The age of precision medicine, with treatments targeted to specific patients based on a companion test identifying the need for such a treatment, is pushing the US Food and Drug Administration (FDA) to release new and more detailed draft guidance on how companies can co-develop a therapeutic alongside what the agency is calling an in vitro companion diagnostic device, or IVD companion diagnostic. The draft released Thursday, entitled "Principles for Codevelopment of an...

The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and  in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council and Parliament could adopt the two draft regulations by the end of 2...

The US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) on Friday invited industry, academia, and health care facilities to participate again in a program that helps train medical device review staff. The 2015 Experiential Learning Program (ELP) General Training Program, which was first launched in September 2011, is intended to provide CDRH staff with a better understanding of the policies, laboratory practices and challenges of t...

In advance of a hearing next Thursday, the House Energy & Commerce Committee has released a draft discussion bill that would set up new regulations for in vitro clinical tests. The 185-page draft bill lays out how it would create a new Center for In Vitro Clinical Tests within the US Food and Drug Administration (FDA). And although the bill refers to the tests as "in vitro clinical tests," it remains to be seen how FDA would regulate the tests differently from  in ...

All in vitro diagnostics (IVDs) for human use are medical devices. After that, it is easy to get lost in a seemingly foreign language of acronyms—ASRs, RUOs, LDTs and more. Can a company explain the differences between ASRs and LDTs—not to mention RUOs, IUOs, “home brew” tests and companion IVD diagnostics? How does it even begin to know into which category its new device will fall? The US Food and Drug Administration (FDA) has several good guidance doc...

A new guidance document issued by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) aims to clarify the regulatory processes by which certain molecular diagnostic devices are approved or cleared by federal regulators. Background As FDA explains in its guidance document, Molecular Diagnostic Instruments With Combined Functions , molecular diagnostic instruments are "critical components of certain in vitro diagnostic device...

Companion diagnostics offer a revolutionary approach for redefining the traditional fields of pharmacology and disease diagnostics. They support the drive toward personalized medicine by taking advantage of the wealth of information being derived from the human genome. In short, these diagnostic tools do not simply validate or confirm the presence of a genetic marker associated with a disease process but can offer wide-ranging benefits in improving the accuracy of therapy...

A new draft legislative report issued by a member of the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI), Peter Liese, would make significant changes to the manner in which in vitro diagnostic products are regulated in the EU. The proposal follows a landmark proposal issued on 15 April 2013 by another ENVI member, Dagmar Roth-Behrendt, which called for medical devices marketed in the EU to be subject to a premarket assessment syst...

A new draft guidance issued by the US Food and Drug Administration (FDA), Molecular Diagnostic Instruments with Combined Functions , aims to clarify the standards by which federal regulators will assess a particular subset of medical diagnostic tests. Background As FDA explains in its draft guidance document, molecular diagnostic instruments are "critical components of certain in vitro diagnostic devices (IVDs)." "These types of instruments are not generally approve...

Brazil's National Health Surveillance Agency (Anvisa) and the National Council for Scientific and Technological Development (CNPq) are partnering on an initiative to financially support projects that would "significantly contribute" to innovation in the regulatory sciences, Anivsa said in a 4 September announcement. Both CNPq -- a government agency that acts to promote science in technology in Brazil -- and Anvisa jointly  published on 31 August a public...