viernes, 3 de enero de 2014



Healthcare News

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


January 02, 2014

View Previous Issues - Healthcare News Archive

2013’s Big Advances in Science

Most spectacularly evident in 2013 was how easily new techniques caught fire and spread to labs around the globe. Here are some of the most exciting advances in the life sciences from 2013.
  • What can’t CRISPR do? – Clustered regularly interspaced short palindromic repeats, or CRISPR, is a tool used for genome editing
  • Organoids galore – New types of lab-grown organ buds, also called organoids, popped up in 2013
  • Potent stem cells – The ability to reprogram skin cells to pluripotent stem cells by a simple gene-expression formula opened up a world of new experiments
  • Expanded uses for 3-D printing – 3-D printers can make everything from test tube racks to centrifuges to tonight’s dinner
  • Hydrogel implants – In another brilliant example of manipulating scaffolded cells, researchers developed a hydrogel implant embedded with a fiber optic cable that can direct the activity of cells with light
  • MacGyver-style microfabrication – Not all in scientific progress must involve fancier methods to solving problems
  • The next generation – Up-and-coming in vitro fertilization techniques gave parents in Philadelphia their next generation, a baby boy born in May


Congress Backs Policy Aimed to Cut Down on Unnecessary Imaging Tests

A permanent fix to the unpopular sustainable growth rate formula or "doc fix" is making its way through Congress and physicians might be surprised to find out that a provision tucked away in the proposed law would require them to consult "appropriateness criteria" when referring Medicare patients for advanced imaging tests. The policy, which the American College of Radiology helped lead, is essentially a decision-support tool that will be used by physicians and overseen by the Centers for Medicare and Medicaid Services and the secretary of Health and Human Services. 
"Most providers will consult this and it will guide them," Cynthia Moran, assistant executive director of government relations at ACR, told DOTmed News. The appropriateness criteria, which is evidence-based, will be embedded in an electronic health record and will notify the provider automatically if the ordering test is appropriate or not. Providers can log onto a secure page on CMS' website to consult the criteria as well. 


Certain Circumstances

The US Preventive Services Task Force has updated its recommendations External Web Site Iconfor assessing and testing BRCA1 and BRCA2 mutations for breast and ovarian cancer susceptibility. As the task force's chair, Virginia Moyer, writes in the Annals of Internal MedicineExternal Web Site Icon, routine genetic screening in the absence of family history of the disease is not warranted. 
"We have great hope in the science of genomics to improve screening practices and even prevent some cancers," Moyer said in a statement. "At this point, the evidence shows that most American women will not benefit from genetic counseling or the test for gene mutations in BRCA1 and BRCA2.”


Justice Department Recovers $3.8 Billion From False Claims Act Cases in Fiscal Year 2013; Second Largest Annual Recovery in History Whistleblower Lawsuits Soar to 752

The False Claims Act is the government's primary civil remedy to redress false claims for government funds and property under government contracts, including national security and defense contracts, as well as under government programs as varied as Medicare, veterans benefits, federally insured loans and mortgages, transportation and research grants, agricultural supports, school lunches and disaster assistance. In 1986, Congress strengthened the Act by amending it to increase incentives for whistleblowers to file lawsuits on behalf of the government, which has led to more investigations and greater recoveries.
Some of the largest recoveries this past fiscal year involved allegations of fraud and false claims in the pharmaceutical and medical device industries. Of the $2. 6 billion in federal health care fraud recoveries, $1.8 billion were from alleged false claims for drugs and medical devices under federally insured health programs that, in addition to Medicare and Medicaid, include TRICARE, which provides benefits for military personnel and their families, veterans' health care programs and the Federal Employees Health Benefits Program. The department recovered an additional $443 million for state Medicaid programs.


'Antibacterial' Products are Finally Getting Scrutiny

FDA says claims that popular products fight infection are unproven. A high-profile moveExternal Web Site Icon this week by the U.S. Food and Drug Administration should have come as a shock to consumers who have long used “antibacterial” soaps, lotions and other products to ward off illness. Despite widespread use since the late 1970s, a top FDA official said bluntly on Monday that their added value in fighting infection is unproven as questions mount about potential risks.
Scientists and leading public health officials have urged the agency for years to scrutinize products that commonly contain the chemical triclosan as the active ingredient. Still, the FDA’s proposed regulatory measure to require manufacturers to prove their products work and are safe is welcome even if long overdue. If manufacturers can’t do so, they could be required to reformulate or relabel their products.


