A Medical Device Daily

Luminex (Austin, Texas), a multiplex solution developer, reported that it has acquired a nonexclusive license from The Johns Hopkins University (Baltimore, Maryland) for the rights to use the university's patented cystic fibrosis genetic markers in the company's molecular diagnostic products sold in the U.S. Rights to use the genetic markers will be included with Tag-It cystic fibrosis products, which are available from Luminex's new division, Luminex Molecular Diagnostics, and extend to the company's distributors and end-user customers. Financial terms were not disclosed.

"These genetic markers from Johns Hopkins are an important element in advancing the diagnosis and monitoring of cystic fibrosis," said Jeremy Bridge-Cook, VP of Luminex. "We are pleased to be able to provide our customers and distributors with the rights to these markers as part of our Tag-It Cystic Fibrosis Kit."

Cystic fibrosis (CF) is the most common autosomal recessive disorder in the Caucasian population, according to Luminex. It is a chronic disease that affects the lungs and digestive system and can be found in more than 30,000 children and adults in the U.S. and 70,000 children and adults worldwide, the company said.

The Tag-It Cystic Fibrosis Kit is designed to aid in newborn screening and confirmatory CF diagnostic testing in newborns and children and can determine CF carrier status in adults. The kit simultaneously screens for the 23 cystic fibrosis transmembrane conductance regulator (CFTR) gene mutations and four variants (polymorphisms), as recommended by the American College of Medical Genetics (ACMG; Bethesda, Maryland) and the American College of Obstetricians and Gynecologists (ACOG; Washington) in 2004. It also screens for 16 additional CFTR mutations prevalent in North America or the world.

The license provides Tag-It CF Kit users and distributors rights to four mutations (549N, 551D, 553X, 559T) tested for in the kit and covers two mutations (553X and 551D) in the screening panel of 23 cystic fibrosis gene mutations recommended by ACMG and ACOG, the company said.

Luminex says that performance testing has shown that the Tag-It CF Kit operates with 100% accuracy and greater than 99.9% reproducibility and precision. The kit is the first multiplexed human disease genotyping test to be cleared by the FDA as an in vitro device for diagnostic use in the U.S., the company said. It has also received CE mark certification and Health Canada clearance, allowing the test to be marketed for diagnostic purposes in the European Union and Canada.

Luminex was created last month with Luminex's acquisition of Tm Bioscience (Toronto). The division specializes in DNA-based research and diagnostics and is focused on the development of nucleic-acid based testing products for genetic testing, personalized medicine and infectious disease.

Briefly Noted

DexCom closer to device reimbursement

DexCom (San Diego) said it is one step closer to gaining reimbursement for its continuous glucose monitoring devices. The company said the Centers for Medicare and Medicaid issued a positive preliminary decision for DexCom to develop Healthcare Common Procedure Coding System codes for its devices. The codes describe specific healthcare items and procedures and are necessary for processing health insurance claims.

The company expects a final decision to be published in late October or early November. If the code is issued then, DexCom expects the HCPCS codes to go into effect Jan. 1, 2008. DexCom is a company focused on pioneering technologies for the continuous monitoring of glucose in people with diabetes.

ICD-9-CM code validates SPY system

Novadaq Technologies (Toronto), a developer of real-time medical imaging systems and image-guided therapies for the operating room, reported that the Centers for Medicare and Medicaid Services (CMS) Fiscal 2008 Rules include a new ICD-9-CM procedure code for Intra-operative Fluorescence Vascular Angiography, which can be performed using SPY Imaging Systems.

The new ICD-9-CM procedure code, effective October 1, will be used by hospitals to bill for costs associated with SPY Intra-operative Imaging procedures performed by cardiac surgeons in the operating room.

"This code is tremendously important in supporting our ability to measure the impact of intra-operative imaging on the quality of care for coronary artery bypass patients at the health policy level," said T. Bruce Ferguson, MD, professor and associate chief of the Division of CT and Vascular Surgery, Division of Clinical Effectiveness, Department of Surgery, Brody School of Medicine at East Carolina University (Greenville, North Carolina) .

ECRI now ECRI Institute

ECRI (Plymouth Meeting, Pennsylvania), an independent healthcare research organization, reported changing its name to ECRI Institute, and it unveiled a new logo with the tagline "The Discipline of Science. The Integrity of Independence."

"ECRI Institute is an organization of seekers striving to find broad-scale, systematic approaches that guide healthcare organizations in making the best possible patient care decisions," said Dr. Jeffrey Lerner, president/CEO of ECRI Institute. "Our refreshed brand builds on our legacy of independent, unbiased, rigorous research and more accurately reflects the wide-ranging value we bring to healthcare."

ECRI Institute says it serves more than 5,000 hospitals, health systems, government agencies, public and private payers, and allied healthcare organizations.

Radianse moves to larger facility

Radianse(Andover, Massachusetts), a provider of solutions that improve patient flow and resource management, reported two initiatives.

The company has completed relocation of its headquarters from Lawrence to larger facilities in Andover, Massachusetts.

"Our new space has allowed us to increase our engineering and manufacturing capabilities to meet overwhelming demand for our latest offering: Prospective Patient Flow Manager, which uses radio frequency identification (RFID) technology to give clinicians a real-time overview of the care continuum. Hospitals can identify and reduce patient flow bottlenecks and do more with fewer resources, boosting staff and patient safety and satisfaction while increasing revenue — a compelling value proposition," said Radianse CEO Mark Sakaniwa.

Proposals sought for AdvaMed 2007

AdvaMed (Washington) has issued a call for proposals and suggestions for program content for AdvaMed 2007, Oct. 1-3 at the Ronald Reagan Building and International Trade Center in Washington.

"AdvaMed 2007 is unique in that it is the only event specifically tailored by industry, for industry," said Stephen Ubl, president/CEO of AdvaMed. "By asking our members to submit proposals and suggestions for content, we are ensuring a program aligned with the important questions our industry is asking. That's something no other medical technology conference can say."

AdvaMed 2007 will offer educational workshops, breakout sessions and keynote addresses on issues such as Medicare reimbursement, intellectual property, compliance, international market access, business development, corporate finance, public policy, emerging company issues, 21st century medicine and the value of medical technology.

AdvaMed 2007 welcomes applications, submissions and suggestions for program content for panels (90 minutes), workshops (120 minutes or longer) and individual expert speakers.

BioDtech to relocate to Birmingham

BioDtech (Nashville, Tennessee), an emerging life science company, reported that it will relocate its corporate headquarters from Nashville, Tennessee to Birmingham, Alabama. The company plans to expand its existing R&D efforts in the new Innovation Depot facility located in the entrepreneurial district in downtown Birmingham near the University of Alabama Birmingham.

"We are making this move to take advantage of an area that combines a strong intellectual talent pool with a world class research facility so that we can continue to execute our plan to profitability, while building our company for the future," said Michael Pepe, president/CEO of BDTI.

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