Healthcare News

A Weekly Compilation of Clinical Laboratory and Related Information
from The Division of Laboratory Science and Standards

October 31, 2013

News Highlights

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HHS Announces Development of Novel Anthrax Infection Blood Test

The U.S. Department of Health and Human Services announced on Monday that it will support the development of a rapid blood test for anthrax infection detection to increase response capability during an anthrax attack. The Biomedical Advanced Research and Development Authority will assist the development of the rapid blood test. The test must first gain approval from the U.S. Food and Drug Administration.
“This project is the first that BARDA will sponsor to develop new diagnostics for biothreats for use during public health emergencies,” BARDA Director Robin Robinson said. “Quickly identifying people exposed to anthrax is crucial to providing appropriate care.”

Source: http://www.bioprepwatch.com/

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Broad Gets Massachusetts Approval to Sequence Clinical Samples Under CLIA

The Broad Institute has obtained approval from the state of Massachusetts to start processing clinical samples under CLIA, the institute said today. After passing inspection by the state, the Broad has completed "a critical step on the path toward establishing a Clinical Research Sequencing Platform," according to a statement from the institute, and can now perform clinical testing, including sequencing, on patient samples. In addition, CRSP plans to provide sequencing compliant with CLIA, CAP, and the FDA's Quality Systems Regulations, as well as technical expertise, to support clinical research, such as clinical trials by groups in academia and industry that require genomic sequence information.

Source: http://www.genomeweb.com/

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Hepatitis C Testing Bill Signed by Governor Cuomo

New York State’s Governor Andrew Cuomo signed a new hepatitis C (HCV) testing bill today in an effort to protect baby boomers. The new AARP-backed law, and sponsored by Senate Health Committee Chairman Kemp Hannon (R-Nassau) and Assemblyman Kenneth Zebrowski (D-New City), which is the first of its kind in the US, requires all providers in all clinical settings in the state of New York, except emergency rooms, to offer a one-time hepatitis C test to all residents born between 1945 and 1965. The law will take effect as of January 1, 2014.

Source: http://blog.timesunion.com/

Illumina Announces Launch of Trugenome Undiagnosed Disease Test

Illumina, Inc. (NASDAQ:ILMN) today announced the launch of its TruGenome Undiagnosed Disease Test provided by the CLIA-certified, CAP-accredited Illumina Clinical Services Laboratory (ICSL). This new service uses whole human genome sequencing to assist physicians in identifying the underlying genetic cause of a rare or undiagnosed disease. By providing physicians with more comprehensive information from a single test, the service enables a broader understanding of the genetic basis for disease.

Source: http://www.news-medical.net/

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Researchers Discover New Avenue for Preventing and Treating Fatal Prion Disease

Case Western Reserve University researchers have published findings that point to a promising discovery for the treatment and prevention of prion diseases, rare neurodegenerative disorders that are always fatal. The researchers discovered that recombinant human prion protein stops the propagation of prions, the infectious pathogens that cause the diseases.
Recombinant human prion protein is generated in E. coli bacteria and it has the same protein sequence as normal human brain protein. But different in that, the recombinant protein lacks attached sugars and lipids. In the study, published online in Scientific Reports, researchers used a method called protein misfolding cyclic amplification which, in a test-tube, mimics the prions' replication within the human brain. The propagation of human prions was completely inhibited when the recombinant protein was added into the test-tube. Recombinant Human Prion Protein Inhibits Prion Propagation in vitro

Source: http://www.medicalnewstoday.com/

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Breath Test Detects Lung Cancer

An advanced colorimetric sensor that analyzes breath can accurately identify lung cancer and characterize cancer histology, researchers report. "We have certainly discovered a biomarker, but we still have a lot of work to do in technical validation and clinical validation," explained Peter Mazzone, MD, director of the lung cancer program at the Respiratory Institute at the Cleveland Clinic.
Dr. Mazzone presented the research here at CHEST 2013: the American College of Chest Physicians Annual Meeting. He underscored the need for tools that can improve a physician's ability to identify patients with lung cancer. The sensor has a reported accuracy of approximately 75%, according to a previous study that Dr. Mazzone led (J Thorac Oncol. 2012;7:137-142

). He noted that "we could improve the accuracy with models that include breath data and clinical data."