The Association for Molecular Pathology Releases Position Statement on LDTs

The Association for Molecular Pathology (AMP) released a special article in the January 2014 issue of the Journal of Molecular Diagnostics titled "Revisiting Oversight and Regulation of Molecular-Based Laboratory-Developed Tests"(LDTs). The article includes an overview of different group's perspectives on LDTs. Approaches of the FDA and AdvaMed are compared to those of ACLA, CAP, and others including an upcoming HHS report on the issue. 
The definition of AMP's new term, Laboratory Developed Procedure is: A professional service that encompasses and integrates the design, development, validation, verification, and quality systems used in laboratory testing and interpretive reporting in the context of clinical care. 


Bill Seeks to Clean Telehealth State Regulations Mess

Telehealth regulations differ in each of the 50 states, inhibiting use of technology to treat patients, say proposed law's sponsors. Representatives Doris Matsui (D-CA) and Bill Johnson (R-OH) have introduced a bill in Congress that creates a federal definition of telehealth and that provides guidance to states on how to regulate this burgeoning field. The Telehealth Modernization Act of 2013 (H.R. 3750) includes the following principles:
  • Informed care: A healthcare professional should have access to and review the medical history of the individual he or she is treating via telehealth.
  • Diagnosis: The health professional should have an interactive conversation with the patient adequate to establish any diagnosis rendered.
  • Documentation: A health professional should document the evaluation and any treatment furnished to the patient, as well as generate a medical record of the encounter.
  • No assurance of outcome: A health professional should make no assurance regarding an outcome, including receiving a prescription.
  • Prescription requirements: Prescriptions provided by the professional should be issued for a legitimate medical purpose only. The prescription should not be a controlled substance and must be filled by a valid dispensing entity.


ObamaCare, Doctor Shortage to Spur $2 Billion Telehealth Market

The business of treating patients via telehealth in the U.S. will dramatically increase to nearly $2 billion in revenue within five years due to a confluence of events in the health care industry from doctor shortages to provider payment changes under the Affordable Care Act. The trend toward telehealth will be driven by employers, private insurers and the Affordable Care Act, which makes doctors and hospitals more accountable by moving medical care providers away from fee-for-service medicine where they are paid based on volume of services to reimbursement based on the value of care they provide. 
“The majority of these patients are diagnosed with cardiovascular diseases, pulmonary diseases and diabetes and most of them are enrolled in post-discharge services of an average of 30-90 days,” said Roeen Roashan, IHS analyst for consumer medical devices and digital health. This will increase the patient volume toward these services to more than 3.2 million patients in 2018 from less than 250,000 this year. Meanwhile, the value of the U.S. telehealth market will reach $1.9 billion in 2018 compared to about $230 million today, IHS’ Roashan said. That’s a cumulative annual growth rate of more than 56 percent.


Elderly Homes Weak Link in Battle Against Superbugs

Antibiotics that are the last line of defense against life-threatening germs spread commonly in hospitals are starting to lose power in Europe, the European Centre for Disease Prevention and Control said last month.  New findings are giving credence to the idea that superbugs, which resist the most powerful antibiotics, thrive just where the frailest people dwell: nursing homes. 
The latest research adds to a growing body of evidence pointing to elderly residences as one of the weak links in the world’s escalating battle against the overuse of antibiotics and the rise of superbugs. The nature of those homes, with their mix of patients moving in and out of hospitals and living for extended periods in close proximity makes them a difficult environment to track and destroy germs. 
Drug resistance has brought the planet to the brink of what World Health Organization Director-General Margaret Chan in September described as “a post-antibiotic era, where common infections will once again kill.” 


