Mel-Mont Medical announces the validation of its patented self-sampling technology, Mía by XytoTest®, for molecular screening using HPV-DNA and 7-Type mRNA E6/E7.
KLOKKARSTUA, Norway, Aug. 4, 2021 /PRNewswire/ -- Mel-Mont Medical, a boutique medical device and technology company dedicated to improving women's health through the use of its DNA and mRNA patented self-sampling screening kit, Mia by XytoTest®, receives clinical validation as being equally effective to clinician-collected sampling.
"Because Prevention is Possible"
KLOKKARSTUA, Norway, Aug. 4, 2021 /PRNewswire/ -- Mel-Mont Medical, a boutique medical device and technology company dedicated to improving women's health through the use of its DNA and mRNA patented self-sampling screening kit, Mia by XytoTest®, receives clinical validation as being equally effective to clinician-collected sampling.
"Current estimates indicate that every year 569,847 women are diagnosed with cervical cancer, and 311,365 die from the disease. Cervical cancer ranks as the third most frequent cancer among women in the world," according to Globocan information center on HPV and cancer.
The Mia by XytoTest® device can be safely used by women at home, or in-office by a clinician, without the need for a vaginal speculum. The uniqueness of Mía by XytoTest® empowers sexually active women to further their self-care opportunities and pre-screen for HPV-caused cancers. The patented technology that is Mia by XytoTest® enables laboratories to detect Hr-HPV DNA and allows for risk stratification by detecting biomarkers mRNA E6/E7 from the seven HPV-types proven to be the most crucial for progression to cervical cancer.
"The idea of self-collection using Mía by XytoTest® arose from the need to raise awareness of self-care and the need for accessible, routine preventative testing among the sexually active female population. Molecular screening increases sensitivity and specificity, adding clinical value to fight diseases with high morbidity and mortality rates that are ironically preventable, such as cervical cancer," said Mel-Mont Medical's CEO, Frank Meléndez.
A recent publication1 comparing self-collected to clinician-collected cervical samples to detect HPV infections by a 14-type HPV DNA test and a 7-type HPV mRNA E6/E7 test concludes that Mia by XytoTest® equals clinician-collected samples in quality.
"Claiming self-collected specimens accessible for HPV mRNA testing was CE marked to the IVD directive 98/97/EC cleared, making PreTect and its E6/E7 mRNA technology a pioneer for this promising strategy," said Bente Marie Falang, Global Director of In-vitro Division at PreTect, AS.
In addition to providing effective self-sampling options, women who test positive for HPV are, along with their physicians, then prescribed appropriate treatment recommendations specific to each woman's mRNA biomarkers.
Mia by XytoTest® and 7-type mRNA E6/E7 afford women new and innovative alternatives in cervical cancer prevention and are now being used across Europe and Mexico. Further, the device permits women in healthcare-deprived countries or with economically-distressed circumstances to access affordable, live-changing technology.
"Integrative multi-disciplinary molecular tests accurately triaging exfoliated cervical specimens will improve cervical cancer prevention programs while simplifying healthcare procedures in HPV-infected women. Hence, the concept of a "liquid biopsy" (i.e., "molecular" Pap test) highly specific for early identification of cervical precancerous lesions is of critical importance in the years to come,"2 indicated Ana Gradíssimo, Ph.D. from Albert Einstein College of Medicine, Bronx, NY a recent publication (2).
About Mel-Mont Medical, Inc.:
Mel-Mont Medical, having offices in the United States and Europe, is a boutique medical device and technology company initially focused on products that use mRNA to screen and diagnose, through minimally-invasive means, HPV-caused cancers.
About PreTect, AS:
PreTect AS, a fully ISO 13485:2016, CE/IVD certified, and FDA registered mRNA manufacturing facility based in Klokkarstua, Norway, is a wholly-owned subsidiary of Mel-Mont Medical, Inc.
1 https://rdcu.be/clGVo
2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5904788/
For more information:
Bente Marie Falang
Ustadhagan 8 /N-3490
Klokkarstua, Norway
Phone: +47.32.79.88.00
Email: [email protected]
Web: www.mel-montmedical.com
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