Research & Development
HPV: Page 2
Seegene develops '3 Ct' assay for HPV infection
The Allplex HPV HR assay detects 14 high-risk HPV types that cause cervical cancer. The assay provides the individual Ct value of each cancer type, allowing quantitative analysis to determine the infection level. The test is expected to be launched in the first half of 2022.
April 26, 2022
Enzo's HPV test approved by New York health department
Ampiprobe is the company's PCR-based test which can detect 14 high-risk HPV variants. The company said this approval positions it to pursue U.S. and international regulatory approvals.
April 18, 2022
FDA approves BD genotyping capabilities for HPV assay
The supplement expands the genotype reporting for BD's Onclarity HPV assay beyond HPV genotypes 16, 18, and 45 to include types 31, 51, 52, 33/58, 35/39/68, and 56/59/66. The assay will become the only FDA-approved assay to individually identify and report these genotype results, according to the company.
March 8, 2022
Blood test predicts recurrence of HPV-driven oropharyngeal cancer
The multi-institutional study, presented by Dr. Glenn Hanna from the Dana-Farber Cancer Institute, indicated that the biomarker test may detect recurrent disease earlier than imaging or
February 24, 2022
Hologic adds SARS-CoV-2 test to global testing project
Hologic launched GAI at the 2018 International AIDS Conference as an initiative to offer an all-inclusive pricing structure with no upfront cost or capital expenditure. In addition to the SARS-CoV-2 assay, the company offers other tests in the initiative, including tests for HIV-1, hepatitis B and C, and HPV.
January 4, 2022
BD launches new BD Cor molecular diagnostics system
The BD Cor system uses robotics and sample management software algorithms. It is modular, scalable, and designed to address multiple needs within clinical labs for expanding molecular testing and increasing testing volumes.
August 24, 2021
Mel-Mont validates self-sampling kit
Norwegian researchers tested the kit's performance in a group of 500 women at detecting rates of genital HPV infection compared to clinician-collected samples. The study found "fair agreement" of HPV positivity rates between the two methods, according to the authors. The study was published in BMC Infectious Diseases.
August 4, 2021
Sysmex Inostics touts liquid biopsy findings at ASCO
The featured data will show how the company's SafeSEQ cfHPV-DNA Test (HPV-SEQ) detects cell-free HPV DNA, enabling monitoring for patients with HPV and oropharyngeal squamous cell carcinoma (OPSCC), a type of head and neck cancer.
June 3, 2021
BD seeks FDA OK to use more samples with HPV test
The company submitted a premarket approval supplement to the agency because it would expand the sample claims that can be used with the HPV assay. Currently, the assay is approved for use with BD's SurePath vial for the detection of HPV.
September 22, 2020
ACS cervical cancer guidelines disappoint some testing firms
The current standard of care is to use the Pap test for women ages 21 to 29 and a combination of both the Pap test and HPV test (cotesting) for women between the ages of 30 and 65. The ACS guidelines, which were published July 30, would shift to HPV testing only, and Hologic claims this would erode access to preventative healthcare and could sow confusion among women and their healthcare providers.
July 30, 2020
National cervical cancer screening guidelines shift to primary HPV testing
The ACS published a 2020 update to guidelines for cervical cancer screening for individuals at average risk in its publication CA: A Cancer Journal for Clinicians online July 30. Guidelines were last updated in 2012.
July 30, 2020
BD's expanded genotype HPV test gets FDA nod
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.
July 22, 2020
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