Genetic Differences Discovered Between 'Identical' Twins

Technically, the Eurofins scientists applied Eurofins' ultra-deep next generation sequencing and associated bioinformatics techniques. They sequenced DNA from sperm samples of two twins and from a blood sample of the child of one twin. Bioinformatics analysis revealed five mutations, so called Single Nucleotide Polymorphisms (SNPs) present in the twin father and the child, but not in the twin uncle. The SNPs were confirmed by classical Sanger sequencing. The results give experimental evidence for the hypothesis that rare mutations will occur early after or before the human blastocyst has split into two, the origin of twins, and that such mutations will be carried on into somatic tissue and the germ line. 
The genetic differences found and the method used provide a solution to solve forensic and paternity cases involving monozygotic twins as originator of DNA traces in crime, or as alleged fathers. Eurofins is the first to offer such a test.


Genetic Puzzle Piece for Blood Cancers Found

Two research groups have filled in another piece of the pathogenetic puzzle of myeloproliferative neoplasms. The new piece is the gene for calreticulin (CALR), the investigators reported here at the annual meeting of the American Society of Hematology and online in the New England Journal of Medicine
The finding should help in the diagnosis of myeloproliferative neoplasms, and especially essential thrombocythemia and primary myelofibrosis, according to researchers led by Robert Kralovics, PhD, of the CeMM Research Center for Molecular Medicine of the Austrian Academy of Sciences in Vienna, and Anthony Green, FRCPath, of the Cambridge Institute for Medical Research in Cambridge, England. 


Poor Handwriting Leads to Patient's Death

While visiting her in the hospital, Dr. F began writing a prescription for 10 mmol of potassium for the patient. He was interrupted while he was writing, and when he went back to it afterwards, he rethought the dosage and decided to make it 20 mmol instead.  However, rather than start with a fresh prescription, or cross out what was already written, Dr. F attempted to write a number “2” over the “1.” After he left the hospital, the nurse and pharmacist misread the prescription, believing that it read 120 mmol rather than 20. The prescription was filled for 120 mmol of potassium. Within 12 hours, Mrs. D was dead. 
“Even if I was a little sloppy in writing the script,” he told his defense attorney, “there were at least two other healthcare professionals who should have caught it before it ever reached the patient. And if they couldn't read what I'd written, why didn't they call me?” The defense attorney reluctantly agreed, and the case proceeded to trial. 


'Stop Scaring Patients': How Esophageal Cancer Evolves

A new study demonstrates how esophageal adenocarcinoma evolves during a 4-year period as a dynamic, stochastic process of punctuated equilibrium followed by catastrophic genomic doubling. The study was published online Adobe PDF fileExternal Web Site Icon November 19 in Cancer Prevention Research.
Until recently, scientists have believed that neoplastic evolution is a gradual and linear process. However, screening strategies built on this flawed paradigm have grossly failed in their efforts at early cancer detection, lead investigator Brian J. Reid, MD, from the Division of Human Biology and the Division of Public Health Sciences at the Fred Hutchinson Cancer Research Center in Seattle, Washington, told Medscape Medical News.


Novel Agent Set for Unique Clinical Test in Inflammatory Breast Cancer

A drug now used to treat a type of lymphoma has shown surprising benefit in preclinical studies of inflammatory breast cancer, according to a researcher at Thomas Jefferson University's Kimmel Cancer Center.  The finding, published in a recent issue of the Journal of Experimental Therapeutics and Oncology, has led to development of a phase 1/2 clinical trial at Kimmel Cancer Center to test the agent, Romidepsin (Istodax™), in combination with nab-paclitaxel (Abraxane™) chemotherapy for advanced inflammatory breast cancer (IBC). 
One of the reasons for the lethality of inflammatory breast cancer is that early in the disease onset it produces emboli - small balls of cancer cells - which spread through the lymph system causing the typical breast swelling. These aggregates of cancer cells are resistant to chemotherapy, radiation, and are believed to be responsible for rapid metastasis, Dr. Cristofanilli says. Experiments in laboratory cells and in mice models of inflammatory breast cancer demonstrates that Romidepsin is able to break the bonds that bind the cancer cells together, which then allows chemotherapy to effectively target single cancer cells, he says. 


10-Gene Biomarker May Aid Cancer Treatments

Researchers with the Women’s Cancer Program at Cedars-Sinai’s Samuel Oschin Comprehensive Cancer Institute in Los Angeles have identified a series of 10 genes that may reflect improved survival outcomes. The research, led by Dr. Dong-Joo (Ellen) Cheon, found that the 10-gene biomarker panel may identify the aggressiveness of a patient’s disease, help predict survival outcomes and result in novel therapeutic strategies tailored to patients with the most adverse survival outcomes, according to a recent release from Cedars-Sinai.


