USA — Abbott has received the stamp of approval from the US Food and Drug Administration (FDA) for a groundbreaking human papillomavirus (HPV) screening solution that seamlessly integrates with its Alinity m laboratory instrument.
The newly sanctioned test, named the Alinity m high-risk (HR) HPV assay, aligns perfectly with professional medical guidelines for routine cervical cancer screening.
By harnessing the power of molecular technology, this test offers vital insights into five distinct risk groups, encompassing 14 different HPV genotypes known for their potential to trigger cancer.
The Alinity m HR HPV assay equips healthcare providers with a robust tool for identifying high-risk HPV infections in line with the Alinity m family of diagnostic assays, as highlighted by the US medical device company.
Abbott’s Vice President of Molecular Business, Keith Cienkus, emphasized the significance of HPV testing, particularly in the context of infectious diseases: “HPV testing is a powerful tool for detecting HPV infections that can lead to certain cancers, including cervical cancer, and illustrates the power of molecular diagnostics in infectious disease.”
Cervical cancer, often associated with HPV infections, is a major concern for women’s health. The Alinity m HR HPV assay is carefully designed to enhance patient care and streamline HPV testing, providing a much-needed solution in the fight against this form of cancer.
Statistics from the US Centers for Disease Control (CDC) underscore the prevalence of HPV infections, particularly among sexually active adults, who are at risk of experiencing an HPV infection at some point in their lives.
HPV comprises various strains, each characterized by a unique genetic signature or genotype. Specific HPV genotypes have the potential to cause cancer, with cervical cancer being a prominent example.
Traditionally, Pap tests were the go-to method for cervical cancer screening. However, professional guidelines now advocate for primary screening focused on detecting HPV infections, making it the preferred approach over Pap testing.
Despite the shift in recommendations, some widely used HPV tests are not officially endorsed for primary screening because they offer limited information about different HPV genotypes.
Abbott’s Alinity m HR HPV assay not only secures approval for co-testing in combination with a Pap test but also stands alone as a potent tool for primary screening.
This flexibility caters to the preferences of both patients and physicians, offering a comprehensive solution for HPV detection.
Abbott emphasizes that the HPV assay, tailored for use with its laboratory instrument Alinity m, leverages an advanced molecular PCR platform.
This sophisticated technology ensures rapid results in high volumes, contributing to the efficiency of healthcare procedures.
Beyond HPV testing, the versatile Alinity m system extends its capabilities to address a range of critical health concerns, encompassing testing for SARS-CoV-2, Resp-4-Plex, HCV, HBV, HIV-1, STI, CMV, and EBV.
This comprehensive functionality positions it as a valuable asset for the healthcare industry, providing diverse diagnostic solutions to address various infectious diseases.
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