NEW YORK (360Dx) – The US Food and Drug Administration on Thursday released a Class 2 Device Recall notice on Exact Sciences Sample Mixer v2, used to mix stool samples in a container as part of preanalytic sample processing. The FDA said that Exact Sciences 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.
In a research note today, Canaccord Genuity research analyst Mark Massaro said that his firm spoke to a representative at Exact Sciences who confirmed that the issue has already been fixed and that the company "expects no impact to the business or test volumes in the quarter."
The Stago Group this week completed the acquisition of HemoSonics, a developer of point-of-care testing solutions, including the Quantra system, which employs sonic estimation of elasticity via resonance to characterize hemostasis and measure the evolving stiffness of forming blood clots. Financial and other terms of the deal were not disclosed.
Atomo Diagnostics announced that the Atomo HIV Self Test has received certification of registration from the Kenya Ministry of Health, 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.
Medley Genomics and the Lifespan Cancer Institute this week received a $50,000 innovation grant from Rhode Island. Medley has collaborated 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, based in Santa Fe Springs, California, develops, manufactures, and markets barcoded magnetic beads and detection systems for highly multiplexed nucleic acid or protein detection assays.
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. According to the Toronto-based company, while some AMD patients may benefit from such supplements, others may not, and some may even progress more rapidly to advanced AMD by using supplements.
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 announced that it has been named a Certified Service Provider of ArcherDX next-generation sequencing panels.
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