Surgical Robots Get Same Results at Higher Cost

In a study of national data on colon surgery, Johns Hopkins researchers found that while patients who undergo either minimally invasive laparoscopic surgery or the high-tech robotic approach have similar outcomes, robotic surgery is significantly more expensive. The findings provide a counterpoint to the aggressive advertising used by some hospitals to tout benefits of the pricey new gadget, even before research has been done to learn whether robotic surgery is actually better for patients.
“The true test of something new in medicine should be: Is it better? Is it safer? Does it save money? If not, then we probably shouldn’t be using it,” says Nita Ahuja, an associate professor of surgery and oncology at the Johns Hopkins Univ. School of Medicine and leader of the study published online in JAMA SurgeryExternal Web Site Icon. “What we have found is that the robot is no better than laparoscopy and it costs more. It has no benefit.”


Fewer California High School Students Exposed to Tuberculosis Than Expected

More than 100 people who attend or work at a southern California high school will be treated with antibiotics after being exposed to tuberculosis, a spokesman for the Riverside County Health Department said Monday.  Of the 1,471 students and staff at Indio High School, 126 -- or 8.6% -- were exposed to tuberculosis, but only one student actually has the illness. The health department said the students exposed had a 10% chance of getting tuberculosis during their lives if left untreated.  According to the Centers for Disease Control and Prevention, approximately one-third of the world's 6 billion people are infected with TB. 


HIV Mechanism: 'Suicide, not Murder'

In uncontrolled HIV infection, an over-the-top immune response causes much of the damage that leads to AIDS, researchers are reporting. The process is "much more of a cellular suicide than a viral murder," according to Warner Greene, MD, PhD, of the Gladstone Institutes at the University of California San Francisco. In papers in Nature and Science, Greene and colleagues outline–for the first time–how resting CD4-positive T cells die in response to HIV infection. It's a "very new perspective," Greene told MedPage Today, and one that could very quickly lead to new therapeutic and perhaps even curative approaches.
The findings are a significant advance in the understanding of HIV pathophysiology, commented Demetre Daskalakis, MD, of Mount Sinai Hospital in New York City. Even more than 30 years into the HIV/AIDS pandemic, he told MedPage Today, "it's remarkable that a lot is not known about how the very important cells in the immune system are actually depleted…. Understanding HIV biologically is how you translate that to clinical innovation," he said.


Microbiome Adapts to Diet Change in a Day

The human gut microbiome is well known to adapt during the long term to a changing diet, but a study published onlineExternal Web Site Icon December 11 in Nature shows that this adaptation can happen in a day. Chronic illnesses related to nutrition and digestion, such as obesity and inflammatory bowel disease (IBD), may arise at least in part from microbiome changes that parallel the fatty and sugary diets that many Westerners follow.
"Together, these findings are consistent with the hypothesis that diet-induced changes to the gut microbiota may contribute to the development of [IBD]," the researchers conclude.


Genotyping Strategy Could Boost Celiac Screening Efficacy

Genotyping for human leukocyte antigen (HLA) followed by biopsy is a sensitive strategy for detecting histopathologic lesions in the close relatives of people with celiac disease (CD), research indicates. Around half of individuals screened with this approach would be expected to show some form of enteropathy, report Santiago Vivas (University Hospital of León, Spain) and co-workers in the European Journal of Gastroenterology and Hepatology.
Noting that this approach was more than three-fold more sensitive than serology-based screening, the authors conclude: “[A] diagnostic strategy on the basis of HLA-DQ genotyping, followed by a duodenal biopsy in positive relatives, may be an alternative to detect [first-degree relatives] with alterations in the duodenal mucosa irrespective of the serological test results.”


