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BIO-TECHNE ANNOUNCES LAUNCH OF KAPPA AND LAMBDA RNAscope ISH PROBES AS ANALYTE SPECIFIC REAGENTS (ASRs) FOR THE DETECTION OF IMMUNOGLOBULIN KAPPA AND LAMBDA LIGHT CHAINS mRNA Bio-Techne (NASDAQ: TECH), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic...

Key Takeaway: Bio-Techne announced the launch of two new RNAscope in situ Hybridization Probes, Kappa and Lambda, aimed at detecting immunoglobulin kappa and lambda light chains mRNA in B-cells. These probes are intended to enhance the identification of monoclonal B-cell populations, which are often linked to malignancies. Designed as analyte specific reagents (ASRs), they support the development of laboratory tests while ensuring regulatory compliance and accuracy. The introduction of these tools reflects Bio-Techne's commitment to innovation in the diagnostic field.
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POSITIVE FACTORS

  • Launch of RNAscope ISH Probes for kappa and lambda light chains mRNA is significant in oncology.
  • These ASRs enhance the accuracy and reliability of tests for B-cell clonality.
  • Bio-Techne is committed to innovative solutions to improve patient outcomes.

Full Press Release Details

MINNEAPOLIS , May 10, 2023 /PRNewswire/ -- Bio-Techne (NASDAQ: TECH ), a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities today announced the launch of two new RNAscope™ in situ Hybridization Probes Kappa and Lambda as analyte specific reagents (ASRs) for the detection of immunoglobulin kappa and lambda light chains mRNA in B-cells.
Detection of B-cell clonality is useful for identification of monoclonal B-cell populations which are often associated with a malignancy. Immunoglobulin kappa and lambda chains are important biomarkers for the assessment of B-cell clonality. Flow cytometry is the current gold standard for assessing kappa and lambda light chains, but it may not be effective for certain B-cell lymphomas that lack surface immunoglobulin expression. In such cases, formalin-fixed, paraffin-embedded (FFPE) tissues are required, but methods such as immunohistochemistry (IHC) may not be sensitive enough to detect light chain expression in B-cells. RNAscope ISH Probes Kappa and Lambda are designed to detect immunoglobulin kappa and lambda light chains mRNA. RNAscope probes are visualized with the highly sensitive RNAscope ISH detection reagents, which are compatible with FFPE tissue.
ASRs are critical building blocks for Laboratory Developed Tests (LDTs) and play a key role in ensuring the accuracy and reliability of test results. By using ASRs, CLIA labs can develop customized tests that are tailored to the specific needs of their patient population, while maintaining high standards of analytical and clinical performance. This allows for greater flexibility and innovation in the development of new tests, while ensuring that they meet the regulatory requirements for accuracy and reliability.
"We are excited to expand our ASR probe menu with the launch of RNAscope ISH Probes Kappa and Lambda, as these are important oncology biomarkers," said Kim Kelderman , President, Diagnostics and Genomics. "We are committed to enabling our customers with Bio-Techne's innovative spatial biology solutions to serve patients and improve lives."
ACD, a Bio-Techne Brand , is proud to be certified to ISO 13485:2016 standard. ASR probes are manufactured in compliance with GMP requirements to ensure product quality.
About Bio-Techne Bio-Techne Corporation ( NASDAQ : TECH) is a global life sciences company providing innovative tools and bioactive reagents for the research and clinical diagnostic communities. Bio-Techne products assist scientific investigations into biological processes and the nature and progress of specific diseases. They aid in drug discovery efforts and provide the means for accurate clinical tests and diagnoses. With thousands of products in its portfolio, Bio-Techne generated approximately $1.1 billion in net sales in fiscal 2022 and has approximately 3,000 employees worldwide. For more information on Bio-Techne and its brands, please visit https://www.bio-techne.com or follow the Company on social media at: Facebook , LinkedIn , Twitter or YouTube .

Frequently Asked Questions

What are RNAscope™ Probes Kappa and Lambda?

They are analyte specific reagents for detecting mRNA of immunoglobulin kappa and lambda light chains in B-cells.

Why are kappa and lambda chains important?

They are vital biomarkers for assessing B-cell clonality, often linked to malignancies.

What challenges does flow cytometry face?

It may be ineffective for some B-cell lymphomas that lack surface immunoglobulin expression.

How do RNAscope probes enhance detection?

They offer improved sensitivity for mRNA detection in formalin-fixed, paraffin-embedded tissues.

What standards do Bio-Techne ASR probes meet?

They are manufactured under GMP and certified to the ISO 13485:2016 standard.

Last updated: May 10, 2023