Source: http://www.medscape.com/

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Discovery Could Lead to Saliva Test for Pancreatic Cancer

The disease is typically diagnosed through an invasive and complicated biopsy. But a discovery by researchers at the UCLA School of Dentistry may be one major step toward creating a noninvasive tool that would enable clinicians and oncologists to detect pancreatic cancer through a simple risk assessment test using saliva.
In a study on a tumor-ridden mouse model, the UCLA researchers were able to definitively validate that pancreatic cancer biomarkers reside in saliva. The team was led by Dr. David Wong, the dentistry school's associate dean of research and the Felix and Mildred Yip Endowed Professor in Dentistry. The findings are published in a recent issue of the peer-reviewed Journal of Biological Chemistry.

Source: http://www.technologynetworks.com/

Retinitis Pigmentosa Identified by Simple Blood or Urine Test

Research led by physician-scientists at Bascom Palmer Eye Institute of the University of Miami Miller School of Medicine has produced a breakthrough discovery in diagnosing retinitis pigmentosa, a blinding disease that affects about 1 in 4,000 people in the United States.
"It is our vision that every patient who is affected with an inherited eye disease like RP should have access to a clinician who is knowledgeable about the diseases, as well as to affordable diagnostic testing and counseling," said Lam, director of Bascom Palmer's hereditary eye disease center. "This diagnostic test is a powerful tool that will help in developing treatments for RP caused by DHDDS mutations."
Results of this research are published in a paper titled "Aberrant dolichol chain lengths as biomarkers for retinitis pigmentosa caused by impaired dolichol metabolism

" in the Journal of Lipid Research.

Source: http://www.medicalnewstoday.com/

Study Suggests Blood Expression Signatures Can Detect TB

A blood-based gene expression signature is showing promise for detecting active tuberculosis in blood samples from individuals with or without concurrent HIV infections, according to new research.
As reported

in PLOS Medicine, an international team led by investigators in the UK, South Africa, and Australia did a case-control study involving hundreds of individuals from South Africa and Malawi to assess the potential of diagnosing active TB with the help of blood gene expression profiles.
Using expression patterns in the blood of HIV-infected or uninfected individuals with latent TB, active TB, or other diseases, the team developed a so-called "disease risk score," or DRS, classifier. That classifier proved useful for distinguishing active TB from latent forms of the disease and from other diseases with similar symptoms.

Source: http://www.genomeweb.com/

Blood Test for Irritable Bowel Syndrome in the Works

A blood test for antibodies that target the vinculin protein could be used to determine if a condition is related to irritable bowel syndrome (IBS), researchers report. If confirmed, it would be the first serum-based diagnostic test for IBS. "IBS has suffered from a diagnosis-of-exclusion approach, and has limited clinical criteria," said Mark Pimentel, MD, from the Cedars-Sinai Medical Center in Los Angeles.
That limitation prompted Dr. Pimentel and his team to search for alternative diagnostics. He presented the research here at the American College of Gastroenterology 2013 Annual Scientific Meeting.

Source: http://www.medscape.com/

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Detecting BRCA1 and BRCA2 Mutations Via New, Clinically Validated Diagnostic Test

The recognition of a causal link between mutations in BRCA1 and BRCA2 genes and increased risk of developing breast and ovarian cancer has intensified the demand for genetic testing. Identifying mutations in these large genes by conventional methods can be time consuming and costly. A report in the November issue of the Journal of Molecular Diagnostics describes a new technique using second-generation sequencing technology that is as sensitive as the standard methodology but has the potential to improve the efficiency and productivity of genetic testing laboratories.
The investigators warn that as more women undergo genetic testing, there is increased likelihood of finding variants of unknown significance or incidental discoveries. They caution that interpretation of these variants can be difficult and time consuming, and procedures should be developed for reporting these results to physicians and patients.

Source: http://www.medicalnewstoday.com/

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Quest to Offer Genetic Test for Breast Cancer Risk

Quest Diagnostics Inc on Tuesday became the largest U.S. company to start offering gene-based tests for inherited forms of breast cancer since the U.S. Supreme Court ended Myriad Genetics Inc's monopoly on the tests for specific gene mutations. Quest, the largest U.S. medical testing company by revenue, said its BRCAvantage tests will search for mutations in the BRCA1 and BRCA2 genes, which dramatically increase a woman's risk of developing breast and ovarian cancers. Quest has more than 2,100 centers in the United States at which patients can submit blood samples for genetic testing. The cost of the test is about $2,500, a drop from the $3,000 to $4,000 Myriad had charged for its tests.