Scientists Start to Unpick Narcolepsy Link to Flu Vaccine

Results from U.S. researchers showed that narcolepsy, characterized by sudden sleepiness and muscle weakness, can be set off by an immune response to a portion of a protein from the H1N1 virus that is very similar to a portion of the wake-promoting neuropeptide hypocretin, which is a key player in narcolepsy.
Emmanuel Mignot, a narcolepsy researcher and director of the Stanford Center for Sleep Sciences and Medicine who has been funded by GSK to look deeper into the link, said the relationship between H1N1 infection, vaccination and narcolepsy gave his team "some very interesting insight into possible causes of the condition."
Mignot said the findings, published December 18 in the journal Science Translational Medicine, could pave the way to a new blood test to diagnose narcolepsy. 


Fighting Flu

Researchers link host glucose metabolism with severity of influenza infection.
Vast amounts of time and research dollars go into studying how the quickly mutating influenza virus works, anticipating which strains will be most active each year, and changing the flu vaccine accordingly. Researchers from the University of North Carolina, Greensboro, recently approached the problem from a different perspective by looking at the host’s response to the virus. Amy Adamson and Hinissan Kohio showed that flu infection is linked to glucose metabolism in mammalian cells. They presented their work today (December 15) in a poster session at the American Society for Cell Biology meeting in New Orleans, Louisiana, and in a paper published in September in VirologyExternal Web Site Icon.


Maternal Blood Test May Reveal Severity of Fetal Hypoxia

A maternal blood test measuring messenger RNA (mRNA) expression of hypoxia-induced genes may provide a noninvasive method to monitor the severity of fetal hypoxia/acidemia during pregnancy, according to research published onlineExternal Web Site Icon December 9 in BMC Medicine.
Clare Whitehead, MBChB, from the Translational Obstetrics Group, Department of Obstetrics and Gynaecology, University of Melbourne, Mercy Hospital for Women, Victoria, Australia, and colleagues correlated mRNA expression of hypoxia-related genes in maternal blood to lactate levels in umbilical arterial cord blood in 2 studies: one that sampled maternal blood during induced labor as a measure of acute hypoxia, and a second that sampled maternal blood during pregnancy among women with severe fetal growth restriction (FGR) as a measure of chronic hypoxia.


CytoGenX Debuts Chromosomal Microarray Analysis Services for Prenatal, Pediatric, Cancer Testing

CytoGenX, a Stony Brook, NY-based medical genetic testing services company, recently introduced chromosomal microarray analysis [CMA] for a number of different indications. The new offering, called the Assure platform, relies on a high-density chip to identify disease-causing genetic alterations in prenatal and pediatric diseases as well as cancer and infertility. 
In a statement last week, CytoGenX said that new guidelines from professional organizations encouraged the company to offer the new array-based service. Specifically, it referred to recent American College of Obstetrics and Gynecologists guidelines that recommend the use of CMAExternal Web Site Icon to all patients undergoing an amniocentesis or chorionic villus sampling and that the tests should not be restricted to women age 35 and older. CytoGenX also noted that the American College of Medical Genetics has recommended the use of CMA as a first-tier diagnostic test for both postnatal and prenatal samples, and as a complementary approach in diagnosing neoplastic disorders.


New Diagnostic Test can Detect Chlamydia trachomatis in Less Than 20 Minutes

Researchers have developed a new assay for rapid and sensitive detection of Chlamydia trachomatis, the most common sexually transmitted infection (STI) in humans. This procedure takes less than 20 minutes and can be easily performed at the point of care (POC) during the patient's visit, reports The Journal of Molecular Diagnostics.
The assay uses recombinase polymerase amplification (RPA), a nucleic acid amplification technique (NAAT), to detect C. trachomatis directly from urine samples. Because the assay's novel approach does not require the purification of total DNA from the urine sample, the need for specialized equipment is eliminated. It is relatively simple to perform and could therefore be applied in numerous POC settings.


Some Genetic Genealogists Concerned as Consumer Genomics Firms Move to New Chip Designs

Representatives for Family Tree DNA and told BioArray News recently that the content on their newer chips would not differ significantly from the previous array designs. But 23andMe's new chip is a different case, as the company's new array contains just over 602,000 variants, more than 300,000 fewer markers than the 967,000 variants contained on its previous generation array.
"There is no doubt that decreasing the number of SNPs from almost one million down to just over 600,000 will negatively impact the ability to utilize the data effectively with third party tools, which are extremely important to our community," said CeCe Moore, a professional genetic genealogist who works as a consultant to the programs Finding Your Roots with Henry Louis Gates, Jr. andGenealogy Roadshow.


