A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
January 22, 2015
- Progress Being Made in Infection Control in U.S. Hospitals; Continued Improvements Needed
- Mayo Fights Stricter Oversight of Lab Tests
- Public Workshop - Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015
- Expansion Microscopy Stretches Limits of Conventional Microscopes
- Newer Heart Attack Test 'could save women's lives'
- Tattoo-like Sensor Can Detect Glucose Levels Without Painful Finger Prick
- Could Vitamin A Deficiency be a Cause of Type 2 Diabetes?
- OHSU Star Researcher Louis Picker Unravels Another Mystery in Quest for HIV Cure
- How Blood Stem Cells Take Root in the Body
- Oral HIV Vaccine Undergoing Testing
- Birth Defects Drop 35% due to Adding Folic Acid to Flour
- OpenFDA: Making Federal Public Health Data Sets Accessible
- 10 Strategies for Protecting Patient Data in 2015
View Previous Issues - Healthcare News Archive
Progress Being Made in Infection Control in U.S. Hospitals; Continued Improvements Needed
Progress has been made in the effort to eliminate infections that commonly threaten hospital patients, including a 46 percent decrease in central line-associated bloodstream infections (CLABSI) between 2008 and 2013, according to a report released by the Centers for Disease Control and Prevention. However, additional work is needed to continue to improve patient safety. CDC’s Healthcare-Associated Infections (HAI) progress report is a snapshot of how each state and the country are doing in eliminating six infection types that hospitals are required to report to CDC. For the first time, this year’s HAI progress report includes state-specific data about hospital lab-identified methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infections and Clostridium difficile (C. difficile) infections (deadly diarrhea).
Mayo Fights Stricter Oversight of Lab Tests
Proposed federal rules to require new government approval of certain tests developed in medical schools and private business laboratories have drawn cries of protest from the Mayo Clinic. The proposed rules would for the first time make labs designing the tests prove their effectiveness to the U.S. Food and Drug Administration (FDA). Test developers also would have to formally report to the government problems that occur with the tests after they become available. Mayo says it already goes through a certification process with other federal agencies and monitors its so-called adverse events. The clinic recently sent the chairman of its laboratory medicine and pathology department to Washington to testify against the rules as the government considers tweaking them. “These rules have the potential to get in the way of effective patient care and really disrupt the whole patient-physician-laboratory relationship,” Dr. Curtis Hanson told the Star Tribune after his testimony to the FDA. At stake for Mayo is a major portion of its lucrative laboratory testing service, which is part of a national $65 billion-a-year industry that is among the fastest growing sectors of U.S. medical technology. Mayo offers 1,600 lab-developed tests among an array of 3,500 tests.
Public Workshop - Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests Public Workshop, February 20, 2015
The Food and Drug Administration (FDA) is announcing a public Workshop entitled: “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” The purpose of this workshop is to discuss and receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology.
Genomic Sequencing’s Value Challenged in Stanford Study
The environment may be a much bigger driver of human health than genetics, which raises questions about the value of genomic sequencing and the push toward personalized medicine, says a team of Stanford scientists studying the immune system. “Genomics technology has advanced so much that we’re seeing an explosion in sequencing and analyzing this and that. Everything starts to look like genetics. And yet, it isn’t, really,” said Mark Davis, lead author of the study and director of Stanford’s Institute for Immunity, Transplantation and Infection. “The big message is the environment matters a lot.” Davis’ study was specific to the immune system, but it’s likely, he said, that the same environmental influence applies to other body systems — for instance, the nervous system — and overall health. And while there’s no doubt that genetics plays a huge role in certain diseases and health outcomes, the importance of DNA may be overstated.
