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QIAGEN receives U.S. FDA approval for cytomegalovirus (CMV) testing on automated QIAsymphony

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QIAGEN (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received premarket approval from the U.S. Food and Drug Administration (FDA) for its automated artus® CMV QS-RGQ MDx kit for use on QIAGEN’s QIAsymphony platform, providing fast, reproducible, high-quality test results for use as an aid in the management of solid organ transplant patients who are undergoing anti-CMV therapy.

Patients who have undergone organ transplantation have an elevated risk of infection from CMV, which is a common virus that infects people of all ages. Over half of all adults by age 40 have been infected with CMV, according to the U.S. Centers for Disease Control (CDC). Once CMV is in a person’s body, it stays there for life in latent form and can reactivate.

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QIAGEN Expands Biomarker Content Portfolio to Support Molecular Diagnostics for Immuno-Oncology Therapies

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QIAGEN has announced it has received a worldwide license from The Johns Hopkins University for biomarkers that have been shown to play key roles in identifying patients who could benefit from novel immune-oncology (I-O) therapies in cancer treatment.

The agreement involves rights to genetic biomarkers to assess microsatellite instability (MSI) and mismatch repair (MMR) in all sample and cell types, and will enable QIAGEN – subject to its exercising certain option rights – to commercialize molecular testing solutions using next-generation sequencing to assess MSI and MMR status. Levels of MSI and MMR, along with tumor mutation burden (TMB), are important in identifying cancer patients who could benefit from certain types of I-O therapies, which offer a novel way to treat cancer by using drugs to target the body’s immune system to help fight cancer.

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A CAUTIOUS RESTRUCTURING OF THE ANGEL MARKET IN 2016 WITH A ROBUST APPETITE FOR SEED AND START-UP INVESTING

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The angel investor market in 2016 experienced a decrease in investment dollars and in the deal size. Total investments in 2016 were $21.3 billion, a decrease of 13.5% over 2015, according to the Center for Venture Research at the University of New Hampshire. A total of 64,380 entrepreneurial ventures received angel funding in 2016, a decline of 9.5% over 2015 investments. The number of active investors in 2016 was 297,880 individuals, a decrease of 2.3% from 2015. The change in both total dollars and the number of investments resulted in a deal size for 2016 that was smaller than in 2015. While these data indicate a cautious retreat in terms of dollars invested and deals, angels increased their appetite for seed and start-up investing, and the associated risk, but with a higher perceived value as demonstrated by the increase in valuations and decrease in deal (investment round) size.

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FDA Launches Digital Health Unit – Medpage Today

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The FDA’s Center for Devices and Radiological Health is ramping up medical app and device offerings with a recently announced digital health unit.

The aim of this development is to centralize and coordinate digital health information so that there is consistency in applying policies. According to the associate director of digital health for the FDA, Bakul Patel, the primary responsibilities of those on the project will be to develop software and digital health tech to assist with premarket submissions or devices, utilize experts, and incorporate metrics that will aid review times and submissions.

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Biotech close to diabetes breakthrough – Innovators magazine

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A vaccine that could provide a major breakthrough in the fight against Type 1 diabetes is to be tested in human trials.

Developed by Belgian biotech Imcyse, in collaboration with the French National Institute of Health and Medical Research (INSERM) in Paris – and 18 clinical sites across Europe, the company’s Imotopes™ technology can destroy immune cells that kill insulin-producing cells.

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7 Reasons To Join Business Incubators – HuffPost

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As an entrepreneur, I spent over three years in two different startup incubators – Brazil’s Genesis Institute, part of PUC-Rio’s university, and Maryland’s Rockville Innovation Center, run by Montgomery County’s Economic Development Department. As mentor, I have also had the opportunity to coach several incubated companies, from incubators like 1776 and beyond. I could experience firsthand the benefits of business incubation, which can be significant for early-stage entrepreneurs.

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