A highly accurate new tool for the direct detection of HPV mRNA
in FFPE tissue specimens
MINNEAPOLIS, July 6, 2022
/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
European launch of the CE-IVD marked RNAscope ISH Probe High Risk
HPV, intended for use in patients diagnosed with oropharyngeal
squamous cell carcinoma (OPSCC) to aid in the identification of
high-risk human papillomavirus (HPV).
HPV is a major cause of OPSCC, and HPV has emerged as a valuable
diagnostic marker that significantly impacts clinical
management.1,2 Immunohistochemistry (IHC) for p16
protein, a surrogate marker, is widely used for HPV detection in
OPSCC; however, misdiagnosis rates of 5‑20% have been reported when
using p16.3 The presence of E6/E7 mRNA is considered the
gold standard for diagnosing HPV-related OPSCC.4
RNAscope offers a superior method for detection of E6/E7 mRNA when
assessing HPV status in OPSCC patients, enabling clinicians to
provide a more accurate diagnosis and improve patient
management.5
"Bio-Techne's innovative tissue diagnostic solutions empower our
customers to serve patients and improve lives," said Kim Kelderman, President, Diagnostics and
Genomics Segment of Bio-Techne. "We are excited to launch the new
CE-IVD RNAscope ISH Probe High Risk HPV, which provides
pathologists a highly accurate tool for the direct detection of HPV
mRNA to inform treatment selection in oropharyngeal squamous cell
carcinoma patients."
RNAscope in situ hybridization (ISH) is a highly
sensitive and specific spatial biology technology. Its double Z
probe design enables an exceptional signal-to-noise ratio when
staining formalin-fixed paraffin-embedded (FFPE) tissue specimens.
RNAscope ISH allows users to visualize and localize biomarker
expression patterns by light microscopy. Over the past 10 years,
RNAscope ISH has proven its reliability, reproducibility, and
robustness with more than 6000 peer reviewed publications, making
it a powerful solution for anatomic pathologists.
RNAscope ISH Probe High Risk HPV is used in an RNAscope ISH
assay for the qualitative detection of HPV E6/E7 mRNA in FFPE
tissue specimens. RNAscope ISH Probe High Risk HPV is for use in
clinical laboratories with the CE-IVD marked BOND RNAscope Brown
Detection kit on the automated Leica Biosystems BOND-III stainer.
The assay detects high-risk HPV types 16, 18, 26, 31, 33, 35, 39,
45, 51, 52, 53, 56, 58, 59, 66, 68, 73, and 82.
To learn more about RNAscope ISH Probe High Risk HPV, please
visit www.bio-techne.com/rnascope-hpv
About Bio-Techne Corporation (NASDAQ: TECH)
Contact:
|
David Clair, Senior
Director, Investor Relations and Corporate Development
david.clair@bio-techne.com
612-656-4416
|
References
- Craig SG, Anderson LA, Schache AG, Moran M, Graham L, Currie K,
Rooney K, Robinson M, Upile NS, Brooker R, Mesri M, Bingham V,
McQuaid S, Jones T, McCance DJ, Salto-Tellez M, McDade SS, James
JA. Recommendations for determining HPV status in patients with
oropharyngeal cancers under TNM8 guidelines: a two-tier approach.
Br J Cancer. 2019 Apr;120(8):827-833.
- Lewis JS Jr, Beadle B, et al. Human Papillomavirus Testing in
Head and Neck Carcinomas: Guideline from the College of American
Pathologists. Arch Pathol Lab Med. 2018 May;142(5):559-597.
- Huanhuan W, Yuyu Z, Wei B, et al. Feasibility of
immunohistochemical p16 staining in the diagnosis of human
papillomavirus infection in patients with squamous cell carcinoma
of the head and neck: a systematic review and meta-analysis. Front
Oncol. 2020;10:524928.
- Bussu F, Ragin C, Boscolo-Rizzo P, Rizzo D, Gallus R, Delogu G,
Morbini P, Tommasino M. HPV as a marker for molecular
characterization in head and neck oncology: Looking for a
standardization of clinical use and of detection method(s) in
clinical practice. Head Neck. 2019 Apr;41(4):1104-1111.
- Bishop JA, Ma XJ, Wang H, Luo Y, Illei PB, Begum S, Taube JM,
Koch WM, Westra WH. Detection of transcriptionally active high-risk
HPV in patients with head and neck squamous cell carcinoma as
visualized by a novel E6/E7 mRNA in situ hybridization method. Am J
Surg Pathol. 2012 Dec;36(12):1874-82.
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SOURCE Bio-Techne Corporation