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In Brief This Week: Qiagen, Thermo Fisher Scientific, Nightingale Health, and More

NEW YORK (360Dx) – The International Panel Physicians Association has endorsed Qiagen's QuantiFeron-TB Gold Plus test for immigration medical screening for latent tuberculosis. IPPA is a not-for-profit physician education group that works with nations receiving immigrants and refugees. Panel physicians are appointed by receiving country governments to handle the mandatory pre-departure medical exams of migrants and will be required to use interferon gamma release assays (IGRA), such as the QuantiFeron-TB Gold Plus, for TB screening, Qiagen said.

Oxford Immunotec also offers an IGRA test, the T-Spot.TB test. Neither the company nor IPPA replied to questions about whether that test has received IPPA endorsement.

The IPPA endorsement follows a decision last month by the World Health Organization deeming IGRAs an appropriate alternative to tuberculin skin testing for determining which patients in regions with a high disease burden could progress to active TB. The CDC also mandated last month all US civil surgeons screening immigrants for latent TB to use IGRAs instead of tuberculin skin tests.

Thermo Fisher Scientific said that Charité–Universitätsmedizin Berlin of Germany has joined its Next-Generation Sequencing Companion Dx Center of Excellence Program, which aims to establish research collaborations and drive the adoption of Thermo Fisher's Oncomine assays for clinical applications.

Under the agreement, Michael Hummel, professor at the Institute of Pathology at Charité, will lead research studies using Oncomine immune-oncology and liquid biopsy assays, as well as Thermo Fisher’s sequencing platforms. Charité's molecular diagnostics unit already offers Thermo Fisher's amplicon-based NGS tests for patient care and Charité has collaborated with the company on product development projects in the past.

Nightingale Health will analyze 40,000 blood samples from Finland’s THL Biobank as part of the company’s goal of bringing personalized medicine to Finnish healthcare. In a statement, Nightingale Founder and Scientific Director Peter Würtz said that analyzing the samples with its biomarker testing technology “allows us to capture detailed biological differences between patient groups,” which will translate into improved prediction of heart disease and other chronic ailments. The company’s technology is based on nuclear magnetic resonance spectroscopy. It moved into the clinical space last year. Earlier this month, Nightingale announced a precision medicine collaboration with PerkinElmer.

Invitae said that in connection with a recent arrangement with Oxford Finance to extend its loan and security agreement by an additional $20 million, the company granted the lender warrants to purchase 55,563 shares and 29,919 shares of Invitae’s common stock at an exercise price of $7.02 per share. The warrants have a term of 10 years from the date they were issued and include a cashless exercise provision.

Sygnis has restructured its sales and marketing operations to drive continued strong revenue growth. A direct sales and distribution team has been created to focus on product sales, while a business development team will concentrate on partnering and service opportunities. Marketing will support both teams and be responsible for maintaining the newly launched Expedeon-branded product website.

Sygnis also said that in 2017, revenues are anticipated to grow to €7.8 million ($9.6 million) from €1.8 million in 2016. Organically, revenues are expected to record a 24 percent year-over-year growth rate, while the number of employees has also risen to more than 30.

VolitionRx has closed its public offering of 3.5 million shares of its common stock at $2.40 per share. Gross proceeds from the offering were $8.4 million. The company intends to use the proceeds for continued product development, clinical studies, product commercialization, working capital, and other general corporate purposes.

Fluidigm said this week that it has entered into separate privately negotiated transactions to exchange approximately $25.0 million in aggregate principal amount of its existing 2.75 percent convertible senior notes due 2034 for about $25.0 million in aggregate principal amount of additional 2.75 percent exchange convertible senior notes due 2034. The additional exchange notes, together with $125.0 million of exchange notes previously sold on March 6, 2018, will form a single class of $150.0 million principal amount of the exchange notes. Following the closing of the exchange, Fluidigm anticipates that $51.3 million in aggregate principal amount of existing notes will remain outstanding.

Inivata announced that MedStar and the MedStar Georgetown Cancer Institute will join the Inivata Knowledge Accumulation Network (IKAN), a global network of cancer centers working to assess the potential of liquid biopsy and circulating tumor DNA analysis. MedStar will join Atrium Health's Levine Cancer Institute and West Cancer Center as the pioneering members of IKAN, Inivata said.

Infectious disease diagnostics firm 3i Diagnostics said its Biospectrix platform has been granted breakthrough device designation by the US Food and Drug Administration. The FDA program is intended to accelerate the development and review of diagnostics and devices that demonstrate the ability to address unmet medical needs for life-threatening or irreversibly debilitating diseases.

Biospectrix detects and identifies microbes from whole blood within one hour using a pressure driven, selective lysis process that isolates bacteria and eliminates the need for culturing, according to 3i Diagnostics’ website.

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.