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In Brief This Week: Danaher, Exact Sciences, Fluidigm, Arrow Diagnostics, and More

NEW YORK – China's General Administration of Market Supervision announced this week that it has approved Danaher's proposed $21.4 billion acquisition of GE's Biopharma businessThe decision follows last year's EU approval of the deal, leaving the US Federal Trade Commission as the last regulatory body to comment on the deal before it can close.

Fluidigm said in a filing with the US Securities and Exchange Commission that it has entered into an open market sales agreement with Jefferies through which it may offer and sell shares of its common stock from time to time for an aggregate offering price of up to $50 million. Jefferies will act as the agent for the sale of any stock and will receive a 3 percent commission. Fluidigm said it plans to use the net proceeds for general corporate purposes and working capital. It also said it may use a portion of the proceeds to fund possible investments in or acquisitions of complementary businesses, products, or technologies.

Exact Sciences said this week that it has completed its previously announced acquisitions of Paradigm Diagnostics and Viomics, two privately held companies based in Phoenix, ArizonaExact announced the acquisitions during its fourth quarter earnings call in February. Paradigm and Viomics will remain based in Phoenix, the company said. Financial terms of the transactions are not being disclosed.

Arrow Diagnostics said this week that it has received the CE mark for two library preparation kits for bacterial 16S rRNA gene sequencing. The kits, AD4SEQ Microbiota Solution A and B (formerly called ArrowforNGS Microbiota Solution A and B), amplify the 16S hypervariable regions V1-V2-V3 and V3-V4-V6, respectively. They are designed to be used with the Illumina MiSeq sequencer and come with dedicated analysis and reporting software, MicrobAT.

Roche said this week that the US Food and Drug Administration has granted breakthrough device designation to the company's Elecsys Galad score. The algorithmic score combines patient gender and age, as well as the results of Roche's Elecsys test for biomarkers AFP, AFP-L3, and PIVKA-II to aid in the diagnosis of early-stage hepatocellular carcinoma. Combined with ultrasound, the Elecsys Galad score can give clinicians accurate information at an earlier stage about a patient's disease, improving patient outcome and potentially reducing costs to healthcare systems, Roche said.

Kiyatec said this week that the VA Portland Health Care System has joined the company's 3D-PREDICT clinical study to validate Kiyatec’s test as a patient-specific predictor of response to cancer therapies in glioblastoma patients. 3D-PREDICT is a prospective, open-label, non-interventional study to validate Kiyatec's glioblastoma drug response profile, which uses an ex vivo 3D cell culture platform to assess pre-treatment, patient-specific response to a panel of 12 drugs most commonly used to treat the disease.

Assistance Publique-Hôpitaux de Paris (AP-HP) and Median Technologies this week inked a collaboration agreement involving studies to validate Median’s iBiopsy platform, which consists of artificial intelligence-based qualification of diagnostic and prognostic imaging biomarkers. The agreement initially covers two joint clinical studies on liver cancer, involving coordinating investigators at Median and two AP-HP hospitals ─ Pitié-Salpêtrière and Paul-Brousse. 

The first study aims to use medical imaging to identify the phenotypic heterogeneity of liver cancer and its impact on the diagnosis and prognosis of patients. The second study will use retrospective data from a smaller and more targeted patient cohort to identify phenotypes of high-risk liver tumor recurrence, to improve the treatment and follow-up of high-risk patients.

Chembio Diagnostics this week provided an update on its application to the US Food and Drug Administration for premarket approval of its DPP HIV-Syphilis Assay System. Chembio said that the FDA has confirmed that the syphilis arm of the study and results associated with the inclusion of pregnant women were acceptable. However, the FDA has requested the repeat of a reproducibility study, as one of the sites in the trial reported greater variability compared to the other sites.  

Chembio said it has addressed and discussed with the FDA what it deems to be the underlying cause of the variance, and it has already initiated the reproducibility study. In parallel, the company has accelerated studies for a CLIA waiver for the test.

Sophia Genetics said this week that it will open a North American R&D hub in Aurora, Colorado, after receiving approval for a job-growth tax credit from the Colorado Office of Economic Development & International Trade. The Swiss bioinformatics firm expects to have 100 employees in the new facility by 2022. Recruitment will start with an event in Denver from March 30 to April 3.

CN Bio Innovations announced this week that it has raised $9 million in an investment round led by CITIC Securities Investment and supported by existing investor CN Innovations Holdings. The funding will be used to support commercial development and strengthen CN Bio's position in the US market, whilst also expanding its operations across Europe. The company will also use this funding to help drive sales of its products and services, including the PhysioMimix platform. 

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