is also registered and sold in some African markets including South Africa.

About Bruker Molecular Diagnostics

Bruker Molecular Diagnostics (MDx) is focused on MDx products within Bruker´s Microbiology & Diagnostics Business Area. Hain Lifescience GmbH is the legal manufacturer of the FluoroCycler^® XT, MTBDR 2.0 assay, GXT nucleic acid preparation kits and of the FluoroType^® SARS-CoV-2 assays. For more information: www.hain-lifescience.de.

About Bruker Corporation (Nasdaq: BRKR)

Bruker is enabling scientists to make breakthrough discoveries and develop new applications that improve the quality of human life. Bruker’s high-performance scientific instruments and high-value analytical and diagnostic solutions enable scientists to explore life and materials at molecular, cellular and microscopic levels. In close cooperation with our customers, Bruker is enabling innovation, improved productivity and customer success in life science molecular research, in applied and pharma applications, in microscopy and nanoanalysis, and in industrial applications, as well as in cell biology, preclinical imaging, clinical phenomics and proteomics research and clinical microbiology. For more information, please visit: www.bruker.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211202005759/en/

Investor:

T: +1 (978) 663–3660, ext. 1479

E: investor.relations@bruker.com

Media and Customers:

Philip Perry, Bruker Daltonics Microbiology & Diagnostics

T: +49-172-313-7216

E: Philip.Perry@bruker.com

Source: Bruker Corporation

FAQ

What is the new product launched by Bruker Corporation?

Bruker Corporation launched the FluoroType^® SARS-CoV-2 varID Q PCR assay.

How does the FluoroType SARS-CoV-2 varID Q assay identify the Omicron variant?

The assay detects specific S-gene mutations, Del69-70 and N501Y, indicating the presence of the Omicron variant.

What is the expected outcome of using the FluoroType SARS-CoV-2 varID Q assay?

The assay is expected to reliably detect all SARS-CoV-2 variants, including Omicron, within 3-4 hours.

Can the FluoroType SARS-CoV-2 varID Q assay differentiate between variants?

Yes, it provides reliable detection and differentiation of SARS-CoV-2 variants, including Omicron.

What equipment is needed to run the FluoroType SARS-CoV-2 varID Q assay?

The assay requires the FluoroCycler^® XT for amplification and the GenoXtract^® fleXT system for sample preparation.