San Diego, CA, July 27, 2017 – Biomatrica, Inc. announced today that it has obtained CE-IVD marking for a suite of three sample collection tubes for use in several molecular diagnostic applications. Certified for in vitro diagnostic use in countries accepting the CE mark, these tubes enable non-invasive collection and preservation of a variety of biomarkers such as circulating or total nucleic acids, protein and cellular biomarkers.
The three products leverage Biomatrica’s expertise in preservation of complex biological samples during collection, transport and storage. LBgard® Blood provides robust preservation for cfDNA and targeted cells for liquid biopsy and non-invasive prenatal testing (NIPT). SalivaGardTM HT DNA provides superior DNA yield with an easy to use collection device for carrier screening, oncology and other next generation sequencing (NGS) based applications. RNAgard® Blood provides enhanced preservation of total nucleic acids in blood to evaluate gene expression and methylation biomarkers.
“This is an important milestone in our strategy to provide best-in-class collection products for diagnostic laboratories,” said Nick Ecos, Biomatrica’s President and CEO. “CE-marking provides assurance to our clients that we will be compliant with their regulatory standards.”
About Biomatrica, Inc.
Biomatrica, Inc. produces reagents and devices for collection, transportation, and long-
term storage of samples at the molecular and cellular level, with applications in
diagnostics, biobanking, and research. The company also embeds its chemistry inside
in vitro diagnostic kits produced by other companies, for diagnostics and genome sequencing, enabling transport and storage at ambient temperatures without the need for lyophilization. Its chemical formulations also position and dispense reagents inside clients’ kits and lab-on-chips to simplify use. The company’s products have been adopted by leading in vitro diagnostics producers, testing labs, and biobanks.