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Put It on the Board, 12/14

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Crizotinib shrinks tumors in ROS1-positive NSCLC

Forecast sees 6% IVD market growth

Payers set higher bar for pricey new technology

USPSTF: Scant support for routine vitamin D testing

Imaging IDs receptors for cancer treatment

ARUP sponsors PLUGS

Roche acquires Ariosa

CE mark for Ortho’s Vision

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Crizotinib shrinks tumors in ROS1-positive NSCLC

A recently published New England Journal of Medicine study that shows promise for the treatment of ROS1-positive lung cancer patients also demonstrates the value of advanced diagnostics, says John Iafrate, MD, PhD, the article’s senior author.

Thirty-six of 50 study participants whose non-small cell lung cancer was driven by a rearrangement of the ROS1 gene saw their tumors shrink significantly when they received treatment with the drug crizotinib (Xalkori). The drug suppressed tumor growth in another nine ROS1-positive patients in the study, a phase one trial.

The patients got twice-daily doses of crizotinib. Tumor size was reduced in 72 percent of patients and tumor growth was halted in another 18 percent. The average duration of response was more than 17 months. At the end of the study, half of the 50 patients were still receiving crizotinib with no evidence of tumor progression. The study was funded by Xalkori’s manufacturer, Pfizer (Shaw AT, et al. N Engl J Med. 2014;371:1963–1971).

Dr. Iafrate says that discovering the apparent effectiveness of crizotinib would not have been possible without first having a program to regularly perform genetic testing of NSCLC patients. He is medical director of the Center for Integrated Diagnostics at Massachusetts General Hospital.

“It was that routine testing of every [NSCLC] patient at MGH, and a small number of other sites, over a number of years that allowed us to get patients in this trial to produce the evidence needed to prove that crizotinib is effective,” he tells CAP TODAY.

For clinicians, the message from the study is straightforward, says Dr. Iafrate, associate professor of pathology at Harvard Medical School.

“Although this is not a randomized controlled study, the study shows the benefit ROS1-positive patients receive with single-agent crizotinib therapy,” he says. “In general, crizotinib has fewer side effects than chemotherapy, and we now know from ALK studies that such patients may have a better quality of life and possibly longer survival—although we need a controlled trial to show that.”

The study also sends an imperative to pathologists, Dr. Iafrate says.

“As pathologists, we have to assist our oncology colleagues to find these patients. Because of increasing demands, including an ever increasing number of genes in lung cancer, we’ll almost certainly need to do panel testing, such as next-generation sequencing, to capture as many alterations as possible. It gets very expensive to do these one at a time. We often run out of material, especially with patients who have small biopsies and advanced tumors. Pathologists have to lead the field in identifying these patients and developing the technology that will make it cost-effective.”

During the study period, FISH testing was done to identify patients with the ROS1 rearrangement. Now for each lung cancer patient at MGH, two separate next-gen sequencing panels are run, one focused on point mutations and indels, the other on gene fusions. Dr. Iafrate and his colleagues have developed, and are using, a platform-agnostic next-gen method they call anchored multiplex PCR (Zheng Z, et al. Nat Med. 2014;20:1479–1484).

Dr. Iafrate acknowledges that investing in next-generation sequencing when reimbursement is meager or nonexistent is a huge challenge, but he insists it is one that must be surmounted to amass the required evidence base.

“It’s incredibly important to find these genetic alterations. However, it will take a long time to get the phase three clinical trial data that everyone holds up as the gold standard for clinical utility,” he says. “We have to find a way in the interim to make this testing sustainable. Payers and regulators are demanding the highest level of clinical utility to get reimbursed.” —Kevin B. O’Reilly

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Forecast sees 6% IVD market growth

A recent report predicts the global market for in vitro diagnostics will grow at a compound annual growth rate of more than six percent from 2014 to 2020, reaching a market size of more than $90 billion by the end of 2020.

In the report, the IVD market was segmented on the basis of techniques, products, applications, and end-users. Major factors such as technological advancements in diagnostics, rising health care awareness, growing incidence of chronic and infectious disease, and demand for point-of-care testing devices are boosting the market growth. However, intensified competition, payment issues, and affordability of health care diagnostics are hindering the IVD market’s growth, said the report, released in November by analytical firm Research and Markets.

The molecular diagnostics market segment is expected to register the highest annual growth rate, of more than nine percent from 2014 to 2020. Meanwhile, the reagents market is seen as growing more than seven percent during the forecast period.

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Payers set higher bar for pricey new technology

A recently published study finds that private insurers are rapidly adopting new provider payment models—including pay-for-performance and financial risk-sharing arrangements—and tightening coverage evidence requirements for costly new medical technologies such as diagnostic tests.

The study, based on comprehensive interviews with nine private insurers that insure about 110 million Americans, found that payers are moving toward payment models that can have the effect of discouraging health care organizations from using new technologies that may bring value to patients and the health care system but add to near-term costs (Long G, et al. Journal of Medical Economics. 2014;17:883–893). The research was funded by the Advanced Medical Technology Association, or AdvaMed.

Three years ago, 46 percent of respondents’ beneficiaries were involved in pay-for-performance and financial risk-sharing arrangements, according to Analysis Group, the firm that conducted the study. Now that figure stands at 62 percent and is expected to rise to 75 percent in the next three years. More than half of respondents indicated they have become more selective in approving new technologies over the past three years, and more than 40 percent of respondents believe that in the next three years the evidence requirements for approval of a new technology will be higher still.

