Multiplicom offers clinical labs early acces to its innovative non-invasive prenatal test

10-02-2015 12:05

Niel - Belgium, February 10th, 2015 – Multiplicom N.V. today announces that it is enrolling molecular diagnostic laboratories in an Early Access Program (EAP) to complete the development of its innovative non-invasive prenatal test (NIPT) branded “Clarigo”. Clarigo identifies fetal aneuploidy – abnormalities of the chromosome number - through the analysis of free circulating DNA isolated from the mother’s blood.

Clarigo is an easy to perform and affordable test, generating highly reliable clinical data, reporting on the fetal ploidy-status of chromosomes 21, 18, 13 and X.

Laboratories that participated in evaluation studies and have qualified Clarigo versus their internal prenatal reference method will be eligible to join the EAP. Multiplicom and the EAP-participants will closely work together to assure optimal results.

“Clarigo is an innovative non-invasive prenatal test offering local labs the prospective to reduce workload and overall cost to the level required to offer all interested pregnant women access to clinically relevant information of their fetus as an integral part of prenatal care” says Dirk Pollet, CEO of Multiplicom. “Our unique approach has a built-in accurate fetal fraction determination, and will simplify and streamline sample preparation, sequencing as well as the interpretation and reporting process providing consistent and high-confidence results.”

This proprietary offering is based on Multiplicom’s Multiplexer PCR technology and can be used in combination with any of the major massively parallel sequencing (MPS) platforms. Data analysis and reporting is performed using Multiplicom’s Clarigo Reporter-software that can be used as a stand-alone or cloud based solution.

The EAP will allow Multiplicom to generate a wealth of data in addition to the clinical validation study data that are being generated to meet the requirements of a CE-IVD kit.  Launch of the Clarigo Dx under the CE-IVD label is planned for early autumn, at which time the Clarigo-test will be broadly available.

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