NEW YORK (GenomeWeb) – The US Food and Drug Administration this week released a Class 2 Device Recall notice on Exact Sciences' Sample Mixer v2 used to mix stool samples in a sample container as part of pre-analytic sample processing. The FDA said that Exact sent an "urgent medical device correction" letter via email on April 28 to all affected consignees. The letter identified affected products and explained the issue, and the firm said that it would correct each unit, FDA said.
Horizon Discovery Group this week announced preliminary 2016 results, and said that it expected revenues would rise 19 percent to £24.1 million ($31.1 million) from £20.2 million in 2015. The firm said it would post a net loss of £11.4 million, or a loss of £.12 per share, from a loss of £9.9 million, or a loss of £.11 per share, in the prior year. The company also noted that it expects Q1 2017 revenues will rise 25 percent year over year, and said fiscal-year 2017 revenue guidance is between £30 million and £35 million.
Medley Genomics and the Lifespan Cancer Institute this week received a $50,000 innovation grant from the state of Rhode Island. Medley has partnered with Lifespan's Molecular Pathology Laboratories to advance clinical application of a new analytical approach to define genomic heterogeneity in patients' tumors. The collaborators will test software describing the complex evolution of tumor cell development, developed by Ben Raphael while at Brown University and exclusively licensed to Medley Genomics, in the clinical setting. The award will be used to finance acquisition and analysis of genomic data from primary and metastatic cancers for validation and publication. Medley Genomics will provide in-kind support for the program.
Applied BioCode said this week that it has received ISO 13485:2003 certification (FM 661595) from the British Standards Institution Group for the design, development, manufacture, and distribution of in vitro diagnostic reagents and in vitro medical devices used in molecular and protein detection. The company develops, manufactures, and markets barcoded magnetic beads and detection systems for highly multiplexed nucleic acid or protein detection assays.
Atomo Diagnostics announced that the Atomo HIV Self Test has received certification of registration from the Kenya Ministry of Health's Pharmacy and Poisons Board. The regulator recommends that the test be introduced into the market "to enable the national HIV testing program to benefit from its superior usability and in-field performance." The test detects antibodies to HIV-1 and HIV-2 in whole blood, and requires 10 microliters of blood from the fingertip to provide results in 15 minutes.
The Stago Group completed the acquisition of HemoSonics, a developer of POC testing solutions. HemoSonics' lead technology is the Quantra system, which leverages sonic estimation of elasticity via resonance technology to characterize hemostasis by measuring the evolving stiffness of forming blood clots. Financial and other terms of the deal were not disclosed.
Arctic Diagnostics said its Vita Risk test has been approved for reimbursement by Medicare contractor Palmetto GBA. The test determines whether a patient with age-related macular degeneration may benefit from taking eye vitamin supplements.
The National Cancer Institute Clinical Proteomic Tumor Analysis Consortium has joined the Panorama Partners Program, a collaboration of proteomics-focused organization organized by LabKey and the MacCoss Lab at the University of Washington. The program helps fund and direct development of the open-source proteomic data management tool called Panorama.
Helomics announced this week that it has made an agreement with the Pittsburgh Life Sciences Greenhouse to form an incubator dedicated to diagnostics and precision medicine.
MolecularMD said this week that it has been named a Certified Service Provider of ArcherDX next-generation sequencing panels.
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 GenomeWeb site.