Medical Device Daily Washington Editor

A recent report by market analyst Life Science Intelligence (Huntington Beach, California) projects a healthy market for artificial discs in the next five years, but the market may flatten out after that date, assuming technological developments keep apace and reimbursement issues clear up.

According to the report, the market for total spinal disc replacement may increase by a factor of eight between last year and 2013, from $55 million a year to $440 million. Replacement discs are under increasing scrutiny by FDA as a recent device/application-specific guidance makes clear (Medical Device Daily, April 21). All the same, growing physician interest and a lack of alternatives for those with serious damage to the disc will fuel the rise in this market's fortunes.

The Centers for Medicare & Medicaid Services (CMS) has given little ground on some disc therapies and devices, and recently proposed no change to its coverage of thermal intradiscal procedures (MDD, July 21) for no coverage. The agency also declined to cover lumbar artificial discs last year after determining that the underlying data did not present an argument that the procedure was reasonable and necessary (MDD, Aug. 17, 2007), but allowed local carriers to reimburse for the procedure.

Despite the optimism in the LSI report, the report also states that the market for disc nucleus replacement will start shoving artificial discs aside after 2013, "after the introduction of biological repair products, which could occur as early as 2012." This development should "contribute to slower growth in the market for artificial discs after 2013."

Pat Anderson, spokesman for orthopedic specialist Stryker (Kalamazoo, Michigan) told Medical Device Daily that while the numbers do not strike the company as unrealistic, "there are a number of things that have to come into play to make that growth take place," including reimbursement and long-term efficacy data. As long as those factors come online and anterior approaches to the spine are developed, "we see all the products seeming to move through at a reasonable rate."

Privacy issues flare up at NIH

Privacy advocates found yet more fuel for concern with the recent revelation that genetic information posted at the agency's web site might not be as free of identifying information as was believed. According to the Los Angeles Times, the National Institutes of Health pulled a pair of patient DNA databases from its web site with no public announcement.

According to the Times article, which appeared Aug. 29, the databases contained genetic information for more than 60,000 and were posted earlier this year. However, a member of the NIH staff said the DNA would only be of use if the patient's genetic data already were in the hands of a would-be privacy invader.

Privacy was among the stipulations for patients who consented to inclusion of their genetic data in the database. NIH assembled and posted the data in January and since that time, 140 entities have downloaded at least some portion of the data. There is said to be no way to withdraw or prevent further distribution of the data.

Elizabeth Nable, MD, the head of NIH's genetic oversight body, was quoted in the Times article as saying that while it is possible "that a patient's privacy could have been violated," the agency opted to "err on the side of caution" in the matter. She also said that anyone with ill intent would have to be in possession of that individual's genetic profile and possess a complex algorithm to confirm whether a given patient's DNA is in one of the databases.

All the same, reaction was swift. Fred Bieber, MD, a geneticist at Harvard Medical School (Boston), told the newspaper that the take-home message is "that with enough genetic information, it's becoming easier to identify individuals even though their identities are presumed to be" hidden.

Russ Altman, PhD, editor of the journal Bioinformatics and chair of the bioengineering department at Stanford University (Stanford, California), described the incident as "a big deal," remarking that NIH had "worked very hard on [the new privacy protocol] and something has come up that has thrown it into doubt."

ABMC gets CLIA waiver for drug test

American Bio Medica (ABM; Kinderhook, New York) said recently that it has obtained a waiver from FDA under the Clinical Laboratory Improvements Act for the company's Rapid TOX line of point-of-collection drug tests. The product line includes tests for 14 drugs, including opiates and cocaine, and gives the firm access to hospitals and clinics rather than just labs.

The company's CEO, Stan Cipkowski, said in an Aug. 27 statement that ABM has been "waiting some time for this decision" and that the decision "allows us to complete our negotiations with several distributors who service the physician and hospital market." Cipkowski said he expects "to see an immediate impact on sales beginning in the fourth quarter of this year and ramping up throughout 2009."

ABM specializes in the drug testing space, offering the Rapid line of screens, which includes the Rapid Reader, a unit that draws data from one of the firm's analyzers and reports the data to PCs via a USB port.

Cipkowski told MDD, "our lab partner has more than 1,500 patient centers and [they] were unable to use our devices, and now they can." He said he could not identify this entity, but said the business with that company "was our primary reason" for pursuing the waiver. He said ABM expects to move $2.5 million to $3 million in products to that company.