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Lab Worker Dies After Infection

An infectious disease researcher at San Francisco Veterans Affairs Medical Center died Saturday after being infected with Neisseria meningitides, the bacterium he worked with in the lab, reports the San Jose Mercury News. The man, whose name was not released, had been investigating a vaccine against the bacteria. "He left the lab around 5 pm" Friday, says Harry Lampiris, the chief of the infectious diseases division at the VA. "He had no symptoms at all." The San Jose Mercury News adds that the man began feeling ill about two hours later.

The California Occupational Safety and Health Administration is investigating the death and the safety protocols at the lab, and the Centers for Disease Control and Prevention and local officials are also looking into what occurred, the Mercury News adds.

May 03, 2012

New Space

Provista Diagnostics has opened a new, 13,611 square-foot laboratory in Scottsdale, Ariz., the company announced. Provista develops diagnostics to detect early-stage cancers. The new space will be home to the company's Provista Dx Reference Laboratory, which is CLIA-accredited, and offers clinical diagnostic services as well as contract research and biopharmaceutical testing services. "The new facility … will offer a comprehensive menu of testing services, including custom projects," the company adds.

In addition, Provista announced that Sherri Borman is its new clinical laboratory director, and in that capacity she will oversee the new lab.

May 02, 2012

This Week in the Journal of Clinical Pathology

In the Journal of Clinical Pathology this week, UK researchers report on the prognostic significance of early stage lymph node positivity in operable invasive breast carcinoma. The team based its study on a series of 3,491 consecutive operable breast cancer cases, which were given the standard treatment of care and then followed up on long term. They found that lymph node stages and absolute number of lymph nodes was associated with both breast cancer-specific survival and distant metastasis-free survival. "In the pN1 stage, patients with three positive lymph nodes show shorter breast cancer specific survival and shorter distant metastasis free survival when compared with one and/or two positive nodes," the authors write. "This effect is noted in the whole series as well as in different subgroups based on tumor size, histological grade, vascular invasion, and estrogen receptor status."

Also in the Journal of Clinical Pathology this week, researchers in Australia and Belgium report their molecular characterization of unusual subcutaneous spindle cell breast lesions. The team studied DNA copy-number alterations in a rare tumor called differentiating dermatofibrosarcoma protuberans, and found copy number changes on chromosome 1 and amplification of chromosome 7p. "This case of an unusual DFSP demonstrates that genomic interrogation provides additional potential targets such as a therapeutic avenue with anti-EGFR therapies and shows the power of molecular characterization of unusual tumors for a personalized medicine approach," the authors write.

May 02, 2012

A New Number

Quest Diagnostics is assigning 16-digit identification numbers to each of its patients, the company says in a press release. Identifiers have been assigned to about 80 million Quest patients so far, and the company says such patient IDs will help "speed and streamline access to critical patient records."

"Patients can use their unique Health ID to gain timely access to their personal laboratory test results, to help develop a picture of the most appropriate treatment options," says Surya Mohapatra, Quest's CEO, in a statement.

May 01, 2012

This Week in Modern Pathology

Researchers led by Martha Wood from Mount Sinai Hospital in Toronto discuss genetic heterogeneity of HER2 status in Modern Pathology. The researchers examined 2,522 breast cancer tumors that were tested for HER2 amplification using fluorescence in situ hybridization. By definition, HER2 amplified tumors have a ratio of HER2 to a chromosome 17 probe that is greater than 2.2. Of those 2,522 cases the researchers studied, 26 percent were genetically heterogeneous. Most of those heterogeneous cases had a non-amplified ratio, 64.5 percent, while 4 percent were amplified. "In conclusion, definitions of 'genetic heterogeneity' in HER2 FISH testing that depend only on the percentage/proportion of amplified cells are not informative of heterogeneity within a tumor population," Wood and her colleagues write. "Rather, the percentage of amplified cells varies with the HER2/CEP17 ratio in a predictable statistical manner. Current definitions of 'genetic heterogeneity' should be reassessed."

Also in Modern Pathology, French researchers evaluate different approaches to determine HER2 status from breast core-needle biopsies. The researchers examined the concordance of HER2 status calls made by immunohistochemistry and silver or chromogenic in situ hybridization on core-needle biopsies with HER2 status determined by fluorescence in situ hybridization on surgical samples, and drew upon 196 cases from 20 histopathological laboratories. "Immunohistochemistry status assessed on cores biopsy is highly concordant with FISH in cores and surgical specimens," the researchers write. "Furthermore, CISH and/or SISH even represents a safe alternative method to determine HER2 status on these cores biopsies to confirm any ambiguous immunohistochemistry results (2+) or to perform HER2 status screening, if ISH is used as first-line screening method." In its paper, the team notes that Roche provided financial support for this work and also managed the study and statistical analysis.

