BD's expanded genotype HPV test gets FDA nod

LabPulse.com staff writers
Jul 22, 2020
2020 07 22 22 14 9137 Bd Onclarity 400

The U.S. Food and Drug Administration (FDA) has approved an HPV test from Becton Dickinson (BD) that offers expanded genotype detection.

The BD Onclarity HPV assay individually identifies and reports genotypes beyond 16, 18, and 45. It also identifies and reports on genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66, according to the company.

Research has shown that knowing the HPV genotype of a patient helps with stratifying risk of individuals for cervical cancer.

Latest in HPV
Hpv Niaid Social
University of Florida researchers develop CRISPR-based assay for HPV detection
May 7, 2024
Body composition in patients treated with Ozempic
Sponsored
Body composition in patients treated with Ozempic
September 20, 2024
Lab Woman Dna Social
Roche receives WHO prequalification for HPV screening tool
June 13, 2023
Hpv Infection Social
Mailed HPV home test kits doubled cervical cancer screening rates in study
May 12, 2023
Related Stories
Hpv Infection Social
HPV
Mailed HPV home test kits doubled cervical cancer screening rates in study
2022 03 01 17 44 8262 Sequencing Virus 400
PCR
New RT-PCR technique augments NGS for variant classification
2020 10 23 23 07 4156 Becton Aacc 2019 400
Infectious
BD sees Q1 revenues up 26% as COVID-19 testing drives sales
Body composition in patients treated with Ozempic
Sponsor Content
Body composition in patients treated with Ozempic
More in HPV
University of Florida researchers develop CRISPR-based assay for HPV detection
By LabPulse.com staff writers
Researchers at the University of Florida have developed a testing method that utilizes CRISPR gene-editing technology to detect HPV in blood or saliva samples that could promote earlier cervical cancer detection.
May 7, 2024
Hpv Niaid Social
HPV point-of-care test in development combines isothermal amplification, lateral flow detection
By LabPulse.com staff writers
A testing platform that combines the two technologies often used separately in diagnostic tests could simplify the equipment and procedures needed for HPV testing.
June 23, 2023
Hpv Infection Social
Roche receives WHO prequalification for HPV screening tool
By LabPulse.com staff writers
Prequalification helps expand access to the screening tool in countries that rely on the WHO's list of prequalified suppliers in making purchasing and implementation decisions.
June 13, 2023
Lab Woman Dna Social
Mailed HPV home test kits doubled cervical cancer screening rates in study
By Elissa Wolfson
Mailing human papillomavirus (HPV) self-collection kits for at-home use improved cervical cancer screening in under-screened, low-income women by nearly two-fold.
May 12, 2023
Hpv Infection Social
Mayo Clinic, Naveris collaborate to evaluate HPV DNA test in clinical trial
By LabPulse.com staff writers
The test is being developed with the aim of aiding treatment selection for patients with HPV-driven head and neck cancer.
April 13, 2023
Head Neck Social
Becton Dickinson HPV assay FDA approved with BD SurePath, Hologic ThinPrep Pap tests
By LabPulse.com staff writers
The BD Onclarity HPV Assay individually tests for an extended set of HPV types, including HPV 31, which poses a higher risk for causing cervical precancer than HPV 18, Becton Dickinson said.
February 21, 2023
Hpv Infection Social
BioReference offering Roche Diagnostics cytology test for women at high risk for HPV
By LabPulse.com staff writers
The test uses dual biomarker technology to simultaneously detect p16 and Ki-67 in women with HPV-positive results.
February 9, 2023
Hpv Infection Social
Virax Biolabs obtains CE Mark, introduces human papillomavirus test kit
By LabPulse.com staff writers
The HPV test kit covers 18 genotypes of the human papillomavirus, including type 53, which is higher risk and becoming increasingly prevalent.
January 4, 2023
Hpv Infection Social
Enzo launches RNA gene expression platform for HPV
By LabPulse.com staff writers
The platform's products combine sequence-specific probes with Enzo's LoopRNA in situ hybridization (ISH) technology, enabling the products to detect target genes in tissue or cell samples while preserving the morphology, Enzo said. This study of single cells within their native tissue environment, called spatial biology, helps scientists characterize and understand disease, Enzo added.
September 25, 2022
2019 05 17 20 09 8391 Hpv 400
TTS, OmniPathology to offer oral HPV testing in L.A.
By LabPulse.com staff writers
A throat swab enables the detection of 14 high-risk strains of HPV by pathologists at OmniPathology's high-complexity, CLIA-certified pathology laboratory in Pasadena, CA.
August 16, 2022
2019 05 17 20 09 8391 Hpv 400
OmniPathology launches lab-developed test for HPV
By LabPulse.com staff writers
The PCR-based test detects 14 high-risk strains of HPV, a virus with potential to progress to cancer. It is performed on a throat swab submitted for testing to OmniPathology's CLIA-certified laboratory in Pasadena, CA, and helps screen for oropharyngeal cancer and early premalignant lesions.
July 11, 2022
2019 05 15 20 52 2340 Lab Pcr Tubes Dna 400
Bio-Techne launches HPV assay in Europe
By LabPulse.com staff writers
RNAscope in situ hybridization (ISH) is a highly sensitive and specific spatial biology technology, Bio-Techne said.
July 5, 2022
2020 07 29 23 56 6775 Hpv Infection 400
Page 1 of 3
Next Page