A Weekly Compilation of Clinical Laboratory and Related Information
From The Division Of Laboratory Systems
July 02, 2015
- Prevalence of Diagnosed and Undiagnosed HIV Infection — United States, 2008–2012
- Reviewing Guidelines for Primary HPV Screening in Women Age 25 to 29
- FDA Draft Guidance Covers Direct Marking of Devices with Identifiers
- Liquid Biopsy: Its Impact on Cancer Diagnostics
- Pancreatic Cancer Blood Test Breakthrough
- Finger-Prick, Blood Test for Ebola Takes Just Minutes
- Sex Differences in Pain Pathway – Male and Female Mice Utilize Different Immune Cells to Process Pain, a Study Shows
- Lab-made Blood to Enter Human Trials in 2 Years
- Blood, Saliva Tests May Spot Head and Neck Cancers Early
- Health Panel Recommends Cautious Approach to Meningitis B Vaccine
- Cocktail of Chemicals Trigger Cancer – Global Taskforce Calls for Research into How Everyday Chemicals in Our Environment Cause Cancer
- Drug-Resistant Bacteria Lurk in Crowded Afghan War Clinic
- NATO Working with South Dakota Telemedicine Hub
- Hospitals Turn to Big Data to Identify Risks in the ICU
- Covered California's Data-Collection Plans Raise Privacy Concern
View Previous Issues - Healthcare News Archive
Prevalence of Diagnosed and Undiagnosed HIV Infection — United States, 2008–2012
Persons unaware of their human immunodeficiency virus (HIV) infection contribute nearly one third of ongoing transmission in the United States. Among the estimated 1.2 million persons living with HIV in the United States in 2011, 14% had undiagnosed infections. To accelerate progress toward reducing undiagnosed HIV infection, CDC and its partners have pursued an approach that includes expanding HIV testing in communities with high HIV infection rates. To measure the prevalence of diagnosed and undiagnosed HIV infection for the 50 states and the District of Columbia (DC), CDC analyzed data from the National HIV Surveillance System. In 42 jurisdictions with numerically stable estimates, HIV prevalence in 2012 ranged from 110 per 100,000 persons (Iowa) to 3,936 per 100,000 (DC). The percentage of persons living with diagnosed HIV ranged from 77% in Louisiana to ≥90% in Colorado, Connecticut, Delaware, Hawaii, and New York. In 39 jurisdictions with numerically stable estimates, the percentage of HIV cases with diagnosed infection among men who have sex with men (MSM) ranged from 75% in Louisiana to ≥90% in Hawaii and New York. These data demonstrate the need for interventions and public health strategies to reduce the prevalence of undiagnosed HIV infection. Because the percentage of persons with undiagnosed HIV varies by geographic area, efforts tailored to each area's unique circumstances might be needed to increase the percentage of persons aware of their infection.
Reviewing Guidelines for Primary HPV Screening in Women Age 25 to 29
In January 2015, the Society of Gynecologic Oncology (SGO) and the American Society for Colposcopy and Cervical Pathology (ASCCP), with input from five other professional associations, published interim clinical guidance on the use of primary high-risk human papillomavirus (hrHPV) testing in cervical cancer screening.1 The action followed the decision by the FDA in April 2014 to grant the first approval of an HPV test for use as a first-line screening test (primary HPV testing).
The guidance document supports primary HPV screening, using an FDA-approved test, in women 25 and older as an alternative to current U.S. cytology-based cervical cancer screening methods. Importantly, the new age threshold of 25 for the use of HPV testing is lower than the age threshold set by guidelines issued in 2012 by the American Cancer Society (ACS), ASCCP, and the American Society for Clinical Pathology (ASCP), which recommend HPV testing in addition to a Pap test (also known as co-testing) for women ages 30 to 65.
Summary of Interim Guidance (2015)
Published by Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, and five other professional associations:
- A negative hrHPV test provides greater reassurance of low CIN3+ risk than a negative cytology result.
- Based on limited data, triage of hrHPV-positive women using a combination of genotyping for HPV 16 and 18 and reflex cytology for women positive for the 12 other hrHPV genotypes appears to be a reasonable approach to managing hrHPV-positive women.
- Re-screening after a negative primary hrHPV screen should occur no sooner than every three years.
- Primary hrHPV screening should not be initiated prior to 25 years of age.