Expansion Microscopy Stretches Limits of Conventional Microscopes
A new laboratory technique enables researchers to see minuscule biological features, such as individual neurons and synapses, at a nearly molecular scale through conventional optical microscopes. In a paper published in the journal Science, researchers at M.I.T. said they were able to increase the physical size of cultured cells and tissue by as much as five times while still preserving their structure. The scientists call the new technique expansion microscopy. The idea of making objects larger to make them more visible is a radical solution to a vexing challenge. By extending the resolving power of conventional microscopes, scientists are able to glimpse such biological mysteries as the protein structures that form ion channels and the outline of the membrane that holds the genome within a cell.
Newer Heart Attack Test 'could save women's lives'
Doctors could spot twice as many heart attacks in women by using a newer, more sensitive blood test, a study claims. The test looks for minute traces of a protein that signals that the heart muscle may have been damaged. Standard tests still used by much of the NHS only detect higher levels of this protein, called troponin. Research from the Royal Infirmary of Edinburgh shows the standard test misses many cases of heart attack in women with symptoms like chest pain. The British Heart Foundation-funded study, reported in the BMJ, included 1,126 men and women who had been admitted with a suspected heart attack. Using the standard troponin test, almost twice as many men as women were diagnosed as having a heart attack - 117 versus 55. When the researchers used the more sensitive test, the number of women diagnosed with heart attacks doubled to 111 or 22%. In comparison, the sensitive test only spotted a handful of extra cases among the men.
Tattoo-like Sensor Can Detect Glucose Levels Without Painful Finger Prick
Scientists have developed the first ultra-thin, flexible device that sticks to skin like a rub-on tattoo and can detect a person's glucose levels. The sensor, reported in a proof-of-concept study in the ACS journal Analytical Chemistry, has the potential to eliminate finger-pricking for many people with diabetes. The researchers made a wearable, non-irritating platform that can detect glucose in the fluid just under the skin based on integrating glucose extraction and electrochemical biosensing. Preliminary testing on seven healthy volunteers showed it was able to accurately determine glucose levels. The researchers conclude that the device could potentially be used for diabetes management and for other conditions such as kidney disease.
Questions Remain Over Role of PCA3 Assay in Prostate Cancer
The role of the prostate cancer antigen 3 (PCA3) assay (Hologic/Gen-Probe) in ruling out prostate cancer in men presenting for a repeat biopsy has been supported by a large American study. However, the place of the assay in assessing men presenting for an initial biopsy is less clear. It remains to be seen whether the results should be used as a continuous variable or dichotomized with cutoff values, and the value of the PCA3 assay in combination with other markers and patient-related data is still being examined. The study was published in the December issue of the Journal of Clinical Oncology. The findings are welcomed by Andrew J. Vickers, PhD, attending research methodologist at the Memorial Sloan Kettering Cancer Center in New York City
Portable 'blood test in a box' to Give Instant Diagnoses
For most of us, a blood test begins with a needle, a syringe and the promise it will all be over quickly. But at the back end, testing blood often requires transporting the vial to a clinic, a range of laboratory equipment and trained clinicians and doctors to get an accurate result. The whole process can take days, and in some cases even weeks. One Irish company says it has developed the solution -- a "clinic-in-a-box" that can test for a range of diseases or medical conditions in minutes, from just a single drop of blood. Cartridges packed with tiny beads with a molecular coating specific to the disease that is being investigated are loaded into the machine. A drop of blood is spun with the beads and any disease molecules present in the blood sample appear in the form long chains. Analyzing these samples under a green light immediately shows how much of the disease is present in the sample. Doctors would be equipped with cartridges specific to the diseases they may be diagnosing; from heart or liver disease to diabetes. The device has multiple applications and can be used in remote locations where access to laboratory facilities is limited or even non-existent. One of its major investors has been the European Space Agency who are looking to use the device in space.