Source: http://www.cnbc.com/

Myriad Sues Quest Over Cancer Gene Testing

As expected, Myriad Genetics filed a lawsuit alleging that Quest Diagnostics' recent entry into the BRCA gene testing market for breast and ovarian cancers violates Myriad's patents.
The lawsuit, filed Oct. 22 in U.S. District Court for the District of Utah, came one week after Quest, one of the largest clinical laboratories in the U.S., announced plans to start selling tests for the BRCA genes. This is the third patent infringement lawsuit that Myriad has filed since the Supreme Court ruling.

Source: http://www.modernhealthcare.com/

Study Reports Effectiveness of Myriad's myPath Melanoma Test

Myriad Genetics, Inc., has announced that results from a verification study show the Myriad myPath Melanoma test effectively differentiates malignant melanoma from benign skin lesions. The company believes that the clinically actionable information provided by myPath Melanoma will empower healthcare providers with objective data and improve the diagnosis of patients with melanoma. Approximately 14% of skin biopsies, company representatives say, are classified as indeterminate, leading to treatment dilemmas; it is hoped the new test will help pathologists confidently determine whether cells are benign or malignant.

Source: http://www.mlo-online.com/

Could Optical Metabolic Imaging Be More Accurate Than FDG-PET?

A new imaging technique called optical metabolic imaging may be able to identify subtypes of cancer and also measure how tumors respond to drug treatments, according to a new study published in Cancer Research. Researchers from Vanderbilt University in Tennessee used a custom-built, multiphoton microscope alongside a titanium laser to study whether metabolic activity in certain cancers could be visualized. Cell metabolism is a good way to measure how well anti-cancer drugs are working, since cancerous cells consume more sugar for energy than normal cells.

Source: http://www.dotmed.com/

Philips Receives FDA Clearance for Digital Manual Read of HER2 Pathology Slides

Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in healthcare and digital pathology, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market its Her2/neu IHC Digital Manual Read product in the US.
'Clinical pathologists will now have direct access to the digitally stored Her2/neu IHC images to help them in the detection and semi-quantitative measurement of immunohistochemically (IHC) stained breast cancer tissue on their computer monitor.'

Source: http://www.pharmacychoice.com/

Hematology Workflow—Changing How We Think

A key motivator in labs these days is improving hematology workflow to reduce turnaround time (TAT). Efficient use of labor and financial resources, while balancing the need to improve quality has become the associated conundrum with TAT.
It is important for labs to understand workflow of specimens in their operations. Workflow is really a three dimensional problem in most labs. Not only does the lab need to understand two dimensional spaghetti diagrams, showing how tubes and techs are moving around, they need to add the third dimension of boluses of workload with service level demands.
Commercial labs have the advantage of maximizing their capacity by smoothing the boluses due to extremely high volumes and a larger production window measured in 8-10 hour windows vs. 15-20 minutes in the hospital laboratory. The true challenge for the hospital laboratory manager is to increase productivity while meeting service level demands. While manufacturers claim to improve workflow, staff resistance to change often makes the decision of hematology automation very difficult.

Source: http://laboratory-manager.advanceweb.com/

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Gravity Assisted Membrane Filter Separates Plasma From Whole Blood

Separating plasma from whole blood is an important step in measuring viral loads when monitoring infected patients. If you don’t have a centrifuge on hand, this continues to be a slow process that allows for only small samples to be rapidly analyzed, and so not very useful in mobile applications and in remote environments. The other option, membranes that filter objects within certain sizes tend to clog up, so researchers at University of Pennsylvania developed a new filter mechanism that uses gravity to continuously clean the filter and allow for larger blood samples to be separated.

Source: http://www.medgadget.com/

[CLSI] President’s Message, October 2013

Two years ago this month, CLSI published EP23-A™—Laboratory Quality Control Based on Risk Management; Approved Guideline. Last month, the Centers for Medicare & Medicaid Services (CMS) recognized the importance of the main concept of EP23-A—establishing and maintaining an individualized quality control plan (IQCP)—under the new Clinical Laboratory Improvement Amendments (CLIA) Interpretive Guidelines. In the past two years, CLSI has worked hard to make sure all laboratories are ready to implement their own IQCP through the use of the EP23-A document

, as well as its companion workbook

and worksheet

, which are all available in our online shop. The new CLIA guidelines go into effect as of January 1, 2014. You and your laboratory will need to make changes to the way you perform QC testing.