FDA Draft Guidance Covers Direct Marking of Devices with Identifiers
The FDA on June 25 released a draft guidance on the agency's requirements for direct marking of medical devices with a unique device identifier (UDI). When finalized, this draft document will assist industry, particularly labelers, as defined under 21 CFR 801.3, and FDA staff in understanding FDA’s requirements for direct marking of devices for unique device identification purposes. Under 21 CFR 801.45, “[a] device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.”http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm
Prepublication Standards – New and Revised Laboratory Standards for Individualized Quality Control Plans (IQCP)
On January 1, 2016, The Joint Commission will implement a new voluntary quality control (QC) option for clinical laboratories. The Individualized Quality Control Plan (IQCP) will allow laboratories to customize QC policies and procedures based on a risk assessment of their health care setting. IQCP will be applicable to all specialties and subspecialties except pathology and will replace the existing Equivalent Quality Control (EQC) requirements in the Quality System Assessment for Nonwaived Testing (QSA) chapter of the Comprehensive Accreditation Manual for Laboratory and Point-of-Care Testing (CAMLAB).
Liquid Biopsy: Its Impact on Cancer Diagnostics
An estimated 1.6 million breast biopsies and one million prostate biopsies are performed each year in the United States. Tissue biopsies are invasive, whether performed during surgery, via a needle puncture, or as part of an endoscopic procedure. Additionally, these invasive approaches carry the risk of infection or other complications for the patient. Advanced lung cancer is a good example in this context, since a tissue biopsy often cannot be performed, even by a CT-guided fine needle technique, because the tumor or metastasis is sitting in an inaccessible part of the lung. Often, a tissue biopsy cannot be done because the patient’s poor condition makes the procedure too risky. Even when a core needle biopsy or fine needle aspiration can be performed successfully, it is possible that after many pathological and histological examinations, there is not enough remaining tumor material to perform molecular companion diagnostic testing. Such tests guide treatment decisions for targeted therapies—for example EGFR and BRAF gene mutations or ALK fusions are relevant in various cancer types—and thus a lack of tissue or tissue of poor quality can limit treatment options. It is estimated that a tissue biopsy is not evaluable in up to 25 percent of cases of advanced non-small cell lung cancer (NSCLC), for example. Recent large clinical studies now have clearly shown that, when a tissue biopsy is unavailable for any reason, blood can act as a surrogate for tissue samples to determine a predictive tumor biomarker and guide personalized treatment decisions. NSCLC is again a prime example, since a high specificity, sensitivity, and concordance to the tissue result was shown for the assessment of the EGFR mutation status from plasma samples before administration of certain tyrosine kinase inhibitors. Similar studies are ongoing for targeted therapies in various other cancers, such as colorectal and skin cancer. In addition to predictive testing, liquid biopsy also can support disease prognosis.
Not yet Sure
One of the hopes for liquid biopsies is that clinicians can keep pace with mutations that crop up in patients' tumors and adjust treatment plans accordingly, but Technology Review's Antonio Regalado reports that the data isn't in yet on the accuracy of these tests or whether they help extend patients' lives. Many insurers in the US, he notes, say liquid biopsies are unproven and don't cover their use, though the American Society of Clinical Oncology and the US National Cancer Institute have both announced trials to examine how well targeted drugs work in conjunction with DNA testing.
Pancreatic Cancer Blood Test Breakthrough
Scientists believe they are close to a blood test for pancreatic cancer - one of the hardest tumours to detect and treat. The test, which they describe as "a major advance", hunts for tiny spheres of fat that are shed by the cancers. Early results published in the journal Nature showed the test was 100% accurate. Experts said the findings were striking and ingenious, but required refinement before they could become a cancer test. The team at the Anderson Cancer Centre at the University of Texas looked for the unique signatures of cancer in these fatty exosomes. They noticed one protein, called proteoglycan glypican-1, was found in much higher levels in people with pancreatic cancer. Further tests on the blood of 270 people showed it was 100% accurate at distinguishing between cancers, other pancreatic disorders and healthy tissue. One of the researchers Dr Raghu Kalluri told the BBC News website: "We think the ability to identify and isolate cancer exosomes is a major advance and provides the possibility of immensely benefiting our patients."He said the need for such a test was "huge" and it was "not too far" from the clinic.
