IMPACT trial data shows clear benefit in using Roche’s CINtec PLUS Cytology test for women who are at higher risk of developing cervical cancer

  • Every year, over 604,000 women worldwide are diagnosed with cervical cancer and approximately 342,000 die from this preventable disease, caused by Infection with high-risk human papillomavirus (HPV).
  • As recently published in the International Journal of Cancer, the IMPACT (IMproving Primary screening And Colposcopy Triage) trial demonstrated that Roche’s CINtec PLUS Cytology, when used as a triage test for high-risk HPV, showed a significantly higher sensitivity in detecting cervical pre-cancers in HPV-positive women compared to Pap cytology.
  • It is the first FDA-approved dual-stain biomarker technology available for clinicians to guide decision-making based on individual patient risk, with the goal of helping to eliminate cervical cancer.

Roche moment blazoned that results from the IMPACT ( Perfecting Primary webbing And Colposcopy Triage) trial demonstrate clear case benefit in using Roche’s CINtec PLUS Cytology binary- stain biomarker technology as a triage test for women who test positive for high- threat mortal papillomavirus (HPV). The data from the trial, established from a study cohort of further than women aged 25-65 times, was published lately in the International Journal of Cancer.1

In the IMPACT trial, women who were positive for high- threat HPV entered a follow-up triage test to help determine if their cervical cells were transubstantiating to cervicalpre-cancer. The biomarker- grounded CINtec PLUS Cytology test showed a significantly advanced perceptivity in detecting cervicalpre-cancers, compared to Pap cytology. The Roche test aids clinicians in further confidently determining which women are at increased threat for high- grade cervicalpre-cancer and bear immediate farther individual procedures, and which women may need reprise testing or routine webbing.1
Over women are diagnosed with cervical cancer worldwide each time and roughly bones from the complaint.2 Patient infection with high- threat HPV is the top cause of cervical cancer, intertwined in further than 99 percent of cases worldwide.3 Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, webbing and treatment.

“ As we approach the one- time anniversary of the World Health Organization’s global strategy to accelerate the elimination of cervical cancer, Roche is committed to investing in and leading sweats similar as the IMPACT trial to bring forth clinically validated results for women,” said Thomas Schinecker, CEO Roche Diagnostics. “ The elimination of cervical cancer is within reach, and all countries must act now so that women, no matter where in the world they live, no longer die from this preventable complaint. Our investment in HPV primary webbing and coming- generation biomarker technology gives clinicians indeed more important tools in the fight against cervical cancer.”
“These rearmost results from the IMPACT trial confirm data from former studies that show incorporating the CINtec PLUS Cytology test in cervical cancer webbing programs can give real benefits to both clinicians and their cases,”saysDr. Thomas Wright, Professor Emeritus in Pathology and Cell Biology at Columbia University Medical Center, New York.”As a triage test for HPV-positive cervical cancer webbing results, the CINtec PLUS Cytology test can be veritably useful to separate women who’ll profit utmost from immediate referral to colposcopy from those women who can be followed up with lower invasive styles.”

About Cervical Cancer and the IMproving Primary webbing And Colposcopy Triage ( IMPACT) Trial
Cervical cancer is nearly 100 percent preventable with proper HPV vaccination, webbing and treatment. Further than new cases of cervical cancer are diagnosed each time worldwide. In 2020, cervical cancer was responsible for7.7 percent of all womanish cancer deaths
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About CINtec PLUS Cytology
The CINtec PLUS Cytology test detects the contemporaneous presence within a single cell of the two biomarkers– p16 and Ki-67. This abnormality is associated with HPV infections that are transubstantiating and can, if left undressed, progress topre-cancer or cancer. A positive result of these two biomarkers in a single cell signals that a woman is more significantly at threat for complaint. The capability of CINtec PLUS Cytology to distinguish those women who are at a advanced threat for cervical complaint, in confluence with the clinician’s assessment of patient webbing history and other threat factors, provides labs, croakers and women with the information demanded to guide patient operation. Women with negative binary- stain results are at significantly lower threat for cervical complaint and their bodies can be given further time to clear the HPV infection on their own. This could reduce the number and frequence of follow-up visits, saving some cases worry and time.
The CINtec PLUS Cytology test, which runs on the BenchMark ULTRA IHC/ ISH system, is performed using the same sample that’s used for HPV or liquid- grounded Pap cytology tests. This eliminates the need for fresh or repeat sample collection or time spent staying to find out if an infection is clearing.

CINtec PLUS Cytology, now available encyclopedically, was FDA approved in March 2020.
About Roche
Roche is a global colonist in medicinals and diagnostics concentrated on advancing wisdom to ameliorate people’s lives. The combined strengths of medicinals and diagnostics, as well as growing capabilities in the area of data- driven medical perceptivity help Roche deliver truly personalised healthcare. Roche is working with mates across the healthcare sector to give the stylish care for each person.
Roche is the world’s largest biotech company, with truly discerned drugs in oncology, immunology, contagious conditions, ophthalmology and conditions of the central nervous system. Roche is also the world leader in in vitro diagnostics and towel- grounded cancer diagnostics, and a frontrunner in diabetes operation. In recent times, Roche has invested in genomic profiling and real- world data hookups and has come an assiduity- leading mate for medical perceptivity.

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