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 t
(July, 2010)
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
(July, 2010)
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 hos
(July, 2010)
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 hos
(July, 2010)
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 prov
(July, 2010)
AACC's Industry Division
AACC’s Industry Division addresses the specific needs of its members while working harmoniously with AACC as a whole.
(July, 2010)
The Problem of Regulatory Uncertainty
IVD manufacturers are accustomed to risk. Taking risks is part of their business. Companies develop plans to identify and mitigate risks, from product development to finished product manufacturing. While risks cannot be eliminated, generally they can be recognized and managed.
One category of risks
(July, 2010)
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 conduct
(July, 2010)
Court rules gene patents invalid
The Federal District Court for the Southern District of New York ruled that certain claims covering isolated DNA sequences in seven patents on the BRCA genes owned or exclusively licensed to Myriad Genetics Inc. (Salt Lake City) are invalid. The ruling follows a lawsuit that was brought by a group o
(July, 2010)
Developing a point-of-care mass spectrometer
Recent developments suggest that bringing mass spectrometry to the point of care is feasible and that mass spectrometers will play an important role in personalized medicine.
(July, 2010)
So Much To Do, So Much To See
More than just Disneyland, Anaheim, California is unlike any other travel destination in the world, and it ranks as one of the most visited places in the United States.
(June, 2010)
Getting to Anaheim
Four major airports service the Orange County area with more than 2,500 flights daily from across the globe.
(June, 2010)
International Market Briefing
This annual meeting discusses the latest developments in world IVD markets and highlights global opportunities for IVD manufacturers.
(June, 2010)
Clinical Lab Expo Preview
Exhibitors in the OEM Pavilion will include OEM supplier companies offering components for IVD products and systems.
(June, 2010)
Conference Preview
AACC has organized many different types of exciting conference sessions during the annual meeting.
(June, 2010)
Introduction to the AACC Annual Meeting
Welcome to the 2010 AACC Annual Meeting and Clinical Lab Expo. This year's tradeshow is expected to have more than 700 exhibitors and 1,900 booths.
(June, 2010)
AACC’s Industry Division
AACC’s Industry Division addresses the specific needs of its members while working harmoniously with AACC as a whole.
(June, 2010)
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
(May, 2010)
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.
(May, 2010)
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 a
(May, 2010)
