NEW YORK (360Dx) – The Federal Trade Commission said today that Becton Dickinson and CR Bard have agreed to divest two medical device product lines to settle its complaint that the proposed $24-billion acquisition would negatively impact competition.
Under the settlement, BD will divest its soft tissue core-needle biopsy product line and CR Bard will divest its Aspira product line of tunneled home drainage catheters and accessories.
Vincent Forlenza, BD chairman and CEO, said in a statement that the firm expects that the acquisition will close in December, pending approval by the Ministry of Commerce of the People's Republic of China and the satisfaction of customary closing conditions.
In April, BD entered an agreement to acquire CR Bard for $317.00 per share in cash and stock.
Co-Diagnostics said this week that it is leasing a new and upgraded laboratory in Salt Lake City that meets Current Good Manufacturing Practices (CGMP), which are enforced by the US Food and Drug Administration, and has Biological Safety Level 2 (BSL-2) capabilities that enable "enhanced in-house verification and validation activities."
Co-Diagnostics CEO Dwight Egan said that the upgraded facility "is nearly perfectly appointed with the necessary amenities to immediately commence production operations."
He noted that the site will help the firm reduce its dependence on outside locations to complete validations of the company’s products, and that it represents the next step in its growth as a developer of molecular diagnostics.
HTG Molecular Diagnostics and Qiagen have amended a first statement of work under a previously announced master assay development, commercialization, and manufacturing agreement, HTG disclosed in a filing with the US Securities and Exchange Commission.
The first statement of work, dated June 14, 2017, relates to the development and use of a next-generation sequencing-based clinical trial assay that is the subject of a project agreement between Qiagen and a pharmaceutical company. Initial-phased development activities under the first statement of work are complete, and the amendment relates to next-phase development activities.
Qiagen has agreed to pay HTG low, single-digit millions of dollars in development fees for these activities, which are expected to be completed in early Q1 2018. In addition, HTG and Qiagen will share any incremental net profits generated as a result of the activities. Successful completion of the next-phase activities is expected to lead to further project development activities and potential commercialization of a companion diagnostic assay for a drug.
Clinical Genomics Pathology has received lab accreditation from the College of American pathologists. The lab offers Clinical Genomics' Colvera liquid biopsy ctDNA assay, which is used to detect residual disease and recurrent disease in patients previously diagnosed with colorectal cancer. The test is designed to detect the presence of epigenetic modifications of two genes — BCAT1 and IKZF1 — using PCR technology and reagents from Qiagen.
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.