PROOFER 7 EXTENDED GENOTYPING IMPROVES HPV SCREENING ACCURACY

Novel mRNA Platform Key Step to Eradicating Cervical Cancer

MIAMI, FLORIDA, USA, June 20, 2024 /EINPresswire.com/ — Mel-Mont Medical, Inc., an innovative leader in precision HPV mRNA extended genotyping and sample collection devices, continues to demonstrate impressive performance of the HPV Proofer 7 mRNA E6 and E7 Biomarker Test in clinical settings.

Introducing the Proofer 7 test as a triage to existing HPV screening has achieved these clinical utility outcomes:
• Increased specificity over 30% compared to primary screening alone, more than doubling the accuracy of DNA-positive test results.
• Prioritized 35% of screened patients requiring follow-up procedures or treatment
• Identified 65% of hr-HPV DNA-positive patients who could have averted invasive colposcopies/biopsies as an immediate next step
• Improving efficient stratification of the highest risk cervical lesions (CIN3+)

Routine HPV DNA screening tests reliably detect the presence of human papillomavirus (HPV) in cervical samples. Although most HPV infections are temporary and cleared by the immune system, some infections persist, increasing the risk of cervical cancer. HPV DNA tests are unable to distinguish between temporary and persistent infections, but mRNA testing improves risk assessment among HPV DNA-positive women by focusing on the overexpression of biomarkers E6 and E7, which indicates active viral replication and cellular changes associated with a more significant risk of developing cervical cancer.

The Proofer 7 HPV mRNA E6 and E7 Biomarker Test utilizes gene expression profiling for the qualitative detection and typing of E6 and E7 oncogene mRNA from HPV types 16, 18, 31, 33, 45, 52, and 58 via real-time Nucleic Acid Sequence-Based Amplification (NASBA). Epithelial cells collected from and around a patient’s cervix are analyzed to determine a positive or negative status of each separate HPV type. This test is available as a CLIA Laboratory-Developed Test (LDT) and CE-Marked Test service from Mel-Mont clinical laboratories in Klokkarstua, Norway; Palma de Mallorca, Spain; and Atlanta, Georgia, USA.

Frank Melendez, Co-Founder and CEO of Mel-Mont Medical describes the development and launch of the HPV Proofer 7 mRNA test into the European and Americas markets as “an incredible team effort over the past several years. “We are now seeing these efforts benefit physicians, health systems, and most importantly, patients – Nothing is more exciting than this!”
Email info@mel-montmedical.com for more testing information or to order the HPV Proofer 7 mRNA test.

Sources: Flores, et al. IPVC Presentation 2023; Sørbye, et al. J. of Mol. Path. 2023

About Mel-Mont Medical, Inc.
Mel-Mont Medical, Inc. has emerged as an innovative leader in precision HPV mRNA extended genotyping and sample collection devices, addressing global health concerns. The company designs, develops, and markets state-of-the-art technologies and medical services aimed at preserving life through the prevention, early diagnosis, and informed management of virus-related pathologies. Operating multiple high-complexity laboratories in Europe and North America, Mel-Mont Medical is dedicated to expanding its reach and capabilities to meet the growing worldwide demand for HPV testing.
Media Inquiries: Email to: info@mel-montmedical.com

Mel-Mont Medical Inc.’s wholly owned subsidiaries:
• PreTect, AS: an ISO 13485:2016 manufacturing facility in Klokkarstua, Norway
• MC2 Molecular Biology, SL: a clinical testing facility in Palma de Mallorca, Spain
• MHS Farma 72, SL: a licensed EU logistics center in Palma de Mallorca, Spain
• Global 7 Diagnostics Labs, LLC: a CAP (#8168228)/CLIA (#11D2130154) clinical testing lab in Atlanta, GA

Mel-Mont Medical Inc.
email us here
Frank Melendez