Source: http://www.clsi.org/

On Cuts and Consequences, Pathologists Make Their Case

CMS proposal 1600-P, a rule that would cut payments to physicians by changing the current fee schedule used to reimburse them for their services, has galvanized physicians around the nation and across disciplines. The CAP analyzed the implications of the CMS’ proposed rule for several months. According to the analysis, the rule, as drafted, would inflict drastic cuts to 39 of the most common pathology services used to diagnose tissue biopsies.
Since the CMS introduced in July its revisions to the proposed 2014 Medicare physician fee schedule, it has received a deluge of comments from stakeholders. It is expected to issue its final rule by Nov. 1. “CMS is receiving tremendous pushback on the proposed rule, with 10,220 comments posted on the rule to date,” says John Scott, CAP vice president of advocacy.
CAP members say that the damage the proposed CMS rule would inflict isn’t hypothetical. They know this because the pathology community is still reeling from cuts that took place when the CMS lowered the technical component of surgical pathology code 88305 by 52 percent on Jan. 1. The change altered the global payment for code 88305, which had been projected to decrease by 33 percent as a result of the revaluation.

Source: http://digital.olivesoftware.com/

Medicare Payment Rules Likely to Be Delayed

Medicare physician payment rules expected out by Nov. 1 are likely to be delayed until later in the month, says the Centers for Medicare and Medicaid Services (CMS). In a memorandum to providers, Robert Fritter, director of CMS’s Division of Provider Relations and Outreach, said that although the agency still is assessing the impact of the partial government shutdown on regulatory work, the final rules will be issued by Nov. 27, “generally to be effective on Jan. 1, 2014.”

Source: http://g2intelligence.com/

Sutter to Go Live With ICD-10 Early

While many in the industry are nervous about complying with ICD-10 by the mandated deadline next October, Sutter Health is planning to flip that switch months ahead of time. “Our go-live date will be May 31, 2014,” said Danielle Reno, ICD-10 program director for the health system during a session here at the AHIMA Convention. “We won’t be submitting claims to payers in ICD-10 but we will turn it on and physicians will be able to use it.” Since Sutter has some 5,200 doctors, its road to ICD-10 was paved via physician engagement.
While Sutter is certainly on the leading edge, 3M Health Information Services vice president JaeLynn Williams said in an interview with Government Health IT at the conference that she expects many large health networks to proceed in a similar fashion.

Source: http://www.govhealthit.com/

ACIP OKs 2014 Adult Immunization Schedule With Changes

The Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted unanimously to approve the 2014 adult immunization schedule today.
The vaccine schedule will be revised based on recommendations from today's meeting and will be reviewed on October 28 by the American Academy of Family Physicians, the American College of Physicians, the American Congress of Obstetricians and Gynecologists, and the American College of Nurse Midwives. It will then be submitted to CDC's Morbidity and Mortality Weekly Report (MMWR) on December 2, 2013, and published in the Annals of Internal Medicine and MMWR in early February 2014.
More than 1 member discussed the possibility of making this information available electronically so that it would be more accessible to those who use computers, tablets, and smart phones — although it was agreed that the guidelines need to be available on paper as well.

Source: http://www.medscape.com/

ACIP OKs Meningitis Vaccine (Menveo) for High-Risk Infants

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) voted today to recommend (13 yes, 1 no, 1 abstain) the meningococcal conjugate vaccine MenACWY-CRM (Menveo, Novartis Vaccines) for use in infants and young toddlers who are at increased risk for meningococcal disease. That group includes children aged 2 through 23 months with complement deficiencies or asplenia, those living in areas experiencing outbreaks, and those traveling to or living in areas with high rates of meningococcal disease, including sub-Saharan Africa or Mecca.
The advisory committee develops written recommendations for use of vaccines that are licensed in the United States, taking into consideration age for vaccine administration, number of doses and dosing interval, safety issues, and precaution contraindications.

Source: http://www.medscape.com/

Joint Commission Calls for Hospitals to Address Problem of Objects Left in Surgical Patients

The Joint Commission said hospitals and ambulatory-care centers must improve their counting procedures and other safeguards to reduce the number of objects left inside patients after a wound closure. The costs from the errors—including unreimbursed Medicare payments, plus legal and surgery fees—could range from $166,000 to more than $200,000 per incident. About 95% of the 772 cases of unintended retention of foreign objects, or URFO, logged between 2005 and 2012 resulted in extended hospitals stays or additional care, according to the alert. Those statistics came from volunteer reporting, and officials said the actual number of incidents are probably higher.
The Joint Commission urged hospitals to better educate staff about policies and to develop clear policies to keep track of and count surgical objects that could be left in patients.