Gene-Based Spit Test Shows Promise in Lung Cancer Detection
Medicare indicated recently that it might soon cover CT scans to check longtime smokers for early lung cancer, and these types of scans are becoming more common. Now, an experimental test may help determine whether lung nodules detected by those scans are malignant or not, researchers say. The test, which checks sputum (respiratory mucus) for chemical signals of lung cancer, was able to distinguish early stage lung cancer from noncancerous nodules most of the time, according to findings published Jan. 15 in the journal Clinical Cancer Research. "We are facing a tremendous rise in the number of lung nodules identified because of the increasing implementation of the low-dose CT lung cancer screening program," Dr. Feng Jiang, associate professor, department of pathology, University of Maryland School of Medicine, explained in a journal news release. "However, this screening approach has been shown to have a high false-positive rate," he added. "Therefore, a major challenge is the lack of noninvasive and accurate approaches for preoperative diagnosis of malignant nodules." Testing a patient's sputum for a group of three genetic signals – called microRNA (miRNA) biomarkers – may help overcome this problem, Jiang said.
Hospitals Aim to Better Match Blood Donors and Recipients
As researchers uncover more genetic variations in blood types, they are identifying new risks to patients needing transfusions. Hospitals and blood banks are turning to more precise genetic methods to screen blood donors and recipients to prevent a mismatch, which can be fatal. The first such test to be approved in the U.S., called PreciseType, which promises quicker, more accurate results than traditional lab testing methods, has been adopted by 15 health systems and 25 donor centers including the American Red Cross, which supplies about 40% of the nation’s blood. PreciseType and similar tests are already in use in Europe.
Vela Dx Launches CE-marked Sentosa SQ Colorectal Cancer NGS Panel
Vela Diagnostics announced the launch of its Sentosa SQ Colorectal Cancer next-generation sequencing panel, which has received the CE mark. The panel supports clinical decision making by identifying 112 clinically relevant hot spot mutations and sequence variants in target regions in 11 genes.
Intact Medical Clinches New FDA Clearance to Preserve Breast Biopsy Specimens
Intact Medical Corporation (Framingham, Mass) won FDA 510(k) clearance for its Intact excision system to be used to preserve removed breast tissue of up to 30mm in diameter. Once the area is prepared, the wand is inserted through a 6mm-8mm incision and the tip expands to surround the tissue. A 10 second burst of radiofrequency energy is delivered through the tip ablating the tissue around the sample and freeing it for easy removal. The sample maintains its architecture and is ready for standard histologic evaluation. The device comes with four different basket sizes that envelop around the sample, while the same wand is used with all four. With use of Intact, physicians can offer women the option of a fast and relatively simple procedure that can remove a lesion up to 30mm in diameter, while maintaining the lesion architecture for pathological analysis, versus capturing multiple samples of that tissue for analysis, which would not preserve architectural integrity.
GenomeDx Prostate Cancer Test Lands Medicare Coverage
GenomeDx Biosciences announced that national Medicare benefit administration contractor Palmetto GBA has issued a positive coverage policy for the firm's Decipher prostate cancer classifier. Decipher is a genomic, RNA expression-based test that predicts cancer aggressiveness with an assay of 22 validated biomarkers associated with metastatic disease. In multiple published studies, the test has proved to be more accurate than PSA, Gleason score, and other clinical risk factors in predicting metastatic disease in men following prostate surgery, the firm said in a statement. The test is used with men who have specific risk factors for cancer recurrence.
Australian Prostate Cancer Screening Guidelines
The Prostate Cancer Foundation of Australia and Cancer Council Australia recently issued updated guidance for detecting prostate cancer. The document, called “Draft Clinical Practice Guidelines PSA Testing and Early Management of Test-Detected Prostate Cancer,” aims to maximize the benefits and reduce the harms associated with using prostate specific antigen (PSA) testing as a screen for prostate cancer.
Could Vitamin A Deficiency be a Cause of Type 2 Diabetes?
