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December 8, 2011

In This Issue:

arrowCLSI issues new guidelines on molecular testing, newborn CF screening

arrowDNA sequencing is outpacing data systems

arrowStudy: new multiple sclerosis treatment may utilize immune cells

arrowNew Randox molecular diagnostics test enhances CRC therapy

arrowRoche submits vitamin D assay for FDA clearance

arrowCLIA waiver is granted for TearLab osmolarity system

arrowDark Report audio conference will address code-stack changes

arrowHot Clips: Regulations/Compliance

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CLSI issues new guidelines on molecular testing, newborn CF screening

The Clinical and Laboratory Standards Institute (CLSI) recently published Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline (MM19-A). This document provides comprehensive guidance for planning and implementation of molecular diagnostic testing, including strategic planning, regulatory requirements, implementation, quality management, and special considerations for the subspecialties of molecular genetics, infectious diseases, oncology, and pharmacogenetics. The guideline’s target audience is the stakeholders who play a role in the strategic decision to implement a molecular diagnostic program, including medical and technical directors who may not have previous experience with molecular testing; supervisory technical staff who implement molecular assays for the first time; quality management systems (QMS) groups who will adapt the quality plan to incorporate the unique aspects of the new program; and production staff who will perform and maintain all aspects of the assays.

CLSI has also published Newborn Screening for Cystic Fibrosis-Approved Guideline (I/LA35-A). This document describes the use of newborn screening laboratory tests for detecting risk for cystic fibrosis from newborn dried blood spots (DBS) and addresses both the primary screening tests and the reflex tests performed on DBS. Cystic fibrosis, a relatively common genetic disorder, is due to mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Early diagnosis through newborn screening is now practiced throughout the United States, Australia, western Europe, and Canada. Read the molecular testing guidelines, and learn more about the CF guidelines.

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DNA sequencing is outpacing data systems

Genomics research organizations are churning out data on thousands of human DNA sequences a day, and the issue of how to communicate the information to clients is becoming a significant problem. Internet communication, counter-intuitive as this might sound, is too slow; some companies are over-nighting CDs to clients instead. The challenge of storing and transmitting the data is matched as well by that of analyzing it, as clients struggle to keep up with a deluge of data. Cost is an issue too; sequencing costs are declining toward the goal of determining a patient’s DNA blueprint for less than $1,000, but the cost of analyzing the data is not going down. One scientist, David Haussler, director of the Center for Biomolecular Science and Engineering at the University of California, Santa Cruz, expressed the problem succinctly: “It costs more to analyze a genome than to sequence a genome.”

Experts in bioinformatics—the area of specialization that links biology and computer science—are working on ways to resolve the problem, a classic example of rapid advances in one technology not having been matched by corresponding advances in a related technology. When solutions are found, the long-awaited day when DNA sequencing is used routinely in diagnosis and treatment of patients could be near. To learn more about the problem and proposed solutions, visit a New York Times article that covers the topic comprehensively.

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Study: new multiple sclerosis treatment may utilize immune cells

A study to be published in the January 2012 issue of the American Journal of Pathology suggests that laquinimod, a synthetic compound that is available orally, may have therapeutic value for relapsing-remitting multiple sclerosis (RRMS). In phase II/III clinical studies, laquinimod triggered immune cells in the central nervous system to produce brain-derived neurotrophic factor (BDNF). Neurotrophins such as BDNF, which are essential to the production and functioning of neurons and axons, are mainly produced by neurons, but BDNF is also secreted by some types of immune cells. Stimulating those cells to produce more BDNF could contribute to the survival of, or even repair, neurons in patients with MS, therefore reducing the amount of brain damage associated with the disease.

Researchers explored laquinimod’s capacity for neuroprotection by monitoring levels of BDNF in the serum of RRMS patients who had been treated with the compound. They found elevated levels of BDNF in 76% of patients who had been so treated. In some patients, BDNF serum levels increased by a factor of 11. In addition, the elevation in BDNF did not appear to correlate with other factors such as relapse rate, age, gender, or baseline disability. The researchers also experimented with animal models to corroborate their findings with human patients. Here is an abstract of a paper on this intriguing topic.

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New Randox molecular diagnostics test enhances CRC therapy

Colorectal cancer (CRC) is the third most common cancer worldwide. Metastatic disease accounts for 40-50% of newly diagnosed patients and is associated with high morbidity. Despite recent therapeutic advances, the prognosis for metastatic CRC remains poor. Early diagnosis and assignment of the most appropriate therapy pathway is therefore crucial. The KRAS/BRAF/PIK3CA Array from Randox allows the clinician to select appropriate patients for anti-EGFR therapy, maximizing drug efficacy and minimizing adverse side effects to the patient.

