- According to the U.S. Centers for Disease Control (CDC), most
sexually active adults will experience HPV infections; new test
detects those HPV genotypes that could lead to cancer
- Abbott's new HPV test uses molecular technology to provide
genotype determination on the 14 high-risk, cancer-causing types of
HPV
- The test is one of the fewi HPV tests approved
for use as a primary screen for cervical cancer as recommended by
professional guidelines
ABBOTT
PARK, Ill., Nov. 2, 2023
/PRNewswire/ -- Abbott (NYSE: ABT) has received U.S. Food and Drug
Administration (FDA) approval for its molecular human
papillomavirus or HPV screening solution, adding a powerful cancer
screening tool for detecting high-risk HPV infections to the
Alinity m family of diagnostic assays.
According to the U.S. Centers for Disease Control (CDC), HPV
infection is extremely common – most sexually active adults will
experience an HPV infection at some point in their lives. There are
many different strains of HPV, each with a unique genetic signature
or genotype. Specific genotypes of HPV can cause cancer, including
cervical cancer in women. Historically, Pap tests were used to
screen for cervical cancer, but today professional
guidelinesii recommend testing for HPV infections,
called primary screening, over Pap testing as the best way to
screen for cervical cancer. However, some commonly used HPV tests
are not approved for primary screening and only deliver limited
information regarding which of the many different genotypes of HPV
are present.
The Alinity m high risk (HR) HPV assay is approved as a test for
HPV detection and for use in routine cervical cancer screening as
per professional medical guidelines. The assay is also approved for
use in combination with a Pap test, for patients and physicians who
prefer to use both tests, called co-testing. Importantly, the
Alinity m HR HPV assay delivers information on five risk groups
covering the 14 different potentially cancer-causing genotypes of
the virus, helping physicians identify not just if a patient has an
HPV infection but whether that infection is caused by one (or more)
of the types that may cause cancer.
"Professional guidelines are clear in their recommendation to
shift away from Pap tests in favor of clinically validated, primary
HPV testing as the best way to detect risk of cervical precancer
and cancer," said Mark H. Stoler,
M.D., professor (emeritus) of pathology and clinical gynecology at
the University of Virginia. "As more
women are vaccinated against the highest risk strains of the virus,
it continues to be important to screen women for other HPV strains
that have the potential to cause cancer. Extended genotyping
enables us to improve risk assessment and tailor follow up for
patients so we can minimize unnecessary treatment while still
guarding against cancer development."
"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," said Keith Cienkus, vice
president of Abbott's molecular business. "The Alinity m HR HPV
assay was carefully designed to support patient care and streamline
HPV testing."
The Abbott Alinity m HR HPV assay will be available for use on
Abbott's Alinity m laboratory instrument, Abbott's most
advanced molecular PCR platform which provides fast results in high
volumes. Assays available for use on the Alinity m system in the
U.S. include: SARS-CoV-2 (Emergency Use Authorization), Resp-4-Plex
(Emergency Use Authorization), HCV (Hepatitis C), HBV (Hepatitis
B), HIV-1 (Human Immunodeficiency Virus type 1), STI (CT/NG/TV/MG),
CMV (Cytomegalovirus) and EBV (Epstein–Barr virus).
About Alinity:
Abbott's Alinity family of harmonized solutions is unprecedented in
the diagnostics industry, working together to address the
challenges of using multiple diagnostic platforms and simplifying
diagnostic testing. Alinity systems are designed to be efficient –
with the goal of running more tests in less space, generating test
results faster, and minimizing human errors – while continuing to
provide quality results. The availability of the Alinity systems
and tests varies by geography. More information is available
at alinity.com.
About Abbott:
Abbott is a global healthcare leader
that helps people live more fully at all stages of life. Our
portfolio of life-changing technologies spans the spectrum of
healthcare, with leading businesses and products in diagnostics,
medical devices, nutritionals and branded generic medicines. Our
115,000 colleagues serve people in more than 160 countries.
Connect with us at www.abbott.com, on LinkedIn
at www.linkedin.com/company/abbott-/, on Facebook
at www.facebook.com/Abbott and on Twitter
@AbbottNews.
i U.S. Food and Drug Administration. See
www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm
ii The American College of Obstetricians and Gynecologists
(ACOG), the Society of Gynecologic Oncology (SGO) and the American
Society for Colposcopy and Cervical Pathology (ASCCP) all endorse
the U.S. Preventative Services Task Force (USPSTF) cervical cancer
screening recommendations. See ACOG Updated Cervical Cancer
Screening Guidelines reaffirmed April
2023.
https://www.acog.org/clinical/clinical-guidance/practice-advisory/articles/2021/04/updated-cervical-cancer-screening-guidelines
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SOURCE Abbott