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SQI Diagnostics Submits RALI-Dx; IL-6 Severity Triage Test for COVID-19 Patients to FDA for Emergency Use Authorization

with Confirmed COVID-19 Illness TORONTO, April 1, 2021 /PRNewswire/ - SQI Diagnostics Inc. (the Company or SQI ) (TSXV: SQD) (OTCQB: SQIDF), a precision medicine company that discovers, develops and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, announces that it has submitted its fully completed clinical and analytical data package to the U.S. Food and Drug Administration (FDA) for emergency use authorization (EUA) of its RALI-Dx ™ IL-6 Severity Triage Test. The submission was completed on March 31, 2021. The FDA will review the application under its pre-emergency use authorization (PEUA) process before a definitive EUA review. Subject to the acceptance of an EUA, the RALI-Dx

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Government Investments in Emerging Economies towards Healthcare Infrastructure Supports Prospects of Operating Room Equipment Study: Fact.MR

Published: Mar 17, 2021 Increasing preference for non-invasive surgical procedures will remain a key factor driving product development and commercialization in the operating room equipment market for the foreseeable future. Fact.MR, Dubai: Market research company Fact.MR’s ongoing operating room equipment market study has estimated strong growth in the coming decade, driven by increased emphasis being placed on sterile patient care environment. The covid-19 pandemic has generated significant growth opportunities in the industry owing to growing demand in severe cases through the crisis. The global healthcare sector is witnessing a transition from invasive to minimally invasive, and noninvasive procedures. Minimally invasive surgery, robotic surgery, image-guided procedures, and remote-surgery are expected to increasingly replace conventional surgical procedures.

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Ocugen to Seek EUA for India-Developed COVID-19 Vaccine in the United States

Published: Mar 17, 2021 By Alex Keown Pennsylvania-based Ocugen has struck a deal to sell 100 million doses of a COVID-19 vaccine India’s Bharat Biotech in the United States later this year. In an Reuters, Ocugen Chief Executive Officer Shankar Musunuri said it intends to launch the vaccine in the U.S. in the second quarter of this year, pending regulatory authorization. If the plan comes to fruition, the first doses will be imported from India and then subsequently manufactured in the U.S. by Ocugen. The two companies first announced plans for the deal in February. Ocugen and Bharat Biotech have been working together since December to develop COVAXIN, an advanced stage whole-viron inactivated vaccine. COVAXIN, a two-dose vaccine, has already received authorization in India for people ages 12 and above. In February, more than 30 million doses of COVAXIN had been administered to health professionals and front-line workers in India.

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Monocent Inc, Receives Authorization From COFEPRIS (Mexico) And INVIMA (Colombia), For Their US-Manufactured, CE Marked, Highly Accurate, Easy-To-Use, 15-Minute, COVID-19 Antigen Test

Published: Mar 17, 2021   CHATSWORTH, Calif., March 17, 2021 /PRNewswire/ Monocent Inc., (Monocent) is pleased to announce the COFEPRIS authorization of their SARS-CoV2 Antigen Rapid test System for detection of COVID-19 infection. The Monocent antigen test is a lateral flow test that provides results in just 15-minutes, without the use of any laboratory equipment. A collection of 3 rd party clinical evaluation studies from US, UK, Mexico, Columbia, India and China have shown the test to have 98% sensitivity and 100% specificity when compared to RT-PCR, making it ideal for large-scale, cost effective testing programs.  The Monocent Antigen Test is one component of Monocent s comprehensive COVID-19 testing solution. The test is paired with a complimentary, cutting-edge, HIPAA compliant technology platform, Rymedi. Rymedi s intuitive software will allow test administrators to securely send results to an individuals mobile wallet and display as a scannable QR code. Positiv

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CareDx Strengthens Bioinformatics Capabilities with Acquisition of BFS Molecular

Published: Mar 17, 2021 SOUTH SAN FRANCISCO, Calif., March 17, 2021 (GLOBE NEWSWIRE) CareDx, Inc.. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced it has acquired BFS Molecular S.R.L., a software company focused on NGS-based patient testing solutions. BFS Molecular brings extensive software and algorithm development capabilities for NGS transplant surveillance products that will add value to CareDx’s portfolio, including AlloSeq cfDNA and AlloSeq HCT. In addition to the acquisition of BFS Molecular, Tim Hague, CEO and Co-Founder of BFS Molecular, will join CareDx as Vice President of Global Lab Products Software. Mr. Hague was previously CEO of Omixon, a highly regarded innovator of NGS HLA typing solutions.

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