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Shipment box for Mia Sample Self-Collection Device

Mia Sample Self-Collection Device Box

Mia Device for Self or Physician Sample Collection

Mia Collection Device

Improved screening rates & testing accuracy will accelerate HPV cancer eradication

...Bringing the Mía device to Europe... is changing the testing experience completely, expanding HPV screening exponentially in Spain, with many other countries, including the US, soon to follow.”
— Imanol Mangado, Managing Director for Mel-Mont Medical in Europe

MIAMI, FLORIDA, UNITED STATES, May 17, 2024 / -- Mel-Mont Medical, Inc., an innovative leader in precision HPV mRNA extended genotyping and sample collection devices, has announced it has reached a key milestone, providing its CE-marked Mía by Xytotest™ device, which enables sample collection and HPV testing for over 25,000 women in Spain, as well as over 8,000 women in Mexico, and more worldwide.

“Launching products that are fundamentally changing women’s health care for the better into North American markets has been an incredibly rewarding team effort,” says Octavio Gonzalez Peredo, Mel-Mont Medical’s Chief Commercial Officer based in Mexico City, who has led commercialization strategy and efforts most recently in Mexico.

HPV screening is an essential practice and global health concern, since most cervical cancer (the #4 most-common malignancy among women worldwide) is HPV-derived and can be prevented if caught early enough. The World Health Organization (WHO) has rolled out an initiative designed to end HPV-related cancers, supporting education, vaccination, and increased HPV testing. (1)

Frank Melendez and Liliana Montes, co-Founders of Mel-Mont Medical, Inc. developed the Mía collection device several years ago with the intent of addressing the inconvenience, cost, discomfort, and anxiety conventional procedures can cause for patients, thus removing barriers to HPV regular screening and follow up. Mel-Mont’s proprietary device utilizes adhesion material and a simple robust design, which has shown increased sample cell collection over traditional pelvic exam speculum collection. (2) Patient sample collection using the Mía device has also demonstrated equivalent test results compared to physician collection. (3)

Mel-Mont’s HPV Proofer7™ mRNA E6 and E7 Biomarker Test (developed by Norwegian company PreTect, AS, and acquired by Mel-Mont in 2020) utilizes gene expression profiling of 14 biomarkers (E6 and E7 of the highest-risk human papillomavirus [HPV] types 16, 18, 31, 33, 45, 52, 58), via real-time nucleic acid sequence-based amplification (NASBA) to analyze epithelial cells collected from and around a patient’s cervix. Positive or negative status of each separate HPV type is resulted on each clinical report.

Adding the Mía sample collection device as well as the Proofer7 mRNA test to standard DNA screening creates a highly accurate, convenient screening workflow for cervical cancer prevention. Both products, their granted patents, and their registered trademarks are owned by Mel-Mont Medical, Inc., which is actively working to obtain FDA approvals for both products.

“Since bringing the Mía device to Europe, top labs and genecologists are using or distributing the device,” says Imanol Mangado, Managing Director for Mel-Mont Medical in Europe. “This is changing the testing experience completely, and expanding HPV screening exponentially in Spain, with many other countries, including the US, soon to follow.”

The company will accept patient self-collected samples in its Norway, Mexico, and Spain laboratories, as well as physician-collected patient samples worldwide for processing in its clinical laboratories in the above locations as well as in Atlanta, Georgia, USA. HPV DNA primary screening as well as Proofer 7 mRNA reflex testing is performed in each lab. Email for testing information about the HPV Proofer 7 mRNA LDT or the Mía sample collection device.

About Mel-Mont Medical, Inc.
Mel-Mont Medical, Inc. is an innovative leader in precision HPV mRNA extended genotyping and sample collection devices that address global health concerns. The company designs, develops, and markets state-of-the-art technologies and medical services that preserve life through the prevention, early diagnosis, and informed management of virus-related pathologies. Since 2020, Mel-Mont Medical has been facilitating HPV testing for women in Europe and North America, where it operates multiple high-complexity laboratories. The company is continually growing and expanding to meet worldwide demand.
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

email us here
Frank Melendez
Mel-Mont Medical Inc.

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