May 01, 2012

This Week in Clinical Chemistry

In Clinical Chemistry this week, researchers in Sweden report on a role for plasma prolylcarboxypeptidase in obesity and diabetes, and the association of its concentration with signs of cardiovascular dysfunction. The team purified PRCP from human neutrophils from three cohorts of study participants: 40 healthy individuals, 165 people with chest pains, a community-based cohort of 1,004. "PRCP was purified to homogeneity. Mean plasma concentrations in healthy individuals were 12.9 (3.2) μg/L and were increased in patients with chest pain and in patients with obesity and/or diabetes mellitus," the authors write. "The associations of PRCP concentrations with signs of cardiovascular dysfunction and cardiovascular abnormalities suggest a pivotal role of the enzyme in disease."

Also in Clinical Chemistry this week, researchers in Finland measure hyperglycosylated human chorionic gonadotropin in the serum of testicular cancer patients. The team determined serum concentrations of hCG-h, hCG, and the free β subunit of hCG in 176 serum samples from 84 testicular cancer patients. The researchers found that a large proportion of hCG was hyperglycosylated in the pre-operative patients, at relapse, and shortly after treatment. "The serum concentrations of hCG-h and hCG correlated strongly with each other and had similar diagnostic value," the authors write. "The preoperative serum concentration of hCG-h correlated with prognostic factors and outcome in the same way as hCG. Increased preoperative hCGβ concentration predicted shorter progression-free survival."

April 30, 2012

Eye on Systems Biology

Advances in systems biology research "could greatly expand the need for multiplex testing performed by clinical laboratories," says Dark Daily's Pamela Scherer McLeod. "Despite the complexity of human metabolic systems, experts in systems biology are making progress in identifying the myriad of metabolic channels that collectively can be used to diagnose disease and identify appropriate therapies," she says. "These are auspicious developments for medical laboratory managers and pathologists."

While clinical lab managers and pathologists are already familiar with many of the technologies systems biologists are using (like microarray analysis and multiplex qPCR), McLeod says that new technologies that "analyze systems-level datasets that connect numerous biomarkers and pathways to biological states" are on the horizon. "Stories about advances in systems biology and the expected outgrowth of multiplex testing are early evidence for pathologists and clinical laboratory managers that this scientific field is moving steadily toward clinical applications," she writes.

April 27, 2012 / 1 comment

This Week in The Journal of Pathology

In a paper published online in advance in The Journal of Pathology, a team led by investigators at the Wellcome Trust Sanger Institute presents an analysis of ovarian cancer rearrangements. The team compares the high grade serous and clear cell histotypes with other solid cancers using paired-end next generation sequencing for each. "Somatic rearrangements were systematically characterized in eight high grade serous and five clear cell ovarian cancer genomes and we report here the identification of more than 600 somatic rearrangements," the authors write, adding that "comparison to breast, pancreatic and prostate cancer genomes revealed that a subset of ovarian cancers share a marked tandem duplication phenotype with triple-negative breast cancers." Further, based on its observations, the team suggests that BRCA1/2 germline mutations may contribute to "widespread structural change" in the triple-negative breast and ovarian cancer genomes.

Researchers at the Vanderbilt University Medical Center present evidence to suggest that "Fus1 establishes its immune and tumor suppressive activities via regulation of mitochondrial homeostasis." In a mouse model of asbestos-induced peritoneal inflammation, the team sought to investigate how Fus1 modulates inflammatory response and mitochondrial function. In a separate experiment, the team observed "Fus1-dependent basal and asbestos-induced changes in major mitochondrial parameters (ROS production, mitochondrial potential, and UCP2 expression) in Fus1-/- immune cells and in Fus1-depleted cancer cells," as it writes in The Journal of Pathology.

