gMendel ® announces the achievement of the Proof of Concept (POC) for itssecond product: gMendel ® Test-BCT (Basic Carrier Test).

August 24, 2023, Copenhagen – gMendel® announced today an important milestone in its development journey – the achievement of the Proof of Concept (POC) for Basic Carrier Test (BCT). BCT, as recommended by the American College Obstetricians Gynecologists (ACOG) and the American College of Medical Genetics (ACMG), identifies adult carriers of all ethnicities of the genetic disorders Spinal Muscular Atrophy (SMA), Cystic Fibrosis (CF) and Fragile X.

Zoran Velkoski, CTO said, ”after having certified our first product gMendel®Test-SCAN in 2022, we are now making tangible progress towards the certification of our second product. The next steps for IVDR product development process include: a) PLC (Product Lifecycle); b) SDLC (Software Development Lifecycle) and c) CE Marking. We expect our second product gMendel®Test-BCT, to reach high analytical performance scores, similar to what we achieved with our first product.”

Dr. Gjorgji Madjarov, CAIO said: “We are pleased to extend our AI end-to-end solution Phivea® to the detection & medical interpretation of SMA and CF. Phivea® can be applied directly on the stream of base-called DNA reads generated by any NGS devise. It exceeds the limits of the real-time monitoring and analysis per DNA sample, which can significantly reduce the overall cost.”

Based on any third-party sequencing technology, the novel gMendel®Test enables real-time analysis of hundreds of molecular barcodes simultaneously in less than 24 hours. gMendel® technology is simple, practical & cost effective, and has greater detection capabilities than the available technologies, with an ability to be extended, scaled & applied for the detection of multiple genetic disorders & beyond.

Dr. Chris Kyriakidis, CEO said: “This groundbreaking work opens an opportunity to substitute current diagnostic tools with more accurate, faster and cost-effective technology, and thereby contribute to improvement of life for people with genetic disorders and beyond by improving the current practices in healthcare.

In 2022, gMendel®Test-SCAN obtained CE mark under EU IVDD, becoming the world’s first IVD certified test for human genetic disorders utilizing Oxford Nanopore.

gMendel®Test-BCT is expected to be offered as an in vitro diagnostic device (IVD) in 2024. Three other products are well on their way of development. Our ultimate goal is to leverage multi-omics, clinical data, and AI for diagnosis and prediction of any disease.

We would like to thank the Innovation Fund Denmark for co-funding this project through the grant: 2055-00069B

About gMendel®

gMendel® is a MedTech company with a sea-change technology for diagnosis of genetic disorders & beyond. gMendel® applies rigorous science and conducts tireless research to develop medical technology solutions that will help patients live longer and better. The gMendel® technology is an AI cloud-based end-to-end solution for the detection & medical interpretation of genetic disorders & beyond. Our technology is simple, practical & cost effective, and has greater detection capabilities than the available technologies, with an ability to be extended, scaled & applied for the detection of multiple genetic disorders & beyond. gMendel®’s products and services accelerate the diagnosis journey and advance inclusion, diversity and equity in care and treatment. Our ultimate goal is to leverage multi-omics, clinical data, and AI for diagnosis and prediction of any disease.