Cintec plus cytology fda approval

What is the FDA approved HPV testing platform?
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..
Which clinical trials assessed the CINtec plus cytology test?
The FDA approved the HPV test to be used for women over 30 years old.
It may find HPV even before there are changes to the cervix.
Women who have the HPV test still need to get the Pap test..
Which clinical trials assessed the CINtec plus cytology test?
The regulatory decision was based on findings from the registrational IMPACT trial, for which publication of the full data is pending, according to Roche.
In the trial, investigators examined the CINtec PLUS Cytology test as a triage tool in several screening scenarios among a population of over 35,000 women._{Sep 16, 2020}.
Which HPV tests are FDA approved?
The regulatory decision was based on findings from the registrational IMPACT trial, for which publication of the full data is pending, according to Roche.
In the trial, investigators examined the CINtec PLUS Cytology test as a triage tool in several screening scenarios among a population of over 35,000 women._{Sep 16, 2020}.
The CINtec^\xae Histology test is an immunohistochemistry p16 biomarker test that is run on the BenchMark ULTRA IHC/ISH system, as well as BenchMark GX and the legacy Benchmark XT system.
CINtec ^\xae Histology provides objectivity to diagnostic interpretation that helps all pathologists identify more cervical disease.

Sep 16, 2020The CINtec PLUS Cytology test detects the simultaneous presence within a single cell of the two biomarkers -- p16 and Ki-67. This abnormality is

Basel, 16 September 2020 — Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval for the expanded use of CINtec^® PLUS Cytology, the first triage test based on biomarker technology for women whose cervical cancer screening results are positive for high-risk types of human

The FDA approval was supported by data from the registrational IMPACT (Improving Primary screening And Colposcopy Triage) trial. Overall, approximately 35,000 women in the US were enrolled to clinically validate CINtec PLUS Cytology as a triage test in various screening scenarios.

Can a Cintec® test be used as a Pap smear test?

Previously, the manufacturer of the kit recommended the CINtec® test as an adjunct to routine Pap smear test, essentially for the triage of women with ASC-US or LSIL cytology as well as women with NILM cytology and positive HPV test. [ 12] .

Can the Cintec plus cytology CE-IVD test be used for HPV testing?

Prior to FDA approvals for its use for the triage of women who are HPV positive using the cobas HPV Test on the cobas® 4800 or cobas 6800/8800 Systems, the CINtec PLUS Cytology CE-IVD test had been used as a triage test for HPV-positive results and mildly abnormal Pap cytology results in Europe, Asia, South America, Canada and Australia.

When will Cintec plus cytology be available in the US?

CINtec PLUS Cytology is expected to be widely commercially available in the US later in 2020.
The Roche cobas 4800 HPV Test, used in combination with CINtec PLUS Cytology and CINtec® Histology, offers clinicians and labs in the US powerful support they have not had before.

Cintec plus cytology fda approval

What is the FDA approved HPV testing platform?

Which clinical trials assessed the CINtec plus cytology test?

Which clinical trials assessed the CINtec plus cytology test?

Which HPV tests are FDA approved?

Can a Cintec® test be used as a Pap smear test?

Can the Cintec plus cytology CE-IVD test be used for HPV testing?

When will Cintec plus cytology be available in the US?