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In Brief This Week: Qiagen, Novilytic, Akers Biosciences, and Applied Biocode

NEW YORK (360Dx) – Qiagen said this week that it has joined Cancer-ID, a public-private consortium that aims to establish standard protocols and clinical validation for blood-based biomarkers in lung and breast cancer.

With 36 partners from 13 countries, the Cancer-ID consortium is a project of the Innovative Medicines Initiative, a European public-private program that aims to speed up the development of better and safer medicines for patients.

Rapid advances in the use of liquid biopsies enable cancer treatment and monitoring through the identification of circulating tumor cells and tumor-related nucleic acids in blood samples. However, these advances have also highlighted the need for standardized methods and workflows to avoid unreliable or false analytical test results, including sequencing bias, Qiagen said.

Cancer-ID is developing standards and conducting clinical validation to enable broad adoption of reliable molecular analyses from liquid biopsies, Markus Sprenger-Haussels, a senior director in the life sciences business at Qiagen, said in a statement.

Purdue University said that the US Food and Drug Administration has registered as a Class 1 Medical Device a card-shaped device developed by Novilytic that collects drops of blood and separates out the plasma without the need for laboratory equipment. The device enables faster and more convenient collecting and processing of blood samples, Purdue said.

With the Class 1 medical device designation, medical diagnostic companies can use the device for plasma samples collected by doctors and others in medical facilities.

The Noviplex plasma collection card combines blood collection, plasma fractionation, sample preservation, transportation, and sample preparation into a single step. As plasma travels through a three-membrane stack, the technology separates and filters plasma from blood cells without power requirements.

The card "is the first major advance in blood collection in over 50 years,” Fred Regnier, a professor in Purdue’s College of Science and CEO of Novilytic, said in a statement, adding that the Noviplex cards effortlessly and consistently produce a stable plasma sample without the need for centrifugation.

Akers Biosciences announced a private placement to raise around $2 million. The firm said that it will use the proceeds from the transaction as growth capital and for general corporate purposes. It will issue 1,448,400 shares at a price of $1.40 per share, and 724,200 warrants with a strike price of $1.96 per share and a five-year term.

Applied BioCode said that it completed beta-site trials for an 18-plex gastrointestinal pathogen panel and its BioCode MDx 3000, an automated system that integrates all post-extraction processes of molecular diagnostics testing. The beta site trials were held at both the University of California, Los Angeles, and at the Poplar Healthcare Laboratory in Memphis, Tennessee, and were completed during January and February this year, the firm said.

Applied BioCode noted that it began shipping systems to clinical evaluation sites in March.

“We have tested our new investigational molecular diagnostics system in clinical laboratories and have gotten excellent feedback its diagnostic utility, Biocode president Winston Ho said in a statement.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on the 360Dx site.