April 27, 2012

Waiting Around

While many new lab technologies aim to have faster turnaround times, Jon Faro from the University of Texas Health Sciences Center writes at Medical Laboratory Observer that "rapid tests have shortcomings — in complexity, in expense, and in some instances in 18-hour overnight enrichment periods — that have left the healthcare community wanting more." While PCR is faster than cell culture for microbial diagnostics, Faro says it is not always the best method, citing long prep times, the need for fresh samples, as well as special equipment and reagents, among others. Some companies are stepping in, he says, with adenosine triphosphate-based assays or phenotype microarrays. NanoLogix, a company Faro has worked with, uses an advanced-culture-based approach that he says is both speedy and specific. "Over the next few years, it can be expected that more novel rapid approaches will surface and lead towards the more accurate, rapid, and efficient diagnostics that more effectively equip healthcare providers to fight infectious diseases," Faro writes.

April 26, 2012

This Week in Experimental and Molecular Pathology

In Experimental and Molecular Pathology, researchers led by Kiho Cho from the University of California, Davis, report having studied whether structural changes to the genome depend on age and organ tissue. Using real-time PCR, the researchers examined the copy number of GAPDH, HPRT, and mitochondrial DNA addition to determining the copy number of four retroelements from different tissues from mice of various ages. Cho and his colleagues found that liver genome size was larger than the other tissues and that the size increase was associated with more copies of the retroelements. "This study provided a series of evidence that the structure of the C57BL/6 J mouse genome changes temporally (age-dependent) and spatially (tissue-specific) implying that the genome has a highly dynamic property and is polymorphic in nature," the researchers write.

Researchers from Harbin Medical University looked into the role of Shp-2 in apoptosis, with a particular interest in its relation to cell death during cardiac ischemia and heart disease. The team found that "the inhibition of Shp-2 was responsible for increased apoptosis in neonatal cardiomyocytes," it writes. "Second, the overexpression of Shp-2 attenuated apoptosis via ERK activation, and the effect of Shp-2 was abolished by treatment with a MEK inhibitor."

April 26, 2012

Repeat Test

Quest Diagnostics has a new test for amyotrophic lateral sclerosis, the company announced. The test examines hexanucleotide repeat expansion in the C9orf72 gene. A recent Lancet Neurology paper, the company notes, found this expansion in up to 39 percent of familial ALS cases and in 4 to 8 percent of sporadic ALS. The test is being offered by Quest's Athena Diagnostics business unit. "We believe C9orf72 testing has the potential to significantly enhance the quality and speed of diagnosis for many patients under evaluation for this disorder," says Jeff Weisberg, the vice president and general manager for Athena Diagnostics, in a statement.

April 25, 2012

This Week in the Journal of Clinical Pathology

The Université de Nantes' Céline Bossard and colleagues discuss KRAS mosaicism in metastatic colorectal adenocarcinomas in the Journal of Clinical Pathology. The researchers examined 18 patients with metastatic colorectal cancer and determined the mutational status of their tumors — including primary tumors, synchronous and metachronous metastases, and a recurrence — through PCR and direct sequencing. Bossard et al. report that KRAS mutational status agreed between primary tumors and matched metastases for 14 of the 18 patients, though it did not agree in four. "In some patients, we were able to detect a KRAS mutation in the primary tumor but not in matched metastases, and a KRAS mutation in some metastases but not in others. These findings can be explained by the successive and/or parallel clonal expansions at intermediate stages during the multistep evolution of the tumor," the researchers write.

In an opinion article, the University of Western Australia's David Ravine and the University of Adelaide's Graeme Suthers say there is not enough information regarding the risk of preanalytical errors in genetic testing. "Like the proverbial elephant in the room, we know the errors are present but we hesitate to talk about them. The issue must be addressed, however, because errors in genetic testing have the potential to prompt clinical decisions with a high risk of attendant harm," Ravine and Suthers write.

April 25, 2012

Time to Comply

Under a rule proposed by the US Department of Health and Human Services, clinical labs would have to send test results directly to patients if the patients request them, reports Bill Malone in this month's Clinical Laboratory News. Attorney Joshua Freemire tells Malone that compliance may be an issue — while many large labs already offer such access, others might not have the necessary procedures in place yet. Malone also notes that Alan Mertz, president of the American Clinical Laboratory Association, has asked HHS to give labs a year to comply with such new rules. "Some laboratories lack policies, protocols, and mechanisms for responding to requests for access to test reports, for addressing follow-up questions from patients, or for providing patients with direct access to test reports. Such laboratories will have to establish new procedures and new software systems to accommodate the proposed changes," Mertz wrote to HHS.

April 24, 2012