OCD’s “Know Your Numbers” campaign pushes forward
Ortho Clinical Diagnostics (OCD), in partnership with the National Association of Chronic Disease Directors (NACDD), published consumer-survey results and a report revealing the state of blood test health literacy in the United States, with strategies to support patient education and empowerment. Th
(February, 2012)
Industry associations discuss mutually important issues
Last October, the European Diagnostic Manufacturers Association (EDMA; Brussels) hosted the European IVD Forum 2011. The primary purpose of the forum was to facilitate discussions among high-level stakeholders on the challenges faced by healthcare systems. To this end, the forum was attended by memb
(January, 2012)
Sony Buys Micronics, Extends IVD Reach
Sony bought Micronics to boost its own R&D in the area of point-of-care diagnostic equipment and to accelerate commercialization of these products.
(January, 2012)
Examining IVD-related election year issues
The editors of IVD Technology asked industry analysts to share their thoughts and opinions on next year’s elections, the IVD-related issues that could be raised during the election year, and their potential impact on the IVD industry and IVD manufacturers.
(January, 2012)
Streamlining POC microfluidic molecular diagnostics
A family of microfluidic devices for nucleic acid-based tests incorporates such features as pouch-based fluid reservoirs and actuators, and on-chip pre-storage of controlled-release lyophilized reagents.
(December, 2011)
Extending the lifespan of IVD kits
Assessing the ability of various stabilizers to increase shelf-life, thereby maximizing usability and improving cost-efficiency.
(November, 2011)
IOM’s recommendation to replace 510(k) fails to win support
Back in late July of this year, the Institute of Medicine (IOM) recommended that FDA replace the 510(k) medical-device clearance process with something brand new. The committee stated that FDA’s resources would be better used in the development of a new framework using both premarket clear
(November, 2011)
Appeals court overturns ruling on gene patents
In the ongoing legal saga that could significantly affect the development of molecular diagnostics, the Federal Circuit Court of Appeals in Washington, DC partially reversed a lower district court’s earlier ruling in a case challenging patents on two human genes associated with breast and ovar
(November, 2011)
FDA releases guidance on companion diagnostics
FDA released its draft guidance on in vitro companion diagnostic devices. The guidance is intended to assist companies that are planning to develop a drug that depends on the use of a companion diagnostic for its safe and effective use as well as those companies that are planning to develop a co
(November, 2011)
Sidebar: How to Submit an Idea to GE’s Healthymagination Challenge
Submissions for the first challenge will close on November 20, 2011. All entries must include a clear, detailed proposal describing an innovative, original breast-cancer detection, diagnosis, or treatment technology or process.
Applicants should fill out the submission form (available online at htt
(October, 2011)
GE To Invest $1 Billion in Cancer R&D
GE announced this fall its plan to invest $1 billion during the next five years on R&D programs aimed at detecting, diagnosing, and treating cancer faster and more effectively.
(October, 2011)
The Year in IVDs
Reviewing a selection of the advanced new products and technologies that IVD manufacturers developed and launched in 2010-2011.
(October, 2011)