Caris Gets Tumour Profiling Industry’s First ISO 15189 Medical Laboratory Accreditation

Caris Life Sciences, …has received molecular profiling industry’s first-ever accreditation for its tumour profiling laboratory located in Phoenix, Arizona to the International Standards Organization (ISO) 15189 “Medical laboratories – Requirements for quality and competence,” accredited by the American Association for Laboratory Accreditation (A2LA).
Caris’ laboratory performs the genomic testing associated with Caris Molecular Intelligence, the company’s comprehensive tumour profiling service, … with 50,000-plus cancer patients profiled across the world to date. …Caris has also earned accreditation from Clinical Laboratory Improvement Amendments (CLIA), as well as an extensive list of certifications from the state of New York. The company also operates one of the few commercial biorepositories with College of American Pathologists (CAP) accreditation.


Lab Produces Quality Control Materials for Forensic, Clinical Testing

The idea of filling a void in forensic and clinical lab testing circles was born 40 years ago in 1973 of Larry and Judy Plutchak when they launched UTAK Laboratories of Valencia to supply much need quality control materials – blood, urine and body fluid materials – for test verifications in labs across the country.
Forensic and clinical labs run tests today looking for scores of possible scenarios – did a person die of drug or alcohol poisoning; is a patient vitamin-D deficient; or is a psychotropic medication level too high or low in one’s body for a person to function properly? Getting the right test result is really important, Plutchak said. Whether its blood, urine or body fluids being tested, a lab needs comparative test materials to know if their equipment is accurately testing for a lethal amount of alcohol or drugs; or if a living person is being affected by any number of natural, medication or environmental factors – like metals and leads.


Hospital Pushes for Quiet on the Set

Voices are lowered, lights are turned down and nurses remind themselves to step softly. “We try not to schedule any tests during that time, too,” said Gladys Garcia, manager of the ICU. The efforts in St. Joseph's birthing unit and ICU are just part of a larger multi-unit initiative undertaken nearly two years ago by the 301-bed hospital to reduce unnecessary noise, a vexing problem made worse by increasingly complex technology. 
Mandated by the Patient Protection and Affordable Care ActExternal Web Site Icon, value-based purchasing ties a portion of hospitals' base DRG payments to performance on a set of measures of clinical quality and patient experience, including hospital noise. The lost sleep and stress associated with hospital noise may also lead to worse health outcomes, according to recent research. A January 2012 study by University of Chicago researchers found that hospital noise levels often exceeded World Health Organization recommendations. And a June 2012 study by Harvard University researchers found that patients' heart rates increased after noise-related sleep disruptions. 


Hospital Lab Undergoes CMS Resurvey

A team from the U.S. Centers for Medicare and Medicaid Services was once again on island [Saipan, Mariana Islands] last Thursday, this time to resurvey the public hospital’s laboratory unit. Commonwealth Healthcare Corp. interim CEO Esther Muña confirmed this with the Saipan Tribune and she expressed optimism that the final results will be positive. Muña said the latest CLIA survey would still need to be reviewed by the CMS Office in Region 9. However, she disclosed that the survey showed that they meet most of the conditions of maintaining CLIA certification. Noting the great strides made at the hospital’s lab in the past year, Muña commended the cooperation and collaboration demonstrated by certain individuals and groups.
“We had an opportunity over the past year to improve our services in the laboratory as well as throughout the hospital….,” added Muña. 


Microbiologists at Weill Cornell Use Next-Generation Gene Sequencing to Map the Microbiome of New York City Subways

Pathologists and clinical laboratory managers can expect environmental microbiome detection and monitoring to play an increasingly important role in disease diagnosis, treatment and prevention. For decades, microbiologists and clinical laboratory professionals have prowled the corridors of hospitals to swab physicians’ neckties, the hands of nurses and staff, and various surfaces. These swabs were then cultured to demonstrate how easily infectious microbes can be transmitted in everyday activities.
Now researchers, including microbiologists, are combing the New York City subway system to swab surfaces, collect specimens, and create a map of the urban microbiome. Researchers at Weill Cornell Medical College in New York City want to use the microbiome to pioneer a new method for city-level pathogen monitoring.

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.

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