College of American Pathologists
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February 2011

News read or heard lately

Keys to a world-class oncology program

Subspecializations in cancer diagnostics and pathology are one of the seven things that make the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins outstanding, says Kimmel Cancer Center chief administrative officer Terry Langbaum. The Kimmel Cancer Center was one of 30 oncology programs featured recently in Becker’s Hospital Review for exceptional cancer research and treatment.

Langbaum said, “When you put all that expertise into one place, you end up with better diagnostics and staging, which results in a better treatment plan.” According to Langbaum, the Kimmel Cancer Center’s narrow and specific subspecialties in cancer diagnostics and pathology are one of seven characteristics that make the program stand out.

The remaining six:

  • Multiple sets of eyes and minds treating each case.
  • A Comprehensive Cancer Center designation by the National Cancer Institute.
  • A nursing staff that is rigorously trained in oncology care.
  • The view that cancer is a continuum with no room for weak spots.
  • Support services (financial, social, education, housing, and more) that recognize nonclinical patient needs.
  • The number and nature of clinical trials offered.

WHO gives nod to rapid TB test

The World Health Organization endorsed Cepheid’s Xpert MTB/RIF tuberculosis test, which generates a result in about 100 minutes. The fully automated nucleic acid amplification test was developed by Cepheid and the nonprofit Foundation for Innovative and New Diagnostics, or FIND.

The endorsement follows 18 months of assessment of the test’s effectiveness in the early diagnosis of TB, multidrug-resistant TB (MDR-TB), and TB complicated by HIV infection. Xpert MTB/RIF is a “while you wait” test that incorporates DNA technology and can be used at the point of care.

Evidence indicates that implementing the test could result in a threefold increase in the diagnosis of patients with drug-resistant TB and a doubling in the number of HIV-associated TB cases diagnosed in areas with high rates of TB and HIV.

The test’s co-developer, FIND, has negotiated with Cepheid a 75 percent reduction in the test’s price, compared with the current market price, for countries most affected by TB. Preferential pricing will be granted to 116 low- and middle-income countries where TB is endemic, with an additional reduction in price once there is sufficient volume of demand. The current price for each Xpert MTB/RIF test cartridge is $16.86. Once 1.7 million tests are ordered, the price will be reduced to about $14 per test.

The WHO is now calling for the test to be rolled out under clearly defined conditions and as part of national plans for TB and MDR-TB care and control.

Warfarin, tamoxifen genetic test use

When physicians and patients are informed about testing choices and the process is made convenient, genetic tests are adopted at higher rates, according to data from the Medco Research Institute, a subsidiary of Medco Health Solutions.

The use of genetic testing in patients on warfarin and tamoxifen has been low in routine practice. But according to the analysis, when a proactive pharmacy-based pharmacogenomic testing program was implemented, the incidence of testing in patients on warfarin was nearly 45 times higher and among patients on tamoxifen nearly seven times higher as compared with the pre-program time period.

The testing program identified appropriate patients for testing, informed physicians and patients about the genetic tests and gained their consent for testing, coordinated the collection and shipment of DNA samples to a qualified laboratory, and communicated test results and interpretation of those results to physicians.

The analysis found that when genetic testing was considered potentially appropriate, physicians gave their consent for testing for 49 percent of their patients using warfarin and for 54 percent of their patients using tamoxifen. Additionally, the program led to patient consent for testing in 39 percent of patients on warfarin and 56 percent of patients using tamoxifen, among those considered potentially appropriate for testing.

More details about the analysis and its results can be found at

Prometheus and UCLA to validate biomarkers for IBD

Prometheus Laboratories and the Regents of the University of California, Los Angeles campus, have executed a research agreement that will focus on identifying biological markers of mucosal healing in patients with inflammatory bowel disease. Jonathan Braun, MD, PhD, chair of the Department of Pathology and Laboratory Medicine and professor of molecular and medical pharmacology, UCLA David Geffen School of Medicine, will lead the research.

Using a cross-sectional study design, Dr. Braun’s laboratory will determine the correlation of genotoxicity markers to mucosal healing and disease activity in IBD patients. Prome-theus will evaluate in its laboratory additional markers of inflammation and other markers traditionally associated with the diagnosis and prognosis of IBD.

Under the terms of the deal, Prometheus will fund the research activities in Dr. Braun’s laboratory in exchange for rights to intellectual property generated as a result of the project. Prometheus holds a license to technology Dr. Braun co-invented, and Dr. Braun is a co-founder of Prometheus.

New food allergy guidelines

New guidelines from an expert panel sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) aim to standardize the diagnosis and management of food allergies across clinical care settings.

The recommendations, published in the December 2010 issue of the Journal of Allergy and Clinical Immunology, are meant to be easily understood and implemented by clinicians in varied specialties, according to the NIAID’s Matthew Fenton, PhD, who was one of the primary authors and led the guidelines development project.

NIAID worked with 34 professional organizations, advocacy groups, and federal agencies to convene a panel of 25 experts that reviewed more than 400 studies in drafting the guidelines, which include 43 recommendations.

The guidelines call for the use of medical history and physical examination to aid in the diagnosis of food allergies and to confirm patient-reported food allergies.

The recommendations also address the use of multiple types of tests for reaching a diagnosis for IgE-mediated food allergy:

  • A skin-prick test should be used to identify foods that may provoke an allergic reaction, but it cannot stand alone for diagnosis. Intradermal testing and routine use of measuring total serum IgE should not be used to make a diagnosis.
  • Allergen-specific IgE tests should be used to identify foods that could potentially provoke allergic reactions but are not diagnostic of food allergy alone.
  • An atopy patch test should not be used in routine evaluation of non-contact food allergy.
  • A combination of skin-prick tests, allergen-specific IgE tests, and atopy patch tests should not be used for routine diagnosis.
  • Several nonstandardized and unproven procedures should not be used for diagnosis, including the allergen-specific IgG4 test that some clinicians use.
  • Oral food challenges should be used for diagnosing food allergy. A double-blind, placebo-controlled food challenge is the gold standard, but a single-blind or open food challenge may be considered diagnostic in two cases: If either of these challenges elicits no symptoms, then food allergy can be ruled out. But when either type of food challenge elicits symptoms consistent with medical history and are supported by lab tests, then a diagnosis of food allergy is supported.

NinePoint Medical to develop in vivo pathology platform

NinePoint Medical has completed a $33 million series A financing, which will be used to develop an in vivo pathology technology platform. NinePoint, located in Cambridge, Mass., intends to use the platform to develop and commercialize medical devices for diagnosing dysplastic, precancerous, and cancerous cells.

NinePoint’s initial focus will be developing devices for the examination of the gastrointestinal tract. The devices will be designed to allow gastroenterologists and off-site pathologists to review advanced tissue images during biopsies and other therapeutic and diagnostic procedures in real time. This capability would potentially provide physicians with immediately actionable information, and, eventually, the ability to treat the questionable cells at the time of diagnosis.

By streamlining the timeline and the steps required to go from diagnosis to treatment, the company aims to improve patient experiences and outcomes, make care more efficient, and save the health care system money.

Ambry Genetics launches Illumina HiSeq 2000 sequencing services

Ambry Genetics has officially launched its Illumina HiSeq 2000 next-generation sequencing services.

“We’ve continued to invest in and develop our sequencing operations to become Illumina experts,” said Ardy Arianpour, vice president of business development at Ambry Genetics. He said customers are excited about the Illumina HiSeq because it expands whole genome and exome sequencing services to the next level and gives them the opportunity to reduce their costs while providing more data.