Algorithmic Biologics, a deep-tech startup building algorithms for molecular programming, today announced that it has received ConformiteEuropeene (CE) Mark approval for its proprietary compressed molecular testing method called Tapestry, for In-Vitro Diagnostics (IVD).
Tapestry was earlier cleared for commercial deployment by the Drugs Controller General of India and is being used to affordably screen large populations for Covid using RT-qPCR. It was the only Indian product to reach XPrize finals for Rapid Covid Testing. It has since been extended to support other molecular tests and Algorithmic Biologics is working on establishing partnerships to extend the benefits to other life-saving tests like newborn screening, HIV, liquid biopsy etc. "We are very pleased to report CE Mark approval for Tapestry, as we continue to expand our molecular programming platform to IVD tests beyond Covid, and diversify our revenue across markets and procedures. This CE certification is an essential regulatory milestone on our road to commercialization in the European Union and other CE Mark geographies," said Manoj Gopalkrishnan, Founder and CEO at Algorithmic Biologics. "The CE mark on our innovative product Tapestry represents the culmination of years of work and demonstrates that Algorithmic Biologics has the capability to develop algorithmic products that meet performance, quality and safety requirements in the EU." Tapestry's platform technology works like a compression algorithm for molecular testing not just in healthcare, but also in pharmaceuticals, agriculture, animal husbandry, food safety, synthetic biology, and molecular biology research. A CE mark indicates the Tapestry software complies with Directives of the European Commission (EC) and therefore can be marketed within the 31-nation European Economic Area (EEA) and Switzerland. The certification involved a comprehensive audit of the company's quality system, as well as thorough evaluation of Tapestry to assure it performs safely and as designed.
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( With inputs from ANI )
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