Showing results for: In Vitro Diagnostic Articles & Analysis

Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has completed its clinical validation of an in vitro diagnostic (IVD) version of the ExoDx™ Prostate test (EPI) kit enabling self-certification as CE-IVD as of March 22, 2021. Bio-Techne Corporation (NASDAQ:TECH) today announced that Exosome Diagnostics, a Bio-Techne brand, has ...

By Exosome Diagnostics, Inc.

Company poised to disrupt $80 billion U.S. clinical laboratory market Chronus Health, a point-of-care diagnostics company, announced today that it has raised $22 million Series A financing led by Tarsadia Investments with participation from Monta Vista Capital, SOSV, Savantus Ventures, and an undisclosed strategic investor. While several on-site blood analyzers are already available in the ...

By Chronus Health, Inc.

As assay developers and clinical testing laboratories consider next steps for molecular diagnostics post-pandemic, a new in vitro diagnostic (IVD) system from Thermo Fisher Scientific will enable them to expand their assay menus and IVD testing capabilities moving forward. The Applied Biosystems QuantStudio 7 Pro Dx Real-Time PCR System is a compact instrument that easily transitions from ...

By Thermo Fisher Scientific

Protheragen, a dedicated preclinical research service provider specializing in rare diseases, announces its comprehensive diagnostic development services aimed at empowering researchers in the realm of rare disease research and drug development. These diagnostic services are designed to support the scientific community in identifying, understanding, and ultimately treating rare diseases that ...

By Protheragen

ELITechGroup Molecular Diagnostics announce today the CE-IVD marking of the CRE ELITe MGB kit, a high-performance, qualitative, multiplex assay for the rapid detection of the Carbapenem Resistance genes of Enterobacteriaceae. In combination with the ELITe InGenius™, the ELITech Group’s fully automated sample-to-result system, the assay is intended to detect 150 variants belonging to ...

By ELITechGroup

Abionic SA, the developer of proprietary disruptive nanotechnology based rapid diagnostic solutions, and Genentech, a member of the Roche Group, announced today a strategic agreement to develop and provide an In Vitro Diagnostic (IVD) Asthma Test Panel using Abionic’s POC abioSCOPE® platform in the United States. Abionic’s POC abioSCOPE®, a compact, ultra-fast medical device ...

By Abionic SA

Laboratoire Cerba and METAFORA biosystems are proud to announce the availability of the innovative test METAglut1 in routine biology to help diagnose the GLUT1 deficiency syndrome (GLUT1-DS) Laboratoire Cerba will perform the METAglut1 diagnostics test developed by METAFORA for the early non-invasive diagnosis of a debilitating neurological disease, the GLUT1 deficiency syndrome (also named De ...

By Metafora Biosystems

Specific Diagnostics today announces the opening of its European warehouse and servicing center in Amsterdam, Netherlands, to support its growing European operations. Working with global integrated logistics leader Crane Worldwide Logistics, Specific and its European subsidiary Specific Diagnostics Europe, Ltd., will warehouse Reveal® instruments and consumables in the Amsterdam facility. The ...

By Specific Diagnostics

On June 27, Alex Wittenberg at the Minneapolis/St. Paul Business Journal published a profile of Veravas, highlighting both its long-term potential in the billion-dollar IVD market and the upcoming launch of its first suite of products. “Veravas Inc., founded last year, says it's developed a novel technology with the potential to change the way conditions such as Alzheimer's and sleep apnea ...

By Veravas, Inc.

Specific Diagnostics today announced the appointment of Scott O’Brien as its Chief Commercial Officer. Mr. O’Brien is an industry veteran with over 20 years in molecular and infectious disease diagnostics, the last 10 at GenMark where he held a range of commercial positions, most recently Senior Vice President Global Marketing and International Sales at GenMark Diagnostics, ...

By Specific Diagnostics

Specific Diagnostics announces today the commencement of its US clinical studies for the Reveal Rapid AST System for blood infection. Trials will entail 3 months of data collection followed by submission for FDA consideration of 510(k) clearance of the Reveal test. In Europe, where the Reveal is launched under CE-IVD registration, 11 studies across France and England comprising over 1,400 ...

By Specific Diagnostics

Edinburgh Molecular Imaging (EM Imaging), the optical molecular imaging company, today announces the appointment of Dr Bernhard Sixt as Chief Executive Officer, effective immediately. Dr Sixt has 30 years of healthcare industry experience in the development and commercialisation of laboratory services, in vivo and in vitro diagnostics, and pharmaceuticals for industry leaders such as Amersham ...

By Edinburgh Molecular Imaging

BSI, the global standards and assessment body, has acquired German healthcare certification and testing business, EUROCAT. This development significantly enhances BSI’s ability to service the medical device market globally.EUROCAT is an established Notified Body offering healthcare systems and product certification. The company has a significant presence in Germany - the third largest medical ...

By BSI Consulting

Specific Diagnostics today announced formation of its US commercial sales, service, support and marketing teams in anticipation of the launch of the Reveal Rapid AST System for blood infection samples. Following 11 studies across France and England comprising over 1,400 clinical positive blood culture samples, yielding overall accuracy of 97.8%, and in tandem with the commencement of clinical and ...

By Specific Diagnostics

Specific Diagnostics today announced the appointment of David Barreca as Vice President of US Sales. David was a key member of GenMark’s sales leadership team, most recently a Senior Director managing a team of Account Executives that drove growth of the GenMark infectious disease diagnostics product, contributing the sales growth that led to GenMark’s acquisition by Roche Diagnostics ...

By Specific Diagnostics

Recently, Reetoo SARS-CoV-2 Antigen Rapid Self-test Kit (Colloidal Gold) received CE certification accredited by CeCert Sp. z o.o. and completed clinical validation in Vitalabo Laboratoria Medyczne Sp. z o.o. according to the latest EU guidance MDCG 2021-21 Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic, which means this product gained official access to the EU market. ...

By Shenzhen Reetoo Biotechnology Co.,Ltd

Billix has successfully completed the Series A round. It raised 14 billion won in an investment round in a year and a half. Not only financial investors (FI) but also strategic investors (SI) such as Estec Pharma and Soulbrain Holdings continued to participate. According to related industries on the 25th, Bilix recently completed attracting 14 billion won in Series A investment. As a result, the ...

By Bilix Co., Ltd.

Specific Diagnostics today announced the appointment of Nathan Clark as Strategic Account Director. Nathan was a key member of the GenMark sales leadership team, most recently as a sales manager for GenMark’s Northeast region, overseeing a team of 7 sales professionals and infectious disease specialists responsible for approximately $70M of revenue. Nathan was a critical part of the sales ...

By Specific Diagnostics

BSI Group America Inc., a leading provider of total solutions for certification and standards announces the launch of Specialized Regulatory Training courses targeted specifically for the medical device industry. Available on-site, these Specialized Regulatory Courses reflect requirements of the latest amendments to the Medical Device Directive enabling attendees to comply efficiently with ...

By BSI Consulting

Biocartis Group NV (the ‘Company’ or ‘Biocartis’), an innovative molecular diagnostics company (Euronext Brussels: BCART), today announced that its partner SkylineDx will present new data showing that its Merlin Test was able to prospectively reduce more than 37% of surgeries in a noninterventional study for newly diagnosed melanoma patients1 . The abstract publication ...

By Biocartis NV