Trends & Perspectives
Creation of Genetic Testing Registry is underway
The National Institutes of Health (NIH) announced in March that it is creating a public database of genetic tests. Researchers, consumers, healthcare providers, and others will have access to the Genetic Testing Registry (GTR) to search for information submitted voluntarily by genetic test providers.
 
NIH director Francis...
FDA meeting on BGMs successful, productive

 FDA held a public meeting on blood glucose meters in March of this year; the agency is very pleased with the level of discussion and input that was generated at the meeting. 

Courtney Harper, director of the division of chemistry and toxicology devices at CDRH, the division that hosted the meeting, cited 12,000 measurement errors reported each year by users...
FDA Meetings on BGMs Successful, Productive

 FDA held a public meeting on blood glucose meters in March of this year; the agency is very pleased with the level of discussion and input that was generated at the meeting. 

Courtney Harper, director of the division of chemistry and toxicology devices at CDRH, the division that hosted the meeting, cited 12,000 measurement errors reported each year by users of blood glucose meters (BGMs) and said that the meeting was “a way for FDA to try to take a new approach...
Creation of Genetic Testing Registry Is Underway

The National Institutes of Health (NIH) announced in March that it is creating a public database of genetic tests. Researchers, consumers, healthcare providers, and others will have access to the Genetic Testing Registry (GTR) to search for information submitted voluntarily by genetic test providers.

NIH director Francis Collins’s chief of staff,...
FDA Meetings on BGMs Successful, Productive

 FDA held a public meeting on blood glucose meters in March of this year; the agency is very pleased with the level of discussion and input that was generated at the meeting. 

Courtney Harper, director of the division of chemistry and toxicology devices at CDRH, the division that hosted the meeting, cited 12,000 measurement errors reported each year by users of blood glucose meters (BGMs) and said that the meeting was “a way for FDA to try to take a new approach...
Challenges for comparative effectiveness research in IVDs

The recently passed healthcare reform legislation implemented various provisions related to comparative effectiveness research (CER), including a section that created an independent, nonprofit organization, the Patient-Centered Outcomes Research Institute. This institute will be charged with conducting research that informs the public and healthcare providers about the comparative risks and benefits of marketed drugs, devices, and medical products.

According to the legislation, the...

Radiological devices oversight moves to OIVD

The Gray Sheet reported that FDA Commissioner Margaret Hamburg signed the orders that officially moved the Radiological Devices Branch from the Office of Device Evaluation (ODE) to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). FDA hopes that doing so will produce more cohesive policies on diagnostic device review. Issues under the jurisdiction of the radiological branch, which regulates diagnostic imaging equipment and other radiation-emitting devices, have been a...

SACGHS draft report finds gene patents unhelpful

The Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS) in February released a revised draft report on gene patents and licensing practices and their impact on patient access to genetic tests. The report will be sent to Secretary of Health and Human Services Kathleen Sebelius upon completion.

The draft document seeks to determine the effects of patents and licensing on the development of genetic tests, as well as analyze other possible patenting and...
New venture capital fund established for biotech

A $550-million venture capital fund has been established by OrbiMed Advisors LLC to invest in healthcare technology. The firm is looking to invest across the healthcare market, including diagnostics. “We are very interested in the diagnostic space,” says Carl Gordon, a founding partner at OrbiMed. “Looking forward to our fourth fund, diagnostics is going to be an important element of investment for us.” Gordon says the funds’ investors are also “extremely...

Merck Group buys Millipore

Merck KGaA (Darmstadt, Germany) and Millipore Corp. (Billerica, MA) entered into a definitive agreement under which Merck KGaA will acquire all outstanding shares of common stock of Millipore for $107 per share in cash, or a total transaction value, including net debt, of approximately $7.2 billion. The transaction was approved by the boards of directors of both companies. Millipore and Merck will create a $2.9-billion partner for the life science sector, achieving scale in specialty...

Venture Funding for Healthcare Has Uncertain Future

 

The first quarter of 2010 saw a 12% increase in venture funding for start-up companies over the previous year, reports the Los Angeles Times, citing a Dow Jones VentureSource report. 
 
According to the Times, one year earlier, investments had “plunged to their lowest level since the late 1990s,” so the 12% increase is remarkable.
 
Healthcare pulled in $1.2 billion this first quarter, coming...
Growth and challenges for personalized medicine

 The U.S. personalized medicine market is estimated at about $232 billion, currently, and is projected to grow 11% annually, according to a recent PriceWaterhouseCoopers (PWC) report titled “The New Science of Personalized Medicine: Translating the Promise into Practice.” The personalized medicine market is expected to nearly double in size by 2015 to more than $450 billion, and the personalized medical care segment of the market—which includes IVD products—is...

Strong M&A activity expected for IVD industry

 In early January, the Wall Street Journal reported that merger and buyout activity is likely to heat up in the healthcare sector this year as the debate over a national health overhaul winds down. The newspaper added that stronger credit markets could bring more leveraged buyouts, which could bode well for more deals in medical technology. Analysts believe that M&A activity this year in the IVD industry should be robust.

“From our perspective, the M&A...
Inverness stays in acquisition mode

 Inverness Medical Innovations Inc. (Waltham, MA) entered into a distribution agreement with Epocal Inc. (Ottawa, Canada) to distribute its epoc Blood Analysis System for blood gas and electrolyte testing. The epoc (enterprise point-of-care) platform is a point-of-care analysis system that provides wireless bedside blood gas and electrolyte measurement testing solutions. Utilizing disposable smart cards, the epoc System produces laboratory quality test results in critical...

AdvaMed creates new IVD division

 Prompted in part by the healthcare reform efforts underway in Washington, AdvaMed has created a new division specifically for IVD companies: AdvaMed Dx. The division sees itself as an association within an association that maintains access to and support from AdvaMed.

Already attracting such high-profile members as Gen-Probe and bioMerieux, AdvaMed Dx is governed by an 18-member Board of Directors and an eight-member Executive Committee, both of which comprise IVD-company CEOs...