College of American Pathologists
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CAP Today




November 2012

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In Cleveland Clinic’s top 10 innovations: mass spec for bacterial ID

Matrix-assisted laser desorption/ionization—time-of-flight mass spectrometry (MALDI-TOF), a technology that enables bacteria to be identified in minutes rather than days, is No. 3 on the Cleveland Clinic’s top 10 list of medical innovations expected to improve patient care within the next year.

“It’s a technique that is novel because it uses a mass spectrometry technique to identify bacteria, and the desorption part of it uses a special buffer that protects the molecules from complete destruction,” Kandice Kottke-Marchant, MD, PhD, chair of the Cleveland Clinic’s Pathology and Laboratory Medicine Institute, told CAP TODAY. With bacteria, she says, it is the proteins that are being looked at—huge molecules with large molecular weights. “The MALDI is a more gentle mass spec that can analyze whole proteins,” she says.

Dr. Kottke-Marchant says it’s the marriage of protein-pattern recognition (for each type of bacteria) databases to MALDI-TOF technology that enables quick, accurate identification of specific bacteria. “You can put this [culture sample] in the mass spectrometer and within minutes get an identification of the type of bacteria based on this protein-pattern recognition, or this molecular signature. Comparing the molecular signature with the database provides a high degree of certainty for the identity of the organism you’ve got in the sample.”

With the databases very good now for bacteria, one hope with MALDI-TOF, Dr. Kottke-Marchant says, is that as users get more experience and development continues, “we’ll be able to use databases for different types of microorganisms—mycobacteria, like TB, or fungi, yeast, and maybe even viruses.” And though MALDI-TOF instruments are expensive, the cost to operate them is relatively small, she says, citing an estimated cost per test of less than a dollar and the possibility for smaller labs to use MALDI-TOF mass spec someday to in-source organism identification.

The clinic’s own MALDI-TOF mass spectrometer was delivered at the end of October, to be used clinically when validation and other lab procedures have been completed.

Of the top 10 list, Dr. Kottke-Marchant said: “It’s a tribute to the important role of pathology and lab medicine in patient care that we’re able to get one of the top three [spots] this year.” DNA sequencing was No. 5 on the clinic’s list for 2012.

Others at the top of the list for 2013 are bariatric surgery to control diabetes, a neuromodulation device for cluster and migraine headaches, new drugs for advanced prostate cancer, and a handheld optical scan for melanoma.

Life Tech cancer panels to be paired with CollabRx interpretive analytics

CollabRx on Oct. 3 announced a multi-year partnership with Life Technologies for development and commercialization of CollabRx technology and content resources to be used in conjunction with Life Tech’s cancer diagnostics development and its laboratory-developed test services business.

“Molecular analysis, including genetic sequencing, is increasingly becoming an important part of the clinical management of cancer patients,” James Karis, co-CEO of CollabRx, said in a statement. The volume and complexity of genetic data being produced, particularly in the course of therapy development, Karis said, is outpacing physicians’ ability to stay current and understand how to apply the genetic data to treat their patients.

CollabRx, a data analytics company focused on genomics, bridges this knowledge gap using cloud-based expert systems to inform health care decisionmaking by aggregating knowledge of molecular medicine and putting it into context with insights from the nation’s top clinical experts.

Life Tech will use CollabRx’s proprietary content and technology to pair the results of Life-Tech-developed molecular profiling panels with associated clinically relevant and dynamically updated knowledge on clinical trials, drugs, biologics, and other information relevant to cancer treatment planning. While CollabRx and its advisors do not provide specific treatment recommendations, this clinically relevant knowledge is a key part of the “context engine” for informing health care decisionmaking.

George Lundberg, MD, is editor-in-chief of CollabRx and chair of its editorial advisory board, of which former CAP president Jared Schwartz, MD, PhD, is a member. Pathologist Victor Prieto, MD, PhD, is a member of the melanoma editorial board.

Quest to buy UMass outreach lab

Quest Diagnostics on Oct. 16 signed a definitive agreement to purchase UMass Memorial Medical Center’s clinical outreach laboratory business. UMass Memorial, Worcester, is a member of UMass Memorial Health Care in Central New England.

The sale is the first step in establishing a long-term relationship between the two organizations that could result in UMass Memorial taking a financial stake in a new business Quest will form that will develop and operate a new laboratory in Massachusetts.

Quest’s full-service lab in Cambridge, Mass., and its Athena Diagnostics specialty neurology testing subsidiary in Worcester will move to the new facility. In the new lab, when it’s fully operational, will be the testing performed now in both of those labs as well as the testing performed in UMass Memorial’s outreach laboratory. The full transition of services is expected to take place over the next 18 to 24 months. Quest has signed a nonbinding letter of intent to lease property in Marlborough, Mass., to house the new laboratory.

NCI awards grant to PrimeraDx to develop B-cell lymphoma panel

The National Cancer Institute-sponsored Innovative Molecular Analysis Technologies program has awarded PrimeraDx a grant to develop an assay to rapidly detect diffuse large B-cell lymphoma (DLBCL) subgroups.

This single-tube gene-expression profiling assay will be used to classify DLBCL subgroups, thereby facilitating rapid diagnosis, enabling treatment options to be chosen, and making it possible to predict the likelihood of response to therapy and of survival.

The assay will be developed on PrimeraDx’s IcePlex, a multiplexed, automated real-time PCR platform that uses formalin-fixed paraffin-embedded (FFPE) specimens.

“In the clinic today, there is an unmet need for quantitative, multiplexed, sensitive, and robust assays that can use FFPE as a source of tissue for genetic analysis,” Matt McManus, MD, PhD, president and CEO, PrimeraDx, said in a statement. “This award from the NCI is an important recognition of the IcePlex system’s capabilities in oncology diagnostics. Developing this assay will significantly advance the ability to translate tumor biology into actionable clinical diagnoses.”

CellaVision, Siemens reach deal for digital microscopy hematology solutions

CellaVision and Siemens Healthcare Diagnostics have signed a supply, distributorship, sales, and service agreement through which Siemens can offer its clinical laboratory customers access to CellaVision’s digital microscopy hematology products. The deal will become effective on Jan. 1.

CellaVision’s product line is complementary to Siemens’ hematology portfolio. Hematology products covered in the agreement, such as CellaVision’s DM96 and DM1200, are used for automated medical microscopy analysis. CellaVision technology automates digital cell morphology, in which cells are automatically located on a stained peripheral blood or body fluid smear, classified, stored, and presented for confirmation by a technologist.