Carolina Liquid Chemistries, GlycoMark Partner for New Diabetes Management Test

Carolina Liquid Chemistries Corp will market the GlycoMark® blood test as one of a complete range of diabetes assays for the BioLis 24i benchtop chemistry analyzer. Carolina Liquid Chemistries teamed up with GlycoMark Inc, the test manufacturer, to market a complete system for diabetes-associated diagnostic tests.

“There are 1.6 million people diagnosed with diabetes each year,” said Phil Shugart, president of Carolina Liquid Chemistries. “Through this partnership, we will promote a system for helping physicians manage this epidemic. The Biolis 24i is the only physician office instrument that offers a complete menu of the diabetic assays: HbA1c, glucose, fructosamine, insulin, kidney function tests, and now GlycoMark, one of the most important tests for better management of diabetes and prevention of the devastating diseases that accompany it.”

Monitoring and controlling postprandial hyperglycemia—the high blood glucose spikes a person experiences soon after eating—are key aspects of proper diabetes management. GlycoMark is an FDA-approved, reimbursed, nonfasting blood test that monitors intermediate glycemic control and can be administered monthly. “Because HbA1c only identifies a person’s average glucose level over time, it misses up to 40 percent of patients in near normal ranges (6.0% to 8.5%) who are not in good glycemic control,” said Eric Button, president of GlycoMark Inc. “This can lead to cardiovascular disease, retinopathy, and other complications of diabetes. GlycoMark identifies peak glucose levels after a person eats, so physicians can identify those patients and prescribe the proper medications.”

Until now, GlycoMark was available only through reference labs, so physicians had to wait for results before prescribing treatment. Now, with the BioLis 24i, the physician’s office can perform the test on site and have the results within minutes. “The physician has same-day results, can provide immediate feedback to the patient, and make treatment decisions and medication adjustments before the patient leaves the office,” Shugart said.

Source: Carolina Liquid Chemistries

Longhorn Vaccines & Diagnostics Receives EUA for H1N1 Assay

Longhorn Vaccines & Diagnostics announced it has been granted Emergency Use Authorization (EUA) from the FDA for its Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay™ in CLIA high-complexity laboratories.

The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay is a ready-use assay that requires no mixing prior to use and has been authorized for use on the ABI 7500. The device includes PrimeStore MTM, a clinical collection and transport solution that preserves the released nucleic acids, including labile RNA for testing, and contains an internal positive control, providing the first specimen-collection solution to contain an internal RNA control capable of tracking the degradation of the sample from the point of collection.

“Sample integrity, and the ease and economy of transporting collected samples, are key components to testing during outbreaks,” said Gerald Fischer, MD, Longhorn Vaccines & Diagnostics’ CEO. “An infectious disease physician and a molecular biologist designed The Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay to generate rapid, high-quality PCR results in as little as 2 hours while improving safety and reducing laboratory preparation time.” Longhorn Vaccines and Diagnostics will continue to develop the Longhorn Influenza A/H1N1-09 Prime RRT-PCR Assay and expects to submit a separate 510(k) in 2010.

Source: Longhorn Vaccines and Diagnostics

Diagnostic Hybrids Receives EUA for D3 Ultra 2009 H1N1 Influenza A Virus ID Kit

Diagnostic Hybrids, a Quidel Company, has received emergency use authorization from the FDA for its D3® Ultra™ 2009 H1N1 Influenza A Virus ID Kit, a monoclonal antibody fluorescent staining kit for the specific identification of 2009 H1N1 influenza A in direct patient specimens or incubated tissue cultures.

The D3 Ultra 2009 H1N1 Influenza A Virus ID Kit is to be used for individuals with signs and symptoms of influenza and who previously tested positive for the presence of influenza A virus-infected cells by a currently available FDA-cleared direct immunofluorescence influenza A antibody device such as the D3 Ultra Respiratory Virus Screening and ID Kit. Emergency use authorization allows for the early availability of important diagnostic and therapeutic tools “to diagnose, treat, or prevent serious or life-threatening diseases or conditions […] when there are no adequate, approved and available alternatives.”

“The FDA’s emergency use authorization of Diagnostic Hybrids’ H1N1 Influenza A Virus ID kit will allow access to a monoclonal antibody product with great potential for expediting patient care in a time when fast, accurate diagnosis of 2009 H1N1 infection is critical,” said David R. Scholl, PhD, senior vice president, commercial operations and president of Diagnostic Hybrids. “As we enter the main part of flu season in North America, we are proud to provide large and small laboratories alike with a cost-effective method for the detection of 2009 H1N1 infections.”

The D3 Ultra H1N1 ID Kit is the first indirect fluorescent assay available on the market that specifically identifies the 2009 H1N1 influenza A virus from nasopharyngeal swabs, aspirates, and washes. It complements the company’s other respiratory testing technologies, which can detect the H1N1 virus as influenza A positive, but do not specifically identify the 2009 H1N1 influenza virus subtype.

Source: Quidel

CLSI Hires New VP, Marketing and Business Development

CLSI recently hired Barbara Goldsmith, PhD, FACB as vice president, marketing and business development. In her new role, Dr Goldsmith will oversee the development and implementation of new business development and marketing strategies and programs that build CLSI’s visibility and leadership, and support the organization’s mission, strategic plan priorities, and brand value. “It is an honor to work with the talented professionals at CLSI. It is my hope to contribute to its stellar reputation and promote the high-quality standards and guidelines produced by CLSI and its many volunteers,” said Dr Goldsmith.

“Barbara has excellent experience in all areas of the clinical laboratory and association management. She has the unique perspective of having experience and insights into CLSI’s three constituencies of government, industry, and professions. With her years of clinical laboratory experience, relationship-building, teaching, and leadership ability, Barbara brings exciting new ideas, energy, and enthusiasm to this new role here at CLSI,” said Glen Fine, MS, MBA, CAE, CLSI executive vice president.

Dr Goldsmith comes to CLSI with the unique perspective of having worked in laboratory services for nearly 30 years. Before coming to CLSI, she was vice president of laboratory services at Caritas Christi Health Care in Boston, and before that as the executive director of the Health Alliance Laboratories in Cincinnati. She has also been the director of laboratory services and director for clinical chemistry at St. Christopher’s Hospital for Children in Philadelphia.

Source: Clinical Laboratory Standards Institute