A new study published in The Journal of Biological Chemistry claims to have identified a potential driver of type 2 diabetes: vitamin A deficiency. The researchers, from the Weill Cornell Medical College in New York, NY, say their findings may lead to new treatments for the condition. According to senior author Dr. Lorraine Gudas - chairman of the Department of Pharmacology at Weill Cornell - and colleagues, vitamin A boosts beta cell activity, meaning lack of the vitamin may play a role in the development of type 2 diabetes. There are two types of vitamin A. Preformed vitamin A, referred to as retinol, is present in meat, poultry, fish and dairy products, while pro-vitamin A, or beta-carotene, is found in many fruits and vegetables. Vitamin A aids cell growth and contributes to a healthy immune system and vision. Past studies have shown that, during fetal development, vitamin A is key for beta cell production. But Dr. Gudas and colleagues say it was unclear as to whether vitamin A played such a role in adulthood.
OHSU Star Researcher Louis Picker Unravels Another Mystery in Quest for HIV Cure
A pioneering Oregon Health & Science HIV researcher has unraveled another mystery in his quest for a cure. Dr. Louis Picker revealed in an article that his team has found the hiding place where the virus shields itself from an assault by the body's immune system. Now he has to create a strategy to breach the sanctuary. "The first thing we need to do in a cure is figure out what the barriers are," Picker said. "You peel back the onion until you get a good map of your enemy." Picker, associate director of OHSU Vaccine and Gene Therapy Institute, is one of the top researchers worldwide into a vaccine against HIV, the virus that causes AIDS. In 2013, he announced his team had developed a vaccine that immunized monkeys. Today, five years after they were infected, those monkeys are still virus free. "They're cured," Picker said.
How Blood Stem Cells Take Root in the Body
A see-through zebrafish and enhanced imaging provide the first direct glimpse of how blood stem cells take root in the body to generate blood. Reporting online in the journal Cell, researchers in Boston Children's Hospital's Stem Cell Research Program describe a surprisingly dynamic system that offers several clues for improving bone marrow transplants in patients with cancer, severe immune deficiencies and blood disorders, and for helping those transplants "take." "The same process occurs during a bone marrow transplant as occurs in the body naturally," says Zon. "Our direct visualization gives us a series of steps to target, and in theory we can look for drugs that affect every step of that process." "Stem cell and bone marrow transplants are still very much a black box—cells are introduced into a patient and later on we can measure recovery of their blood system, but what happens in between can't be seen," says Owen Tamplin, PhD, the paper's co-first author. "Now we have a system where we can actually watch that middle step."
Stem Cell Found to Reverse Type 1 Diabetes in Mice
A cell used to treat immune-related diseases has been found to spare islet cells from destruction, reversing type 1 diabetes. Mesenchymal stem cells (MSCs) were studied by researchers at the Harvard-affiliated Brigham and Women’s Hospital (BWH), with their results published in the journal Stem Cells. MSCs - a type of adult stem cell - possess anti-inflammatory and potent immune-suppressing effects. Previous preclinical trials have found administration could reduce blood sugar levels in non-obese diabetic mice, without the need for insulin.
Bone Stem Cells Shown to Regenerate Bones, Cartilage in Adult Mice
A stem cell capable of regenerating both bone and cartilage has been identified in bone marrow of mice. The cells, called osteochondroreticular (OCR) stem cells, were discovered by tracking a protein expressed by the cells. Using this marker, the researchers found that OCR cells self-renew and generate key bone and cartilage cells, including osteoblasts and chondrocytes. The discovery has implications for bone repair, the scientists say.
Scientists Discover Gene Tied to Profound Vision Loss
An exhaustive hereditary analysis of a large Louisiana family with vision issues has uncovered a new gene tied to the incurable eye disorder retinitis pigmentosa, according to a study led by scientists at The University of Texas Health Science Center at Houston (UTHealth). This family of eye diseases affects more than 200,000 people in the United States and millions worldwide. In the journal Investigative Ophthalmology & Visual Science, Stephen P. Daiger, PhD, and his colleagues report their discovery of a new gene tied to retinitis pigmentosa. The gene, hexokinase 1 (HK1), brings the total of genes associated with the disorder to more than 60.