“This study dovetails with previous findings by others on declining Medicare coverage approval rates and rising evidentiary thresholds,” AdvaMed CEO Stephen J. Ubl said in a statement. “We need to ensure that new payment models—being adopted by private insurers and Medicare alike—include safeguards that protect patients from potential unintended consequences, whether that be stinting on patient access to care or discouraging innovation.”

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USPSTF: Scant support for routine vitamin D testing

The U.S. Preventive Services Task Force has issued a recommendation saying that the evidence is “insufficient” on screening for vitamin D deficiency in asymptomatic, nonpregnant adults to improve health outcomes and that its benefits and harms cannot be determined (LeFevre ML, et al. Ann Intern Med. Published online ahead of print Nov. 25, 2014. doi:10.7326/M14-2450).

A draft version of the panel’s statement was posted for public comment last summer. In response to the comments, the USPSTF clarified that its recommendation does not apply to special populations, such as patients with bone, endocrine, and immune conditions. Other commenters sought the panel’s advice on tools to help stratify patients for vitamin D deficiency before testing. In the final recommendation, the USPSTF refused to do that because its “systematic review did not evaluate the evidence on risk assessment tools.” But the panel may take on that issue “in future updates of the topic.”

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Imaging IDs receptors for cancer treatment

Researchers at Dartmouth University have developed a fluorescence imaging technique that can identify receptors for targeted cancer therapies in a manner that correlates with findings from tissue biopsy analysis.

“This new technique allows us to accurately determine the amount of protein receptors available for binding a drug without invasive biopsy,” Kimberley S. Samkoe, PhD, assistant professor of surgery at Dartmouth’s Geisel School of Medicine and adjunct assistant professor at Thayer School of Engineering, said in a statement.

Dr. Samkoe is lead author of the article in which the Dartmouth researchers recently reported their findings (Cancer Res. Published online ahead of print Oct. 24, 2014. doi:10.1158/0008-5472.CAN-14-0141).

The researchers developed a dual-tracer in vivo receptor concentration imaging, or RCI, technique that involves the simultaneous injection of a targeted and a nontargeted imaging agent. They then studied the protein expression of five tumors, comparing the RCI data to that determined by clinical immunohistochemistry, either scored by a pathologist (as performed in the clinic) or analyzed independently by a computer. They found that the protein expression determined by RCI strongly correlated to that determined by tissue analysis. They also found that commonly used techniques of measuring protein expression, such as Western blot or flow cytometry, did not correlate to the RCI values, and in fact over-predicted the number of receptors available for therapeutic or diagnostic targeting.

Dr. Samkoe noted that this study looks at the average receptor expression within the tumor. The next step will be to look at tumors on a microscopic level to correlate receptor expression to distinct physiological features such as cellular viability, cellular type, vascularity, and overall tumor architecture.

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ARUP sponsors PLUGS

ARUP Laboratories will collaborate with Seattle Children’s Hospital to help pediatric hospital labs improve ordering practices through the hospital’s Pediatric Laboratory Utilization Guidance Services program, called PLUGS for short.

“We hope our combined efforts will draw additional attention to this critical aspect of laboratory diagnostics,” ARUP vice president and chief medical informatics officer Brian Jackson, MD, said in a statement.

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Roche acquires Ariosa

Roche recently announced the acquisition of Ariosa Diagnostics, a privately held, San Jose, Calif.-based molecular diagnostics testing service provider that offers a noninvasive prenatal test using its cell-free DNA technology.

Ariosa’s proprietary Harmony Prenatal Test is performed as early as 10 weeks into pregnancy. By evaluating fetal cfDNA found in maternal blood, the blood test is designed to assess the risk of Down syndrome and other genetic abnormalities. The test assesses the risk of trisomies 13, 18, and 21, and Ariosa said it is supported by clinical studies in more than 22,000 women of all ages and risk categories. It is not yet for sale as an IVD in the U.S. or the EU.

The transaction was expected to close in December.

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CE mark for Ortho’s Vision

Ortho-Clinical Diagnostics has obtained CE mark for the Ortho Vision Analyzer, a fully automated analyzer for transfusion medicine labs. The analyzer for Ortho Column Agglutination Technologies was set to be commercially available in Europe, Japan, and Australia by the end of 2014.

Designed with secure monitoring technologies for safety checks and balances, the analyzer aims to give transfusion medicine professionals the ability to track every critical automated step in the immunohematology testing process. The analyzer verifies and documents diagnostic checks throughout the sampling process and provides round-the-clock remote data tracking that monitors and ensures instrument performance. Laboratory personnel can log on anytime, anywhere to collaborate on interpreting results in real time, according to the company.

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Quest acquires PhenoPath
November 2018—Quest Diagnostics has acquired PhenoPath Laboratories, which provides immunophenotyping, hematopathology, and molecular pathology services. The PhenoPath business, in Seattle, will operate as part of AmeriPath, a wholly owned business of Quest. Steve Rusckowski, Quest chairman, president, and CEO, said in a statement: “PhenoPath has a strong record of innovation and provides several capabilities that complement and extend our own, particularly in pathology and molecular oncology. It also deepens our presence in the Pacific Northwest.” PhenoPath founder Allen Gown, MD, tells CAP TODAY that continued consolidation in the laboratory industry and insurance reimbursement challenges have posed significant risks to PhenoPath’s future growth. “In Quest/AmeriPath,” he says, “we found an organization that realized not only the excellence of PhenoPath’s past and present but also the extraordinary future that, with their assistance, we can have.” Dr. Gown founded PhenoPath in 1998.

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