Global BioClinical

Global BioClinical (GBC) are Boudicca DX are Partners!

GBC Partners with Boudicca DX to become a one stop global shop for STRATEGY and EX*****ON for Medical Device 🩻 & In Vitro Diagnostic 🧬 Companies saving them ⏰ & 💰!

See press release here:

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Imagine the thrill of discovery when more than 10 years of research on the origin of a common genetic disease, cystic fibrosis (CF), results in tracing it to a group of distinct but mysterious Europeans who lived about 5,000 years ago. CF is the most common, potentially lethal, inherited disease among Caucasians – about one in 40 carry the so-called F508del mutation. [ 2,171 more words ]

Discovering the Ancient Origin of Cystic Fibrosis, The Most Common Genetic Disease in Caucasians Imagine the thrill of discovery when more than 10 years of research on the origin of a common genetic disease, cystic fibrosis (CF), results in tracing it to a group of distinct but mysterious Euro…

ARESupa test aims at broad detection of microbial infections employing next-generation sequencing and artificial intelligence Curetis explores venture capital (VC) funding for Ares Genetics while assessing all strategic and tactical financing options for growth of Unyvero core business Amsterdam, the Netherlands, Holzgerlingen, Germany, and Vienna, Austria, September 04, 2018, 01:00 am EST - Curetis N.V. (the "Company" and, together with its subsidiaries, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced that its wholly-owned subsidiary Ares Genetics GmbH (“Ares Genetics”) has initiated the development of its ARESupa Universal Pathogenome Assay. [ 1,166 more word ]

Curetis’ Subsidiary Ares Genetics Initiates Development of AI-Powered Infectious Disease Test ARESupa test aims at broad detection of microbial infections employing next-generation sequencing and artificial intelligence Curetis explores venture capital (VC) funding for Ares Genetics while a…

Aug 08, 2018 NEW YORK (GenomeWeb) — Epigenomics reported today an 88 percent year-over-year increase in second quarter revenues amid strong growth in product sales and higher licensing income. For the three-month period ended June 30, Epigenomics' revenues rose to €462,000 ($535,912) from €246,000 in the same period last year. Product sales — which include the company's US Food and Drug Administration-approved Epi proColon blood-based colorectal cancer screening test — were up nearly 66 percent to €250,000 from €151,000. [ 241 more words ]

Epigenomics Posts 88 Percent Increase in Q2 Revenues Aug 08, 2018 NEW YORK (GenomeWeb) — Epigenomics reported today an 88 percent year-over-year increase in second quarter revenues amid strong growth in product sales and higher licensing income. For…

WELCOME TO THE NEW ERA OF MEDICINE Finding lifesaving treatments is our life’s work—the work of the 140,000 biopharmaceutical researchers who boldly leap into the unknown to pioneer tomorrow’s breakthrough cures. It’s also the work of millions of patients who fight against whatever obstacles they face.

The New Era of Medicine (www.innovation.org) WELCOME TO THE NEW ERA OF MEDICINE Finding lifesaving treatments is our life’s work—the work of the 140,000 biopharmaceutical researchers who boldly leap into the unknown to pioneer tomorrow’s brea…

Seattle’s Integrated Diagnostics Acquired by Lung Cancer Technology Company Biodesix Colorado-based Biodesix, a company that creates technology around lung cancer, announced that it has acquired Seattle’s Integrated Diagnostics for an undisclosed sum. Integrated Diagnostics, also known as Indi, develops a test that can rule out patients who do not have lung cancer using a simple blood draw, a less invasive and more cost-effective option than the traditional lung biopsy. [ 190 more words ]

Seattle’s INDI Acquired by Lung Cancer Tech Company Biodesix Seattle’s Integrated Diagnostics Acquired by Lung Cancer Technology Company Biodesix Colorado-based Biodesix, a company that creates technology around lung cancer, announced that it has acquired Se…