Breast Cancer: Rates of Diagnosis and Survival 'vary by race'
A new study published in JAMA finds that among women in the US, the chance of being diagnosed with breast cancer in the early stages of the disease and the likelihood of surviving after such a diagnosis may be influenced by race and ethnicity, and this may be down to biological differences. According to the American Cancer Society, there will be around 231,840 new cases of invasive breast cancer - in which the cancer cells have spread beyond the breast ducts - diagnosed in the US this year and more than 40,000 deaths from the disease. It is already known that breast cancer incidence in the US varies by race and ethnicity. Some past studies investigating the reasons behind variations in breast cancer incidence and survival between ethnicities say it may be explained by differences in exposure to breast screening and examination, as well as the likelihood of receiving the required care after a breast mass is found. However, the researchers of this latest study - including Dr. Javaid Iqbal of Women's College Hospital in Toronto, Canada - say more and more research is pointing to biological factors as a potential explanation.
Oral HIV Vaccine Undergoing Testing
A new oral vaccine to prevent HIV infection that does not contain the HIV virus is currently being tested in clinical trials at the University of Rochester Medical Center. The study is designed by Beth Israel Deaconess Medical Center (BIDMC) and funded by the Bill & Melinda Gates Foundation. This novel vaccine that is administered in pill form contains a live adenovirus.
Birth Defects Drop 35% due to Adding Folic Acid to Flour
The number of babies born with a type of serious birth defect has fallen 35% since the USA began fortifying grains with a B vitamin called folic acid in 1998, a new report shows. Folic acid plays a crucial role in the earliest days of a pregnancy, studies indicate. Women who don't get enough folic acid have an elevated risk of giving birth to a child with spina bifida, which often causes paralysis. Adding folic acid to grains has prevented more than 1,300 babies a year from being born with spina bifida or related conditions, according to a report from the Centers for Disease Control and Prevention.
Johnson & Johnson Receives $115 Million for Ebola Vaccine Development
Johnson & Johnson said that newly formed groups supporting work on its experimental Ebola vaccine would receive 100 million euros ($115 million) from Europe's Innovative Medicines Initiative to speed development. The U.S. drugmaker earlier this month announced it had started clinical trials of its two-injection vaccine, which uses a booster from Denmark's Bavarian Nordic, making it the third such product to enter human testing. J&J has been seeking partners after committing up to $200 million to accelerate its Ebola vaccine program in October.
Scientists Find Antibiotic That Kills Bugs Without Resistance
Scientists have discovered a new antibiotic, teixobactin, that can kill serious infections in mice without encountering any detectable resistance, offering a potential new way to get ahead of dangerous evolving superbugs. Researchers said the antibiotic, which has yet to be trialled in humans, could one day be used to treat drug-resistant infections caused by the superbug MSRA, as well as tuberculosis, which normally requires a combination of drugs that can have adverse side effects.
Study Suggests Way to Fight Asian Tiger Mosquito
The Asian tiger mosquito, which can carry the dengue and chikungunya viruses, appears to spread from place to place along highways, according to a study of its recent dispersal throughout Panama. That discovery has important implications for mosquito control, the authors said. Spraying cars and trucks at highway checkpoints could be effective. And tactics already used against the local Aedes aegypti mosquitoes might need to be adjusted because the Asian tiger — formally known as Aedes albopictus — has different habits. In the paper, published by PLOS Neglected Tropical Diseases, scientists from the University of Panama and the Smithsonian Tropical Research Institute analyzed the spread of the tiger mosquito since it was first detected in eastern Panama City in 2002. (Scientists think it may have crossed the ocean in freighters carrying tires, which hold freshwater puddles.) By 2013, it was common in half the country.