Source: http://www.modernhealthcare.com/

As Bacteria Become Increasingly Resistant, New More Effective Antimicrobials Might Rise From Old

By tinkering with their chemical structures, researchers at the University of California, San Diego School of Medicine have essentially re-invented a class of popular antimicrobial drugs, restoring and in some cases, expanding or improving, their effectiveness against drug-resistant pathogens in animal models.
Writing in the Early Edition of PNAS, Lars Eckmann, MD, professor of medicine, and colleagues describe creating more than 650 new compounds by slightly altering structural elements of metronidazole and other 5-nitromidazoles (5-NI), a half-century-old class of antimicrobial drugs used to combat everything from an ulcer-causing stomach bacterium to a gut-churning protozoan found in contaminated water.
The challenge now is to re-new interest and investment in the amended drugs. Eckmann would like to further refine them in preparation for eventual human clinical trials. It will be an uphill struggle, he said. While the WHO has classified metronidazole as an "essential medicine," it's no guarantee of a future, lucrative market for any new and approved drugs.

Source: http://www.medicalnewstoday.com/

Rising Drug Resistance Threatens Global Progress Against TB

In its annual TB report, the Geneva-based World Health Organization (WHO) said the world is on track to meet U.N. goals for 2015 of reversing TB incidence and cutting the death rate by 50 percent compared to 1990. Yet around 3 million people with TB are being missed by health systems, and "superbug" drug-resistant strains of the bacterial infection are putting progress at risk.
"Far too many people are still missing out on care and are suffering as a result," Mario Raviglione, the WHO's director of the Global TB Program, told reporters in London.
The U.N. health agency estimates that 450,000 people fell ill with MDR-TB in 2012 alone, with China, India and Russia worst affected, followed by another 24 other countries. The WHO's report is based on data from 197 countries and territories that together have more than 99 percent of the world's TB cases.

Source: http://www.reuters.com/

Scientists Identify Genetic Errors in 12 Major Cancer Types

Examining 12 major types of cancer, scientists at Washington University School of Medicine in St. Louis have identified 127 repeatedly mutated genes that appear to drive the development and progression of a range of tumors in the body. The discovery sets the stage for devising new diagnostic tools and more personalized cancer treatments. The research, published Oct. 17 in Nature, shows that some of the same genes commonly mutated in certain cancers also occur in seemingly unrelated tumors. For example, a gene mutated in 25 percent of leukemia cases in the study also was found in tumors of the breast, rectum, head and neck, kidney, lung, ovary and uterus.
"This is just the beginning," said senior author Li Ding, PhD, of The Genome Institute at Washington University. "Many oncologists and scientists have wondered whether it's possible to come up with a complete list of cancer genes responsible for all human cancers. I think we're getting closer to that."

Source: http://www.medicalnewstoday.com/

NIH to Fund Nutrigenetics, Nutrigenomics Collaborative Studies

The National Institutes of Health plans to fund research that will use a range of omics technologies to better understand how nutrition affects human health and disease at the genetic and genomic levels. There is growing enthusiasm for the notion that new omics tools and methods will offer new insights into human nutrition research, NIH said.
The new studies, which will be supported by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Cancer Institute, and the Office of Dietary Supplements, will seek to use those approaches to better understand how nutrient and dietary constituents affect metabolism, and to derive mechanistic information about the roles nutrients play in health and disease.

Source: http://www.genomeweb.com/

FDA Must Find Regulatory Balance for Probiotics

"The U.S. Food and Drug Administration (FDA) has no definition of probiotics and regulates them based on whether they fall into one of the existing regulated product categories," says Hoffmann, who along with faculty members from the University of Maryland School of Medicine's Institute for Genomics Sciences, the University of Maryland School of Pharmacy and the University of Maryland Carey School of Law, investigated how probiotics are being regulated.
The coauthors brought together a working group of scientists conducting microbiome and probiotics research, legal academics, food and drug law attorneys, government representatives, bioethicists and consumer advocates to examine the current regulatory structure to determine if it adequately accounts for the risks of probiotics as well as the accuracy of claims of effectiveness. They also considered whether the regulatory structure is flexible enough to allow for (or at least not discourage) research on new probiotic products that may have therapeutic benefits.
The project was supported by a three-year grant from the National Institutes of Health as part of the Ethical, Legal and Social Issues (ELSI) component to the Human Microbiome Project.