Clara Rodríguez Fernández on 3-July-2018 Antimicrobial resistance is predicted to kill more people than cancer by 2050. Is it possible to prevent it? At our Refresh Meetup in Berlin, I talked with Achim Plum, CBO of the diagnostics company Curetis, about what are our best bets to turn the tables in the fight against the threat of antimicrobial resistance. The discovery of antibiotics changed medicine forever. [ 1,432 more word ]

Fighting Antimicrobial Resistance with Fast Molecular Diagnostics Clara Rodríguez Fernández on 3-July-2018 Antimicrobial resistance is predicted to kill more people than cancer by 2050. Is it possible to prevent it? At our Refresh Meetup in Berlin, I talked with …

- Epigenomics plans to CE Mark mSEPT9 blood test for liver cancer by year-end 2018, enabling commercialization in Europe - Prospective U.S. trial for FDA submission to be initiated in 2019 - Investigating optimal path for CFDA approval in China Berlin (Germany) and San Diego, CA (U.S.A.), July 2, 2018 - Epigenomics AG (FSE: ECX, OTCQX: EPGNY) today announced it's plan to CE Mark mSEPT9 blood test by year-end 2018 to aid in detecting liver cancer among patients with cirrhosis. [ 389 more words ]

Epigenomics AG: Liquid Biopsy Test for Liver Cancer Detection to obtain CE Mark – Epigenomics plans to CE Mark mSEPT9 blood test for liver cancer by year-end 2018, enabling commercialization in Europe – Prospective U.S. trial for FDA submission to be initiated in 2…

HHS Delays Common Rule for Another Six Months June 19, 2018 Delays are becoming commonplace when it comes to the Common Rule. The U.S. Department of Health and Human Services (HHS) just announced it is delaying, again, rollout of the revised Common Rule on the protection of human subjects in clinical trials for six months—until January 21, 2019. HHS is also granting an exception from the existing federal policy for three burden-reducing provisions during the delay period. [ 320 more words ]

HHS Delays Common Rule for Another Six Months HHS Delays Common Rule for Another Six Months June 19, 2018 Delays are becoming commonplace when it comes to the Common Rule. The U.S. Department of Health and Human Services (HHS) just announced i…

UTI panel covers 103 diagnostic targets 443-patient multi-center study demonstrates overall weighted average sensitivity of 95.6% at an overall weighted average specificity of 99.3%. Amsterdam, the Netherlands; San Diego, CA, USA; and Holzgerlingen, Germany; April 19, 2018, 01:00 EDT -- Curetis N.V. (the "Company" and, together with Curetis USA Inc. and Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, today announced the successful completion of clinical performance evaluation and CE-IVD marking of its novel Unyvero Application Cartridge, UTI, for the diagnosis of severe urinary tract infections. [ 1,068 more word ]

Curetis Launches CE-IVD Marked Unyvero Urinary Tract Infection (UTI) Cartridge UTI panel covers 103 diagnostic targets 443-patient multi-center study demonstrates overall weighted average sensitivity of 95.6% at an overall weighted average specificity of 99.3%. Amsterdam, th…

- First ever multiplex MDx test to be granted clearance by the FDA for this indication - Commercial launch in the U.S. expected this quarter Amsterdam, the Netherlands, San Diego, CA, USA, and Holzgerlingen, Germany, April 03, 2018, 15:45 am EDT - Curetis N.V. (the "Company" and, together with Curetis USA Inc. and Curetis GmbH, "Curetis"), a developer of next-level molecular diagnostic solutions, announced today that the Company has been granted a De Novo clearance by the U.S. [ 1,296 more word ]

Curetis Receives U.S. FDA De Novo Clearance of Unyvero System and Unyvero LRT Lower Respiratory Tract Infection Cartridge – First ever multiplex MDx test to be granted clearance by the FDA for this indication – Commercial launch in the U.S. expected this quarter Amsterdam, the Netherlands, San Diego, CA, U…