OpenFDA: Making Federal Public Health Data Sets Accessible
Even skeptics about the responsiveness of an organization as large as the FDA have had to admit that the agency’s first chief health informatics officer, Taha Kass-Hout, has shaken things up with the creation of the Office of Informatics and Technology Innovation (OITI). Kass-Hout came to the FDA in March 2013 from the Centers for Disease Control and Prevention, where he had helped with the adoption of cloud computing. At the FDA, Kass-Hout’s first endeavor was the creation of openFDA, an initiative launched in June 2014 to make it easier for Web developers, researchers and the public to access public health data sets collected by the agency.
10 Strategies for Protecting Patient Data in 2015
Patients have little or no control over the privacy of their data, however, that’s the provider’s job. That is a whole lot harder than it used to be, given the increase in PHI-related data security incidents. Here are 10 strategies for both covered entities and their business associates to safeguard patient information in 2015 and beyond:
1. Demand organizational leadership engagement.
2. Make incident response management a priority.
3. Find and identify your data.
4. Control PHI workflow and minimize necessary workforce access.
5. Assess risks.
6. Prioritize third-party vendor management.
7. Get proactive.
8. Make privacy an integral part of new technology adoption.
9. Measure to improve.
10. Look for "non-standard" systems as potential PHI data stores.
HITRUST Forms Security Working Group
The Health Information Trust Alliance (HITRUST) announced a new working group designed to bolster health IT security systems increasingly threatened by cyber attacks. Acknowledging there are no standards in the healthcare system for recognizing vulnerabilities and sharing best practices to eliminate or mitigate these vulnerabilities, HITRUST said it is forming the Health Information Technology (HIT) and Medical Device Integrity and Security Program. The group will be made up of health information technology vendors, medical device manufacturers, and health information systems users.
7 Health IT Trends for 2015
Industry change in healthcare IT has been frenetic in the last few years, and 2015 shows no signs of any decrease in activity or intensity.
1. Finally using analytics to drive clinical change
2. ICD-10 will happen
3. The number of uninsured will continue to decline
4. Payers will make long-term investments
5. Telehealth finally starts – small
6. Personalized treatment plans ignored
7. Meaningful Use 3 refocused
Health IT VC Funding More Than Doubles in 2014
Healthcare technology had a great year for venture capital funding in 2014, raking in more than double the amount it did a year prior, according to a Mercom Capital Group report. The health IT sector saw 670 deals that brought in $4.7 billion in funds. That's a major boost from the 571 deals made in 2013 that totaled $2.2 billion.
New Zealanders are beginning to access their electronic health record via a patient portal provided by their GP.
Giving people direct access to their health information has many benefits and enable:
- better management of chronic conditions
- patients to have more input into their treatment,
- better use of individuals’ and clinicians’ time at face-to-face consultations.
- patients to become more aware if requested tests or results are not carried out or followed up, and will be able to raise this with clinicians.
- patients to become more proactive with their care and enable more ‘self-care’.
Curriculum Designed to Move Pathologists to the Forefront of Genomic Medicine is Now Available
A new educational resource—The Genomic Pathology Workshop Instructor’s Handbook and Toolkit—developed through a five-year, $1.3 million grant from the National Institutes of Health (NIH), is now available for pathology trainees worldwide. Developed by the Training Residents in Genomics (TRIG) Working Group with educational design support from the American Society for Clinical Pathology (ASCP), the program builds on a curriculum first developed at Beth Israel Deaconess Medical Center in Boston and provides the materials and guidance needed to implement structured and field-tested introductory training in genomic medicine. While geared towards pathology residents, the material and teaching methods are applicable to other healthcare specialties and providers.
Drugs in Dirt: Scientists Appeal for Help
US scientists are asking the public to join them in their quest to mine the Earth's soil for compounds that could be turned into vital new drugs. Spurred on by the recent discovery of a potential new antibiotic in soil, the Rockefeller University team, want to check dirt from every country in the world. They have already begun analysing samples from beaches, forests and deserts across five continents. But they need help getting samples.
On their Drugs From Dirt website, they say: "The world is a big place and we can't get to all of the various corners of it. "We would like some assistance in sampling soil from around the world. If this sounds interesting to you - sign up."
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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