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CAP Today




December 2012

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Assay identifies patients at high risk despite small, node-neg lung tumors

A new prognostic assay from Life Technologies could help guide the postoperative management of T1a node-negative non-small-cell lung cancer, say the authors of a research letter published in the Oct. 24/31 issue of JAMA (2012;308:1629–1631).

The test, Pervenio Lung RS, measures the expression of 14 genes using quantitative PCR on RNA extracted from formalin-fixed paraffin-embedded specimens. It assigns patients to low-, intermediate-, and high-risk groups based on clinically validated cutoff values for a calculated risk score (Kratz JR, et al. Lancet. 2012;379(9818):823–832).

A total of 1,439 patients who had undergone resection of nonsquamous NSCLC in the Kaiser Permanente Northern California system between 1998 and 2005 or at one of three institutions from the China Clinical Trials Consortium between 2000 and 2008 were enrolled in two original validation studies. The 269 patients with node-negative tumors of less than 2 cm were included in the latest study reported in JAMA in October.

Ninety-two (34.2 percent) were identified as high risk by the assay, and survival was significantly different among the risk groups categorized as high (52. 3 percent), intermediate (69.1 percent), and low (83.0 percent). Differences in survival were also found among those with the 26 tumors that were 1 cm or smaller: Survival was 100 percent in the low-risk group, 76.2 percent in the intermediate-risk group, and 33.3 percent in the high-risk group.

The authors of the study are Johannes R. Kratz, MD, previously of the University of California, San Francisco, and now of Massachusetts General Hospital; David M. Jablons, MD, and Michael J. Mann, MD, of UCSF; Stephen K. Van Den Eeden, PhD, of the Department of Research, Northern California Kaiser Permanente, Oakland; and Jianxing He, MD, PhD, of First Affiliated Hospital of Guangzhou (China) Medical College.

“It is an important prognostic assay for stage I and II nonsquamous cell NSCLC,” Dr. Jablons, UCSF professor and chief of thoracic surgery, told CAP TODAY. The JAMA study looked specifically at patients with T1a node-negative tumors, the type that can be found in low-dose computed tomography screening, he says. “But the larger study in The Lancet confirmed the prognostic benefit of the assay for all stage I—Ia and Ib—as well as across higher stage II and even stage IIIa patients,” says Dr. Jablons, who was involved in the test’s development.

Dr. Mann, co-developer of the test and associate professor of cardiothoracic surgery at UCSF, said how to maximize the chances of survival for the patients who would be diagnosed at the earliest stages is one of the challenges of CT screening. “The Pervenio test could add a layer of sophistication and personalization to the care of that growing population” that could improve survival rates, he said in a statement.

The study was funded by private endowments to the UCSF thoracic oncology laboratory and by Pinpoint Genomics, developer of the assay and which Life Technologies acquired six months ago. Life Tech makes Pervenio Lung RS available through its clinical services lab.

Supreme Court to hear gene patent case

The Supreme Court agreed on Nov. 30 to hear a case, Association for Molecular Pathology v. Myriad Genetics, in which it will decide whether isolated human genes are patentable. The CAP is a named plaintiff in the case.

The decision of the Court will determine whether and to what extent isolated genes are patentable under current law. “It is quite possible that, after the Court rules, Congress will revise the Patent Act to strike a balance among the competing interests that bear on this question,” Jack Bierig, of the Chicago law firm Sidley Austin, told CAP TODAY. “Those interests,” he added, “include encouraging research and innovation relating to the human genome, not making genetic testing unaffordable for patients, and ensuring that research in this area is not thwarted by the need to obtain numerous licenses.”

The Court will decide the case by June 30, 2013.

UPMC to invest $100 million in data warehouse and analytics

The University of Pittsburgh Medical Center will invest $100 million over five years to create a data warehouse of clinical, financial, administrative, genomic, and other information that will advance personalized medicine.

Oracle, IBM, Informatica, and dbMotion will be UPMC’s partners in integrating and analyzing the data. Advanced analytic and predictive modeling applications for clinical and financial decisionmaking are expected to lead to better patient outcomes, strengthen research capabilities, produce quality improvements across UPMC, and lower costs.

With the help of the Carnegie Mellon Software Engineering Institute, UPMC has studied best practices in analytics inside and outside of health care. “We’re now ready to turn what we’ve learned into action to support our goal of developing new models of affordable, effective, patient-focused health care,” Lisa Khorey, UPMC’s VP of enterprise systems and data management, said in a statement.

The university and its IT partners over the next two years will install the hardware and software necessary to create a comprehensive data warehouse that will pool data from more than 200 information sources across UPMC, UPMC Health Plan, and outside entities, including labs and pharmacies. Clinicians, researchers, and administrators will have secure, real-time access to data and analytic tools that fit their interests and needs.

Policy and preventable infection

The 2008 policy to reduce payments for central catheter-associated bloodstream infections and catheter-associated urinary tract infections had no measurable effect on infection rates in hospitals, say the authors of a study published Oct. 11 in the New England Journal of Medicine (Lee GM, et al. 2012;367:1428–1437).

The Centers for Medicare and Medicaid Services in fall 2008 discontinued additional payments for select hospital-acquired conditions that were considered preventable. “Given the recent decision to expand the policy of nonpayment for preventable complications to Medicaid through the Affordable Care Act, an understanding of the effect of this program on patient care is critically important,” the authors write.

They say there were strong downward secular trends for targeted health care-associated infections long before the CMS announced and implemented its policy, but “no measurable additional benefit of the policy.”

The authors provide three possible explanations: 1) the CMS measure uses ICD-9 codes that billing staff assign, and many hospitals may have responded by changing their billing practices; 2) with much attention already paid to preventing health care-associated infections, the incremental effect of adjusting payment may have been limited; and 3) the financial incentives were small.

The effect on patient outcomes of financial programs that reward rather than penalize providers, known as pay for performance, has been mixed, they note, with a few studies showing modest gains and most finding little effect or no effect at all.

FDA clears Nanosphere’s CYP2C19 test

Nanosphere has received FDA 510(k) clearance for its CYP2C19 nucleic acid test on the automated Verigene system. The test, which is indicated as an aid for clinicians in determining therapeutic strategy for drugs metabolized by the CYP450 2C19 genetic pathway, identifies the CYP2C19 *2, *3, and *17 variations, if present, directly from a patient’s whole blood sample in less than 2.5 hours.

The *2 and *3 variants account for the majority of reduced drug metabolism; the *17 variant is associated with increased drug metabolism.

The Verigene system performs tests for genetic, infectious disease, and protein targets on a single platform.


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