Source: http://www.sciencedaily.com/

Leading Medical Journal Refuses to Publish Studies Backed by Tobacco Firms

Publishers of the British Medical Journal (BMJ) and related publications have joined others in boycotting research funded by the tobacco industry. Last week, the editors of the BMJ, Heart, Thorax, and BMJ Open announced

that the journals will no longer consider for publication any tobacco industry-funded study. This new policy is consistent with that of other journals, including PLoS Medicine, the Journal of Health Psychology and the BMJ’s own Tobacco Control.
“Underlying all the activity of peer review, editing, and publishing is the assumption that medical journals exist for the purpose of advancing knowledge that can be used to promote health and reduce disease,” said BMJ Editor-in-Chief Fiona Godlee in a statement. “The tobacco industry has used research to deliberately produce ignorance and to advance its ultimate goal of selling its deadly products while shoring up its damaged legitimacy.”

Source: http://www.health-e.org.za/

NEJM Calls for Release of Trial Data

The international push to get drug companies to share patient-level data from their clinical trials got another shot in the arm Monday with the publishing of two papers in the New England Journal of Medicine.

For years, pharmaceutical industry reformers have said that drug companies should be required to release individual patient data -- with protections to preserve privacy -- as means to ensure more transparency about the true safety and effectiveness of treatments.
At the same time, they cite research showing that up to half of all clinical trial are not published. Today, two online perspectives in the New England Journal of Medicine added to the chorus of calls for more information sharing as medicine enters the new world of "big data."

Source: http://www.medpagetoday.com/

HPV Strains That Affect Black Women Differ From Those Targeted by Cancer-Preventing Vaccines, Researchers Say

“Screening programs for cervical cancer are known to work well, with around 90 percent of sexually active women getting screened through Pap tests,” said senior author Cathrine Hoyo, associate professor of obstetrics and gynecology at Duke.
“The question is, if screening rates are comparable in African-American and white women, why are the rates of cervical cancer and mortality higher among African-American women when we have a program that works so well?”
Hoyo, a cancer epidemiologist, and her colleagues conduced a small study in Tanzania, the results of which were published in 2011. They found HPV subtypes that were more prevalent in the patient population than those targeted by the vaccine.

Source: http://www.cleveland.com/

Screening Program Fights Cancer in Women

A two-year-old Georgia program has served more than 1,600 women at high risk for developing breast and ovarian cancer. The Genomics Consortium is a partnership between the Georgia Center for Oncology Research and Education (Georgia CORE) and the state Department of Public Health. The project is funded by the CDC to raise awareness about cancer genomics, provide breast cancer screenings and educate health professionals in hopes of reaching high-risk, underserved and low-income populations.
Academic partners, including Georgia State, Emory and Morehouse have provided clinical and scientific expertise in the development of the genomics program.

Source: http://www.georgiahealthnews.com/

When the Word 'Cancer' Corrupts Thought and Action

In recent weeks, there have been new calls for new names for some cancer diagnoses – cancer labels – that change peoples’ lives forever. In the BMJ, Dr. Barry Kramer, director of the National Cancer Institute’s division of cancer prevention, and two colleagues wrote an editorial, “The word ‘cancer’: how language can corrupt thought.

” Excerpt:
“Labeling hurts. Healthy people are quickly converted to cancer patients, and toxic interventions are offered and accepted. …antiquated nomenclature should be revised, reserving ‘cancer’ or ‘carcinoma’ for lesions likely to progress if untreated, and raising thresholds for defining ‘abnormal.’ As Otis Brawley of the American Cancer Society has stated, “We need a 21st-century definition of cancer instead of a 19th-century definition of cancer, which is what we’ve been using.”

Source: http://www.medpagetoday.com/

Extra’ Genetic Info—Too Much, Too Quickly?

