KLOKKARSTUA, Norway, August 4, 2021 / PRNewswire / – Mel-Mont Medical, a medical device and technology boutique company dedicated to improving women’s health through the use of its patented Mia by XytoTest® self-sampling DNA and mRNA screening kit, maintains clinical validation as equally effective to a sample collected by the doctor.
“Current estimates show that 569,847 women are diagnosed with cervical cancer and 311,365 die from the disease each year. Cervical cancer is the third most common cancer in women worldwide,” according to the Globocan HPV and Cancer Information Center.
The Mia by XytoTest® device is safe to use by women at home or by a doctor in the office without the need for a vaginal speculum. The uniqueness of Mía by XytoTest® enables sexually active women to improve their opportunities for self-care and screening for HPV-related cancers. The patented Mia technology from XytoTest® enables laboratories to detect Hr-HPV-DNA and enables risk stratification through the detection of the biomarker mRNA E6 / E7 from the seven HPV types that have been shown to be the most important for the progression to cervical cancer.
“The idea of self-testing with Mía by XytoTest® arose from the need to raise awareness of self-sufficiency and the need for accessible routine preventive tests in the sexually active female population. Molecular screening increases sensitivity and specificity and increases clinical value in combating high morbidity and mortality diseases that are ironically preventable, such as cervical cancer, “said Mel-Mont Medical CEO, Frank Meléndez.
One recently publication1 A comparison of self-collected cervical samples taken by clinicians for the detection of HPV infections using a 14-type HPV DNA test and a 7-type HPV mRNA E6 / E7 test comes to the conclusion that Mia by XytoTest® corresponds qualitatively to the samples taken by clinicians.
“The claim that self-collected samples that are accessible for HPV mRNA tests are CE-marked according to the IVD directive 98/97 / EG, makes PreTect and its E6 / E7 mRNA technology a pioneer of this promising one Strategy, ”said Bente Marie Falang, Global Director of In Vitro Division at PreTect, AS.
In addition to effective self-sampling, women who test positive for HPV will then work with their doctors to prescribe appropriate treatment recommendations specifically for each woman’s mRNA biomarkers.
Mia by XytoTest® and 7-type mRNA E6 / E7 offer women new and innovative alternatives in the prevention of cervical cancer and are now being used across the board Europe and Mexico. In addition, the device enables women in health-disadvantaged countries or in difficult economic circumstances to access affordable, life-changing technologies.
“Integrative multidisciplinary molecular tests Accurate triage of exfoliated cervical samples improves cervical cancer prevention programs while simplifying health procedures in HPV infected women. Therefore, the concept of a “liquid biopsy” (ie, “molecular” Pap test), which is highly specific for the early detection of cervical precancerous lesions, will be of vital importance in the years to come. “2 stated Ana Gradíssimo, Ph.D. the end Albert Einstein College of medicine, Bronx, NY a recent publication (2).
About Mel-Mont Medical, Inc .:
Mel-Mont Medical, with offices in The United States and Europe, is a boutique medical device and technology company that originally focused on products that use mRNA to screen and diagnose HPV-related cancers through minimally invasive agents.
About PreTect, AS:
PreTect AS, a fully ISO 13485: 2016, CE / IVD certified and FDA registered mRNA production facility based in Klokkarstua, Norway, is a wholly owned subsidiary of Mel-Mont Medical, Inc.
SOURCE Mel-Mont Medical, Inc.