Monoclonal antibodies (MoAbs) targeting the epidermal growth receptor (EGFR) have proven effective in combination with chemotherapy or as single agents for treatment of mCRC. However, only a subset of patients with mCRC clinically benefit from EGFR-targeted moAbs. Mutations in the KRAS gene are known to disrupt the EGFR pathway, rendering the anti-EGFR therapy ineffective. Presence of KRAS mutations accounts for approximately 35 to 45% of non-responsive patients. Oncogenic mutations in genes encoding key downstream effectors within the EGFR signaling pathways may also be responsible for resistance to EGFR-targeted moAbs. Mutations within the BRAF and PIK3CA genes have now been reported to affect patient response to EGFR-targeted moAbs. The KRAS/BRAF/PIK3CA Array is designed for the rapid qualitative detection of point mutations within the genes KRAS, BRAF and PIK3CA from tissue DNA. A single DNA sample is required for testing, with results obtained in three hours. Review scholarly articles related to the KRAS/BRAF/PIK3CA Array.

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Roche submits vitamin D assay for FDA clearance

Roche announced on December 5 that it has filed a 510(k) submission to the U.S. Food and Drug Administration (FDA) for a fully automated, total vitamin D assay (25-hydroxyvitamin D) for use on Roche's full portfolio of laboratory analyzers. The Elecsys vitamin D test can be combined with routine testing on existing Roche immunoassay analyzers and integrated chemistry/immunoassay systems, enabling labs to address the growing demand for vitamin D testing while maximizing their productivity. According to the National Institutes of Health Office of Dietary Supplements, the serum concentration of 25(OH)D is the best indicator of vitamin D status. It reflects both vitamin D produced cutaneously (D3) and obtained from food and supplements (D2 and D3).

The ability of an assay to detect both D2 and D3 forms (total vitamin D) is important for physicians who have patients taking vitamin supplements. The assay is designed for use on all Roche immunoassay systems for low-, mid- and high-volume testing environments, including the Elecsys 2010, cobas e 411, cobas e 601, cobas e 602 and MODULAR ANALYTICS E170 analyzers. The FDA has a 90-day period after the 510(k) submission for substantive review of the application. Learn more about Roche’s Elecsys systems.

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CLIA waiver is granted for TearLab osmolarity system

TearLab Corporation announced December 5 that the U.S. Food and Drug Administration, based on a supervisory review of the company's appeal, has granted its petition for a waiver under CLlA for the TearLab Osmolarity System. Upon TearLab’s submission of labeling acceptable to the FDA, the CLIA waiver will be issued.

Elias Vamvakas, TearLab's Chief Executive Officer, commented on the importance of the waiver to his company and its customers. "We believe that in order for the TearLab Osmolarity System to become widely adopted, it is essential that it be accessible at the point-of-care. Now, with the CLIA waiver obstacle overcome, this groundbreaking test is free to start growing to its potential."

The TearLab Osmolarity System uses a novel lab-on-a-chip approach that requires less than 50 nL (nanoliters) of tear fluid in order to measure tear osmolarity. The TearLab Osmolarity System eliminates the challenges that previously prevented point-of-care osmolarity testing. The TearLab System can produce a sample-to-answer result in less than 30 seconds. To learn more about TearLab, osmolarity, dry eye disease, and the CLIA waiver, visit TearLab’s home page.

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Dark Report audio conference will address code-stack changes

Is code-stacking about to come to an end? On March 1, 2012, proposed changes will take effect for code-stacked claims in Medicare’s J1 region. That is, one of Medicare’s largest carriers is proposing new processes that will affect claims for molecular diagnostic tests and laboratory-developed tests. This milestone development has the potential to affect every laboratory that uses code stacks when submitting claims for MDTs and LDTs. You and your lab team can get first-hand information about why these proposals were put forth, along with specific details about how Palmetto GBA plans to implement the two proposed MDTs and LDTs. Read on.

On December 20, at 1 p.m. Eastern time, the Dark Report will conduct an audio conference on the subject “How Proposed Code-Stack Changes Will Impact Palmetto GBA’s Handling of Molecular Diagnostic Tests and LDTs.” Robert L. Michel, editor of The Dark Report and, will moderate the discussion. Distinguished presenters are Elaine K. Jeter, MD, Palmetto J11 Medical Director, and Mike Barlow, Vice President of Jurisdiction 1 A/B MAC Operations at Palmetto GBA. Participating in the audio conference will earn you ACCENT Continuing Education Credit. The American Association of Clinical Chemistry (AACC) has designated this program for a maximum of 1.5 ACCENT credit hours towards the AACC Clinical Chemist’s Recognition Award. Click on the Dark Daily link for more information, including registration information.

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HOT CLIPS: Regulations/Compliance - Top Picks

Click on the highlighted links below to discover the top MLO archival properties concerning regulations/compliance, a topic that is now at the forefront of healthcare discussions.

  1. Form an effective compliance program
  2. Growth, complexity of molecular testing drive need for quality controls
  3. Laboratory rep “rules of the road”
  4. Defining accuracy and precision

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