The dramatic decreases in the time and cost of DNA sequencing that have made it an increasingly practical clinical tool have also presented lab directors with a dilemma: What should be done with potentially clinically relevant genetic information generated in the course of diagnostic sequencing but not ordered by the physician? To the ACMG, the question was of sufficient magnitude to warrant establishing a standard, uniform policy to provide guidance. Accordingly, it convened a working group, and after 14 months of discussion, debate, analysis, and some external review, recommendations were published in March.
The ACMG recommended that laboratories performing germline exome and genome clinical sequencing also analyze and report on pathogenic mutations in 56 carefully selected additional genes involved in a variety of serious diseases (see “The ACMG list”). The criteria for selection were that the diseases be both highly penetrant and actionable. The recommendations state that these incidental, or secondary, findings should be reported to the ordering physician as a matter of routine, regardless of the age of the patient or the nature of the original diagnostic order.
Laboratories find disease-causing variants in the course of exome and genome analysis, even when not explicitly looking for those variants, and being asked to withhold findings puts labs in a difficult spot, says Heidi Rehm, PhD, director of the Partners Healthcare Laboratory for Molecular Medicine, Cambridge, Mass., and a member of the ACMG working group. “We find that families are asking for these results and are even surprised we would consider not returning them.”
Although the ACMG recommendations do not address financial and reimbursement issues, these will certainly have an impact on the medical community’s ability to carry them out. Physicians worry about the financial burden of genetic counseling , which is not always covered by insurance, and of followup testing and the resulting treatment or surveillance.

Source: http://digital.olivesoftware.com/

Patients Share Tips Online for Managing Diseases

Web communities like Crohnology.com are at the nexus of the "e-patient" movement, which champions patients as full partners in their own medical care, making them participants rather than mere recipients. The thinking is that patients who share information about their health care experiences and engage more fully in understanding their options will receive a higher quality of care.
"The 'e' in e-patient is for engaged patient, empowered patient," said Dr. Larry Chu

, director of Stanford Medicine X

, an initiative that examines medicine and emerging technologies. More informed, vocal patients, he said, are more likely to get what they need.
At present, the number of patients who communicate with each other online about their health is still relatively small. According to recent Pew research, about 24 percent of American adults with a significant health concern reported getting information or support from others with the same health condition.

Source: http://www.sfgate.com/

Big Gaps Found in Hospital Mortality, Complication Rates

For patients, paying attention to hospital ratings can be a matter of life and death, according to a new report published online

today by Healthgrades, a healthcare quality reporting group. These wide divergences emerge in an annual report scrutinizing clinical performance in 31 of the most common procedures and conditions at more than 4500 hospitals. For 19 performance categories such as stroke, colorectal surgery, pancreatitis, pulmonary embolism, and pneumonia, the focus is on mortality rates. Healthgrades analyzed complication rates in the 12 remaining categories, which include hip replacement, spinal fusion, and carotid surgery.
The study, called American Hospital Quality Outcomes 2014: Healthgrades Report to the Nation, is available on the organization's Web site

.

Source: http://www.medscape.com/

With Chip Design Finalized, UK Biobank, Affymetrix Commence 500K-Sample Genotyping Effort

The UK Biobank and Affymetrix recently finished developing an array that will be used to genotype all 500,000 samples in UKBB's biorepository. Affymetrix is also selling the chip to its customers, and has seen "significant" demand for it, according to company representatives. Peter Donnelly, a professor of statistical science at the University of Oxford, provided an overview of the UKBB's chip during an Affymetrix workshop held at the American Society of Human Genetics' annual meeting in Boston last week.
The first 50,000 samples of the large genotyping effort are being run for the purposes of the UK Biobank Lung Exome Variant Evaluation, or BiLEVE project. Funded by the UK Medical Research Council and approved by UKBB, the year-old effort aims to better understand genetic predisposition to lung disease. UKBB's chip also contains more focused content, including variants that have been reported as being associated with certain conditions. "We wanted to do an experiment where we looked at variants in very large sample sizes to see whether ordinary people carry the same variants without necessarily having severe phenotypes as a consequence," Donnelly said.

Source: http://www.genomeweb.com/

Swedish Researchers Ready 'World's Largest Protein Array' for Autoimmunity Screening

Though protein microarrays have arguably lagged nucleic acid arrays in terms of adoption and commercialization, technology development continues apace. According to Peter Nilsson, protein and peptide platform array manager at Sweden's Science for Life Laboratory, or SciLifeLab, it is "no longer early days" for protein array technology, and his lab is in the process of spotting what he believes is the highest-density protein array available to date. Nilsson spoke earlier this month with BioArray News during a visit to SciLifeLab's Stockholm facility. He said at the time that his lab was preparing to produce an array containing about 21,120 proteins spread across 55 separate 384-well plates.
"Microarrays in proteomics have lagged nucleic acid arrays," said Paschke, "And some people need to be educated and convinced of the things that you can do with an array that has 20,000 proteins on it."

