Medical Device Daily Washington Editor

The Centers for Medicare & Medicaid Services (CMS) reported earlier this week that it had chosen the first of two locations in southern California for a competitive bidding area for a demonstration project for clinical labs. The agency said it had selected the San Diego-Carlsbad-San Marcos, California, metro area to serve as a test bed for competitive bidding for lab services invoked under Medicare Part B services.

The project, mandated by the Medicare Modernization Act of 2003, will assess whether bidding can trim clinical lab costs without impairing diagnostic quality or turn-around time. CMS noted that it had paid roughly $6.7 billion to clinical labs in 2006.

Acting CMS administrator Kerry Weems said that the project builds “on the experience of CMS demonstrations for durable medical equipment, which found that competitive bidding can reduce spending, while assuring access and quality.”

The agency said it had conducted a pair of open-door forums in 2004 to get industry feedback on the proposal, followed by another forum to give labs a closer look at the bidding process. CMS has planned a conference for Oct. 31 in the bidding area to give eligible labs another opportunity to get up to speed on the details of the program. Labs that bill the agency for less than $100,000 a year will not be subject to competitive bidding, but will be reimbursed under the final bid amounts.

Vince Stine, the director of government affairs at the American Association for Clinical Chemistry (Washington), told Medical Device Daily “[w]e oppose competitive bidding because it will drive a lot of labs out of business due to the fact that the typical lab depends on Medicare for about 40% of its business.” AACC’s concerns are in part a reflection of the possibility that only larger labs will be able to maintain financial viability by offsetting the reduction in fees with volume.

Vandy researcher offers nanosponge

The nano world is producing lots of exotica, and the latest might sound like something from your kitchen sink, but the nanosponge is anything but an implement for cleaning up after dinner.

Eva Harth, PhD, an assistant professor of chemistry at Vanderbilt University Medical Center (Nashville, Tennessee), came up with the concept in her research on drug delivery, and thanks to a $478,000, five-year CAREER award from the National Science Foundation (Arlington, Virginia), she will have the resources to find out if the nanosponge will find a place in the world of nanosized drug delivery vehicles.

Harth opted for a different tack for nanoscale drug delivery by avoiding the capsule approach implicit in nanotubes and instead used a process known as cross-linking to fold molecules that are linear in shape into roughly spherical shapes of about 10 nanometers in diameter. Because the resulting molecule presents a myriad of pore-like openings, drug molecules can be inserted for transport.

“We can really load this up with a large number of drug molecules,” Harth said in an interview with physorg.com.

However, Harth’s work did not end with the development of the nanosponge as she has also developed a dendritic molecule that pulls the nanosponge across the cell membrane into specific areas within the cell. The dendritic molecule can pull large peptides and proteins — the building blocks of many biologics — into specific areas within the cell, but the dendrite can also slip past the blood-brain barrier, which offers a new approach to delivery of neurological therapies.

Harth and Heidi Hamm, PhD, a professor of pharmacology at Vanderbilt, who focuses on G proteins (a.k.a., guanine nucleotide binding proteins), are working on a dendrite configuration that will deliver peptides produced by G proteins in an attempt to correct intracellular signaling problems that are thought to lie at the bottom of diabetes and some tumors of the pituitary gland. Hamm described Harth’s dendrites as “very novel and versatile” molecules that “can be adapted to delivery of proteins, peptides, DNA and smaller chemical compounds like most drugs.”

Harth is also working with Dennis Hallahan, PhD, a professor of radiation oncology at Vanderbilt to find a delivery vehicle that will zero in on carcinomas in the lung with molecules of cisplatinum. While cisplatinum is a potent anticarcinogenic, it is toxic to any tissues it comes into contact with, making it the ideal candidate for targeted delivery.

“The people in my lab have tried at a number of different drug delivery systems and Eva’s works the best of those we’ve looked at,” Hallahan said.

Sensors may offer bedside cardiac marker assay

Researchers at the University of Ulster (UU; Coleraine, Ireland) have teamed up with their counterparts at the Indian Institute of Technology (Delhi, India) to develop whole-blood sensors that may detect biomarkers in low-volume blood samples in the diagnosis of heart disease. If the effort is successful, point-of-care testing could revamp cardiac care.

The teams propose to use carbon nanotubes to filter out blood cells that might adhere to sensors, which will then pick up a series of enzymes, such as troponin I, to help diagnose and gauge the severity of the condition. Such diagnoses will guide physicians in the use of defibrillators, for instance.

Jim McLaughlin, PhD, the director of the Nanotechnology and Advanced Materials Research Institute at UU, said that analysis of cardiac enzymes “will enable medical staff to determine the correct treatment. It will guide them on whether to administer clot-busting drugs, insert a stent or attempt defibrillation, for example.”