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In Brief This Week: FDA, Bio-Rad, Twist Bioscience, and More

NEW YORK – The US Food and Drug Administration this week issued a final rule requiring that medical device premarket submissions be sent in electronic format, eliminating the need for multiple paper submissions. The FDA said that with this final rule, it was taking action to improve the efficiency of its premarket submission program.

Bio-Rad Laboratories this week moved a lawsuit alleging patent infringement by 10x Genomics to the US District Court for the District of Massachusetts.

The suit, filed Sept. 11— on the eve of 10x Genomics' initial public offering — alleged that 10x's new line of Next GEM microfluidic chips infringed US Patent No. 8,871,444, licensed by Bio-Rad from Harvard University and the UK's Medical Research Council, among other patents. The firm refiled the case because 10x had objected to the original venue of the US District Court for the District of Delaware.

Twist Bioscience has entered into an agreement with Cowen and Company to sell up to $50 million in stock, the company said this week in a filing with the US Securities and Exchange Commission.

Under the terms of the agreement, Cowen will act as sales agent. Twist will set the parameters for the sale of shares, including the number of shares to be issued, the time period during which sales are requested to be made, limitations on the number of shares that may be sold in any one trading day, and any minimum price below which sales may not be made. Twist will pay Cowen a commission of 3 percent of gross proceeds. Other details were not disclosed.

The deal follows a shelf registration Twist filed with the SEC in November to sell up to $200 million in stock. The firm went public in October 2018 with an initial $86.3 million offering. In May, it raised an additional $84 million in a public offering.

The New York Genome Center said this week that Hackensack Meridian Health of New Jersey and the Georgetown Lombardi Comprehensive Cancer Center of Washington DC have become NYGC institutional associate members, bringing the total number of such associate members to seven.

Both institutions will participate in NYGC's Genome Center Cancer Group. In addition, Hackensack Meridian Health's Center for Discovery and Innovation will engage in NYGC's Neuropsychiatric Disease Scientific Working Group. Hackensack Meridian Health CDI will be leading a partnership to explore genetic risk factors for behavioral disorders and genetic markers that can help predict and manage them. Georgetown Lombardi Comprehensive Cancer Center is leading a project to study genetic risk factors of aggressive cancers, such as pediatric brain tumors; understand why cancers fail to respond to immunotherapy; and identify genetic markers or cellular factors that can improve patient outcomes.

Genomind and Albertsons Companies said this week that they are expanding their partnership to offer patients genetic testing at more locations.

The companies originally partnered in June 2018 to allow pharmacy patients at select Albertsons, Jewel-Osco, and Acme supermarkets to voluntarily receive free education about Genomind's Genecept Assay, the genetic test designed to help clinicians optimize treatment decisions for their patients dealing with mental health issues.

Now, specially trained pharmacists in all Acme pharmacies in Pennsylvania and select Albertsons pharmacies in Idaho will offer the Genomind Professional PGx Express genetic testing service to guide mental health medication management. Pharmacists will also have access to G-DIG, Genomind's proprietary software system with updated information on how drugs may interact with patient genotypes and other drugs.

Castle Biosciences announced this week that it will be added to the Nasdaq Biotechnology Index, effective prior to the opening of the market on Dec. 23, 2019. Companies in the Nasdaq Biotechnology Index must meet eligibility requirements, including minimum market capitalization and average daily trading volume, among other criteria, Castle said. The company also noted that it was also included in the US small-cap Russell 2000 Index in 2019.

Expedeon announced this week that all management proposals were approved at its general meeting in Heidelberg by a large majority and without objection. The meeting was held to seek shareholder approval for the sale and purchase agreement with Abcam, with respect to the sale of Expedeon's proteomics and immunology business for €120 million, which it announced in November. Shareholders also approved a measure to change the company's name to 4basebio, reflecting its new focus on DNA manufacturing for gene therapy and gene vaccines.

Abbott announced this week that it raised its quarterly common dividend 12.5 percent to $.36 per share. The cash dividend is payable Feb. 14, 2020, to shareholders of record at the close of business on Jan. 15, 2020.

Bio-Techne this week announced that its Exosome Diagnostics laboratory has received accreditation from the College of American Pathologists based on the results of a recent on-site inspection. The firm noted that the CAP accreditation comes on the heels of CLIA, ISO 13485, and New York state certifications already awarded to the firm for its laboratory in Waltham, Massachusetts.

MedGenome Labs said this week it has been re-accredited by the College of American Pathologists. The CAP checklist covers clinical pathology, anatomic pathology, cytopathology, molecular pathology and other disciplines, along with overall management and operation of the medical lab, the Indian company said.

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.