Source: http://www.genomeweb.com/

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Food Testing: Labs Test for Pathogens at Different Rates in the U.S. and Europe

Testing in the U.S. varies somewhat from company to company, but it follows similar procedures that were standardized in 2007 with the Leafy Green Marketing Agreement, says Trevor Suslow, food-safety specialist at the University of California, Davis. It involves sampling from a field before or after harvest to assess the risk of a lot. But the situation is different in Europe. While European labs do test for pathogens, it’s not their main concern, says Keith Warriner, a professor of food science at the University of Guelph and program director of the school’s food safety and quality assurance program. “We just look for E. coli and Salmonella, whereas the Europeans are a bit more risk-based,” he says.
Suslow and Warriner both say it’s very difficult to judge whether one system is better than the other since, after all, they are based on very different structures. Europe’s agricultural system consists of a lot of smaller farms and, Suslow says, “The smaller the company, the harder it is economically to factor in the cost of pathogen-testing materials into your program.” But in North America’s favor is “a much better surveillance system,” Warriner says. “And so when outbreaks happen, we’re really on to it.”

Source: http://www.foodsafetynews.com/

Survey: 96% of Canadians Think That Health Care System Should Make Use of Digital Health Tools

Ninety-six per cent of Canadians think it's important that the health care system make use of digital health tools and capabilities, and 89 per cent feel it is important that they personally have full advantage of digital health tools and capabilities, according to a new survey by Harris/Decima, released by Canada Health Infoway (Infoway). Other key findings from the Harris/Decima report include:

86 per cent of Canadians agree that digital health will provide health information to a care team in an emergency situation
86 per cent of Canadians believe it is important that their doctors use electronic medical records
90 per cent of Canadians who access their own health information online describe the experience as positive

Source: http://www.news-medical.net/

Mexico Bans Foster Farms Chicken From Plants Linked to Outbreak

The government of Mexico has banned imports of Foster Farms chicken from the poultry grower’s three central California processing facilities linked to a Salmonella outbreak in the U.S., according to The Oregonian

. This is the first time Mexico has banned meat products from a U.S. facility as a result of a public health alert issued by the U.S. Department of Agriculture’s Food Safety and Inspection Service, according to a source at the agency. Mexico has not banned meat from other Foster Farms plants in California, Oregon and Washington.

Source: http://www.foodsafetynews.com/

Lab Testing: Hunting for Pathogens on Poultry

USDA Food Safety and Inspection Service guidelines require microbiological sampling to monitor raw poultry for harmful pathogenic bacteria such as Salmonella and Campylobacter, but the regulations are not necessarily enforceable because no strains of Salmonella and Campylobacter are classified as adulterants.
This means that most pathogen-testing standards within the poultry industry are written at the company level. Oftentimes, the testing is done so that the processors are able to ensure that their own control systems are working, said Dave Theno, CEO at Gray Dog Partners, who added that the companies that test most aggressively are the ones that achieve the highest levels of microbial control.
No mandates regulate the percentage of birds that must be tested from each production facility. Instead, companies develop their own best practices. A large processing center may typically sample one bird every hour or two, but a large amount of variation exists, Theno said.
Large-scale production facilities typically test products within their own labs, which helps save time, while some smaller producers ship their samples to outside labs. USDA issued a guide

in June that helps provide guidance for selecting a commercial or private lab for microbiological testing.

Source: http://www.foodsafetynews.com/

ASCLS Voice: Going Global

IFBLS is a Professional Organization
Were you aware that ASCLS, the American Society for Clinical Laboratory Science is a member of a federation of international medical laboratory science professional organizations? Much like ASCLS, and other professional organizations, the purpose of IFBLS [International Federation of Biomedical Laboratory Scientists] is to support and promote the profession of Biomedical Laboratory Science, the international title for Medical Laboratory Science. Specifically IFBLS promotes the advancement of our profession by developing and adhering to standards of practice—standards of professional practice based upon scientific foundations such as performing quality control; supports appropriate education and professional development of Biomedical Laboratory Scientists; advocates following a code of ethics; creates opportunities for the exchange of ideas among professionals, and coordinates international partnerships. Excluding the focus upon international partnerships, the purpose of IFBLS is identical to that of ASCLS.

Source: http://laboratory-manager.advanceweb.com/

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Disclaimer- The information provided in this news digest is intended only to be general summary information. It does not represent the official position of the Centers for Disease Control and Prevention and is not intended to take the place of applicable laws or regulations.