A Medical Device Daily

Makers of diagnostics may want to take note of a new round of funding for a program at the National Institutes of Health (NIH) that promises to boost scientific understanding of a relatively novel set of biomarkers for cancer. According to a recent announcement at the NIH web site, the National Cancer Institute (NCI), one of the NIH’s centers, has come up with about $15 million to fund a five-year effort “to discover, develop, and clinically validate cancer biomarkers by targeting the carbohydrate (glycan) part of a molecule.”

This branch of medical science, dubbed glycobiology, is apparently not utterly new. It is the subject of a scientific society, the Society for Glycobiology (St. Louis) as well as a journal titled Glycobiology that has been in production since before 1990.

According to the Aug. 21 press release, carbohydrate structures attached to protein and lipid molecules can serve as an index of carcinogenicity for several forms of cancer, including cancers of the prostate, breasts, lungs, colon and pancreas.

NCI director John Niederhuber, MD, said in a prepared statement that medical science has long known about glycobiology, but that “[w]hile this area has compelling scientific interest, its biological and chemical complexities have often discouraged investigation.” However, investment in medical technology has improved the understanding of protein and carbohydrate chemistry, and as a result, “research into this intriguing area has experienced renewed interest,” he said.

The NIH press release also said that numerous studies that compared “normal and tumor cells have shown that changes in the glycan structures of cells correlate with cancer development.” The release said that glycans are “extremely abundant,” but that a systematic study of their correlation with cancer cells is only just now practical.

“Many protein biomarkers also have glycan components, and analysis of these two molecular structures together may improve the value of tests such as those for prostate-specific antigen (PSA), CA-125, and carcinoembryonic antigen, which are sometimes used in prostate, ovarian, and colon cancer detection, respectively,” the NIH statement noted.

Sudhir Srivastava, PhD, chief of the Biomarkers Research Group in the cancer prevention division at NCI said that examination of biomarkers and ways to identify them are “critically important to both the basic understanding of cancer and the ability to identify early cancer and risk for cancer.” In reference to a new alliance of glycobiologists from across the NIH’s various offices, Srivastava said the improved focus on glycans “will accelerate the pace of biomarker development and discovery.”

Srivastava was referring to what the press release described as “the new trans-NIH Alliance of Glycobiologists for Detection of Cancer and Cancer Risk.” According to NIH, this group consists of scientist from the NCI Tumor Glycome Laboratories, the Consortium for Functional Glycomics, and the NCI Early Detection Research Network.

Among the academic centers participating in this branch of research is the University of Georgia (UGA; Athens). J. Michael Pierce, PhD, and others at UGA are working to identify glycoprotein and glycolipid biomarkers for pancreatic cancer that are known to show up in pancreatic ductal fluid. Pierce and his team hope to establish whether these biomarkers can be detected in blood samples.

Another of the NIH-funded projects is headed by Margaret Huflejt, PhD, of Cellexicon (La Jolla, California). Huflejt and others at Cellexicon are examining how far in advance several cancers can be predicted by looking at the signatures left by anti-glycan auto-antibodies.

CMS pilot to look at post-acute care costs

The Centers for Medicare & Medicaid Services (CMS) reported earlier this week that it will start recruiting providers for a pilot project designed to give the agency data about post-acute care and how various providers stack up in economically delivering that care.

The Post-Acute Care Payment Reform Demonstration will pull data from participating long-term care hospitals, inpatient rehabilitation facilities, skilled nursing facilities and home health agencies. CMS said that it wants to “generate recommendations for improving CMS payment models” by “aligning incentives among the four” types of caregiver institutions. It also hopes to generate meaningful data on discharge patterns and outcome comparisons across the four types of settings.

CMS indicated it has been working for a year to “develop a uniform patient assessment tool for use at discharge” known as CARE (Continuity Assessment Record and Evaluation). It is recruiting providers, but interested parties can contact CMS. The agency said that it does not anticipate any waiver of payment rules in connection with the pilot.

The study, which was mandated by the 2005 edition of the Deficit Reduction Act, will recruit from institutions in 10 metropolitan statistical areas as well as a variety of provider organizations. Among the characteristics of provider companies the agency will look at are patterns of corporate ownership, whether the organization operates on a for-profit basis, and the availability of other providers in that organization’s network that can also be recruited to the pilot. CMS will select providers “in the fall of 2007” and noted that interested parties should e-mail the agency at pat-comments@rti.org.