Personalized Medicine

July 19, 2012

The PMDxWorking Group endeavors to foster a positive public policy environment that maximizes...

April 26, 2012

John discusses the state of the industry and what he expects will be the top three issues...

January 19, 2012

Drugs approved with companion diagnostic tests represent the next wave of personalized...

November 29, 2011

BIOtech-NOW talks to Laurence Marton, Co-Chair of the Personalized Medicine World Conference...

July 23 2013
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the "Notification of Comment Period- 2013 Gapfill Payment Amounts Clinical Laboratory Fee Schedule (CLFS)" published by the Centers for Medicare and Medicaid Services (CMS) on May 9, 2013.
July 10 2013
Therapeutic biologics are an opportunity to address unmet patient needs, drive innovation, and assist China's transformation into a knowledge-intensive economy.
October 4 2012
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments on the New and Reconsidered Clinical Laboratory Fee Schedule (CLFS) Test Codes and Preliminary Payment Determinations published by the Centers for Medicare and Medicaid Services (CMS) on August 31, 2012. BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnologies, thereby expanding the boundaries of science to benefit society by providing better healthcare, enhanced agriculture, and a cleaner and safer environment. Specifically related to advanced personalized diagnostic products, a number of BIO companies develop and market in vitro diagnostic technologies for a variety of research, investigational, and clinical uses. BIO is deeply concerned with CMS’ payment proposal regarding Multi-Analyte Assays with Algorithmic Analyses (MAAAs), and is concerned generally with the lack of transparency in the process through the annual CLFS meeting and publication of the proposed payment methodologies. BIO believes these proposed payments will threaten access to molecular pathology tests by Medicare beneficiaries and have a devastating impact on the advancement of personalized medicine.
September 1 2011
The Biotechnology Industry Organization (BIO) appreciates the opportunity to submit comments regarding the Food and Drug Administration’s (“FDA’s”) draft guidance document entitled Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions (“the Draft Guidance”).
February 15 2012
The bill will modernize the FDA and accelerate patient access to cures and new treatments.
January 6 2011
BIO releases a report by Health Advances on the limitations of the nation’s reimbursement system for novel diagnostics and the impact of these limitations. 
January 3 2011
The 2011 BIO International Convention will highlight the latest trends and the newest opportunities for executives, investors, scientists, policy leaders, and media from around the world.
September 29 2010
BIO President and CEO Jim Greenwood released the following statement on action by the U.S. Circuit Court of Appeals last night to stay the lower court’s injunction on federally funded embryonic stem cell research...
May 4 2010
A new report issued by the Biotechnology Industry Organization underscores how biotechnology is benefiting society now more than ever, and is poised to help address some of the world’s most pressing challenges.