FDA grants CLIA waiver for QuickVue

Quidel (San Diego), a provider of point-of-care (POC) diagnostic tests, said that the FDA granted CLIA waiver for the QuickVue RSV test for the qualitative detection of respiratory syncytial virus (RSV). The waiver makes the QuickVue RSV test more widely available for use, especially in physician offices and clinics where waived tests are used most frequently.

The RSV test is intended for use as an aid in the diagnosis of acute RSV viral infections for symptomatic pediatric patients.

“We are pleased the QuickVue RSV test will now be more widely available for use by physicians, helping to aid clinical diagnosis and guide patient management decisions for some of the most fragile patients of all, infants and young children. With QuickVue tests for some of the most common respiratory ailments including influenza, Strep A, and RSV, Quidel is committed to providing physicians and caregivers with a family of rapid diagnostic tests that have a demonstrated clinical value, a prime example of how our Quidel Value Build strategy continues to help build our customer base,” said Caren Mason, president/CEO of Quidel.

DataTrak receives clinical trial sponsors

DataTrak International (Cleveland), a technology and services company focused on eClinical solutions for the clinical trials industry, said that it has received a block of six cardiac safety studies from six clinical trial sponsors, as a result of its ongoing relationship with COResearch, a business unit of Duke Medical Strategies. The value of these new trials to DataTrak is expected to be about $800,000.

Encore Medical changes name to DJO surgical

DJO (San Diego) said that in conjunction with the merger with ReAble Therapeutics (Austin, Texas) in late 2007, the name of its Encore Medical business unit has been changed to DJO surgical. Encore Medical is a supplier of reconstructive total joint implants for the hip, knee and shoulder.

“Our mission at DJO is to improve the quality of life of the people who use our products, whether they are trying to prevent injuries or rehabilitate from surgery, injury or degenerative disease,” said Les Cross, CEO.”

DJO makes devices that provide solutions for musculoskeletal health, vascular health and pain management.

LHC adopts stockholder plan

LHC Group (Lafayette, Louisiana) said that it has adopted a stockholder protection rights plan designed to strengthen the ability of its board to protect stockholders’ rights.

The rights plan is designed to protect LHC Group stockholders against abusive or coercive takeover tactics and takeover tactics not in the best interest of LHC and its stockholders, such as acquisitions of control without paying all stockholders a fair premium, coercive tender offers and inadequate offers. The rights plan is not intended to prevent an offer that the board concludes is in the best interests of LHC and its stockholders.

LHC provides post-acute healthcare services primarily in non-urban markets.

NIH women’s health study now on web

The 2008 National Institutes of Health (NIH) Research Priorities for Women’s Health is a web resource used to identify overarching themes, specific health topics, and research initiatives in women’s health. Within each section of the Web site are topics with links to relevant and authoritative resources and research initiatives for women’s health. NLM has created specific user friendly strategies for these topics to ease searching ClinicalTrials.gov and PubMed.

Women’s Health Resources from the NLM Web site can be found at: http://sis.nlm.nih.gov/outreach/womenshealthoverview.html.

Women’s Health Resources from the ORWH Web site can be found at: http://orwh.od.nih.gov/nat_lib_med.html.

The National Library of Medicine is the world’s largest library of the health sciences. For more information, visit the Web site at http://www.nlm.nih.gov/.

The Office of the Director, the central office at NIH, is responsible for setting policy for NIH, which includes 27 Institutes and Centers. Additional information is available at http://www.nih.gov/icd/od/index.htm.

For more information about NIH’s Office of Research on Women’s Health, visit http://orwh.od.nih.gov/

Gene Express joins PMC

Gene Express (Toledo, Ohio) said that it has become a member of The Personalized Medicine Coalition (PMC). PMC membership encompasses a broad spectrum of academic, industrial, patient and healthcare provider constituencies.

Membership is open, but not limited, to universities and academic medical centers, non-profit research entities, relevant trade associations, patient advocacy groups, government officials (ex-officio), healthcare organizations, healthcare providers, payers, information technology companies and research-based commercial companies that offer an array of products and services including research tools, diagnostic technologies and products, screening services and therapeutic interventions.

To learn more about PMC, go to http://www.personalizedmedicinecoalition.org/

Gene Express assists drug and molecular diagnostic development by providing standardized genomic data.