Instead of a traditional speculum-involved pelvic exam to screen for cervical cancer, the US Food and Drug Administration has given the go-ahead for patients to have the option to collect their own vaginal samples for screening in a health care setting, such as at their doctor’s office, an urgent care or even a mobile clinic.
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the FDA approval of its human papillomavirus (HPV) self-collection solution, one of the first available in the United States. Screening for HPV can help identify women who are at risk of developing cervical cancer so that the disease can be found and treated early before cervical cancer has a chance to develop.
Roche announced on Tuesday that its Cobas HPV test has received approval from the US Food and Drug Administration for use on the Cobas 5800 instrument.
Abbott announced on Thursday that its molecular test for human papillomavirus has received regulatory approval from the US Food and Drug Administration.
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Researchers have determined that a liquid biopsy human papillomavirus DNA test may serve as a useful tool for the diagnosis and surveillance of HPV-associated oropharyngeal squamous cell carcinoma (OPSCC).
Rice University bioengineers said this week that they have demonstrated a low-cost, point-of-care DNA test for HPV infections that could make cervical cancer screening more accessible in low- and middle-income countries where the disease kills more than 300,000 women each year.
Roche announced that the cobas® HPV test for use on the cobas® 6800/8800 Systems has been awarded World Health Organization (WHO) prequalification. WHO prequalification expands the availability of this critical HPV screening tool in countries that rely on the global organisation’s list in making purchasing and implementation decisions.
Becton, Dickinson and Company (BD) and CerTest Biotec have announced that their molecular assay for detecting the Mpox virus has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
The US Food and Drug Administration this week granted Emergency Use Authorization for OnsiteGene's Hi-Sense COVID-19 Molecular Testing Kit 1.0.
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