Roche announces FDA approval of one of the first HPV self-collection solutions in the U.S., expanding access and screening options to help eliminate cervical cancer
May 15 2024 - 12:00AM
UK Regulatory
Roche announces FDA approval of one of the first HPV
self-collection solutions in the U.S., expanding access and
screening options to help eliminate cervical cancer
- More than half of all U.S.
cervical cancer patients are
underscreened1, which
makes reducing barriers to sample collection and increasing access
to screenings crucial to ultimately helping eliminate this deadly
disease.
- Each year in the U.S., more
than 13,000 patients are diagnosed with cervical cancer and
approximately 4,000 die from this preventable disease, caused by
HPV infection.1
- Roche’s human
papillomavirus (HPV) self-collection solution will improve access
to testing by providing women the option to privately collect their
own sample.
Basel, 15 May 2024 - 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.
HPV self-collection offers an accessible screening option. In a
healthcare setting, an individual collects their own vaginal
sample, which is sent to a laboratory for analysis with Roche’s
cobas® molecular instrument. Those who receive a positive HPV
result would then continue their care with a healthcare
provider.
“With vaccinations, innovative diagnostic tools and screening
programs, achieving the WHO’s goal of eliminating cervical cancer
by 2030 is within reach,” said Matt Sause, CEO of Roche
Diagnostics. “Our HPV self-collection solution helps support this
goal by reducing barriers and providing access to HPV screening by
allowing people to privately collect their own sample for HPV
testing.”
More than half the patients diagnosed with cervical cancer in
the U.S. have never been screened or have only been screened
infrequently, and they do not participate in routine
screening.1 Many factors can contribute to individuals
not participating in cervical cancer screening programs, such as
access to healthcare, social and economic barriers, history of
traumatic experience, cultural concerns and embarrassment. Roche’s
self-collection solution can help reduce these barriers by offering
an alternative to clinician collection procedures, while also
providing accurate and reliable results enabling clinicians to make
patient care decisions.
Roche has collaborated with the National Cancer Institute (NCI),
which is part of the National Institutes of Health (NIH), on the
Cervical Cancer “Last Mile” Initiative. This public-private
partnership has, in part, facilitated the regulatory pathway
towards the approval.
About the Roche Cervical Cancer Portfolio
HPV is the known cause of more than 95% of all cervical
cancers.2 Roche’s cervical cancer portfolio includes the
cobas HPV Test, used for primary screening and co-testing. While
the Pap smear can potentially detect abnormalities in the cervix,
the cobas HPV test detects 14 types of high-risk HPV genotypes that
put patients at higher risk of cervical cancer. It includes results
for HPV 16, HPV 18 and 12 other high-risk pooled
genotypes.3
The HPV self-collection solution is approved for use with
Roche's cobas HPV test. The cobas HPV test runs on the cobas 4800
and the fully automated cobas 5800/6800/8800 Systems, which offers
the fastest time to results, providing up to 96 results in about
three hours, and 384 results for the cobas 6800 System and 1,056
results for the cobas 8800 System in an eight hour shift. The
portfolio also includes CINtec PLUS Cytology, the only
FDA-approved dual-stain product and CINtec® Histology, the only
FDA-cleared p16 biomarker technology that can help pathologists
confirm the presence of pre-cancerous cervical lesions.
The IMPACT trial design, used to validate the clinical benefits
of the Roche cervical cancer portfolio, had representation from
diverse patient segments, including 21 percent Black, 24 percent
Hispanic-Latino and 0.3 percent American Indian or Alaskan Native
participants.4 This diversity was critical to accurately
assess the performance of dual stain in patient populations with
higher incident rates of HPV. Learn more now:
http://diagnostics.roche.com
About Roche
Founded in 1896 in Basel, Switzerland, as one of the first
industrial manufacturers of branded medicines, Roche has grown into
the world’s largest biotechnology company and the global leader in
in-vitro diagnostics. The company pursues scientific excellence to
discover and develop medicines and diagnostics for improving and
saving the lives of people around the world. We are a pioneer in
personalised healthcare and want to further transform how
healthcare is delivered to have an even greater impact. To provide
the best care for each person we partner with many stakeholders and
combine our strengths in Diagnostics and Pharma with data insights
from the clinical practice.
In recognising our endeavour to pursue a long-term perspective
in all we do, Roche has been named one of the most sustainable
companies in the pharmaceuticals industry by the Dow Jones
Sustainability Indices for the fifteenth consecutive year. This
distinction also reflects our efforts to improve access to
healthcare together with local partners in every country we
work.
Genentech, in the United States, is a wholly owned member of the
Roche Group. Roche is the majority shareholder in Chugai
Pharmaceutical, Japan.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected
by law.
References
[1]
https://deainfo.nci.nih.gov/advisory/joint/1219/Sahasrabuddhe.pdf
[2] WHO cervical cancer fact sheet
[3] cobas® HPV test [package insert]. Branchburg, NJ: Roche
Molecular Systems, Inc.; 2020.
[4] Safaeian M, Wright TC Jr, Stoler MH, Ranger-Moore J, Rehm S,
Aslam S, Fang Q, Volkir P, Ridder R. The IMproving Primary
Screening And Colposcopy Triage trial: human papillomavirus,
cervical cytology, and histopathologic results from the baseline
and 1-year follow-up phase. Am J Obstet Gynecol. 2021
Sep;225(3):278.e1-278.e16. doi: 10.1016/j.ajog.2021.03.047. Epub
2021 Apr 20. PMID: 33852886
Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com
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