Finger-Prick, Blood Test for Ebola Takes Just Minutes
Public health officials may soon be able to screen patients for Ebola at border crossings and hospitals with a finger-prick blood test that takes mere minutes. The development of the rapid diagnostic test, reported in The Lancet, represents a significant victory for scientists around the world who have been experimenting over the past year with all manner of vaccines, treatments and other ways of eradicating the virus. Developing a way of confirming Ebola in a patient has been one of the top priorities. In the early stages the symptoms -- chest pain, cough, nausea -- can look like many other illnesses, making it very difficult for doctors to triage -- to determine who should be quarantined and who to send home. It can often take days or longer for laboratory tests, the current standard, to return a positive or negative result. "Delays like this result not only in the failure to diagnose and treat Ebola-infected patients, but also in individuals without Ebola being admitted to holding units where they may be subsequently infected with the virus," explained Nira Pollak, an associate medical director of the infectious diseases diagnostic laboratory at Boston Children's Hospital who is a co-author of the study. The new test was evaluated in two government-run treatment centers in Sierra Leone, one of the hardest hit countries in the epidemic. The research team, which also included scientists from Harvard Medical School, compared the accuracy of the rapid test with the laboratory test in 106 individuals suspected of having Ebola. The rapid test identified 100 percent of all infected patients who also got positive results with the lab test.
Nanometric Sensor Designed to Detect Herbicides Can Help Diagnose Multiple Sclerosis
The early diagnosis of certain types of cancer, as well as nervous system diseases such as multiple sclerosis and neuromyelitis optica, may soon be facilitated by the use of a nanometric sensor capable of identifying biomarkers of these pathological conditions. The nanobiosensor was developed at the Federal University of São Carlos (UFSCar), Sorocaba, in partnership with the São Paulo Federal Institute of Education, Science & Technology (IFSP), Itapetininga, São Paulo State, Brazil. It was originally designed to detect herbicides, heavy metals and other pollutants. The procedure can be as simple as placing a drop of the patient's cerebrospinal fluid on a glass slide and observing its interaction with the nanobiosensor. The next step for the group is to research biomarkers for these diseases that have not been completely mapped, including antibodies and antigens, among others.
New Pan-European Digital Pathology Network Aims to Transform Diagnosis and Treatment of Cancer and Other Diseases
- A new digital pathology solution allows pathologists to examine tissues in high-resolution on their computer screens from any network location and easily get second opinions.
- Previously pathologists would have to assess physical slides under a microscope and post them by mail for a second opinion. This could result in delays and risk slides being lost or damaged.
The digital pathology network’s central hub will be based in Labco’s laboratories in Madrid, Spain. It will initially connect a network of approximately 50 pathologists in Spain and 15 in the UK, all of whom are highly specialized in their respective clinical fields. There are also plans to extend to more laboratories across Europe. This will connect pathologists from Labco’s pan-European network that provides services to over 25 million patients annually through over 160 laboratories and 150 clinics in France, Switzerland, Belgium, Italy, Spain, Portugal and the United Kingdom.
Using EHRs to Follow Up on Abnormal Creatinines
In the June issue of the American Journal of Medicine, researchers describe how Kaiser Permanente’s Creatinine Safety Program is helping the organization detect patients with chronic kidney disease (CKD) earlier by using electronic health records (EHRs) to follow up on single abnormal creatinine results. Over a four-year period, the researchers followed up on 6,981 abnormal results with a repeat creatinine, and 3,668 of those patients were diagnosed with confirmed CKD. The researchers commented that the ambulatory care environment, in which 84% of the initial abnormal creatinine results were reviewed, “is an under recognized area where diagnostic errors are not uncommon and failure to follow up on abnormal tests results can occur routinely.”
Sex Differences in Pain Pathway – Male and Female Mice Utilize Different Immune Cells to Process Pain, a Study Shows
The physiological differences between males and females go far beyond reproduction; they may even include how an animal processes pain, according to a study published (June 29) in Nature Neuroscience. “This is not the usual type of sex difference that people usually report,” said study coauthor Jeffrey Mogil, a pain geneticist at McGill University in Montreal. His team found that male and female mice use completely different cell types to relay pain signals from the immune system to the nervous system. Scientists who study the interactions between immune cells and neurons have long turned to microglia, macrophage-like immune cells that reside in the central nervous system, as the key intermediate between the two systems.
Lab-made Blood to Enter Human Trials in 2 Years
The UK's NHS (National Health Service) Blood and Transplant say manufactured blood will be used in clinical trials with human volunteers within 2 years. The aim is one of several that the joint England and Wales special health authority has entered into with top universities to develop transfusion, transplantation and regenerative medicine over the next 5 years. The intention is not to replace human donation, says Dr. Nick Watkins, NHS Blood and Transplant assistant director of research and development, but to offer specialist treatment for specific patient groups. The health authority say there is a need to increase the availability of better-matched blood for patients with rare blood types. These include patients with blood conditions like sickle cell anaemia and thalassemia, who require regular blood transfusions.
Blood, Saliva Tests May Spot Head and Neck Cancers Early
Scientists report they've found DNA from head and neck cancer tumors in patients' blood and saliva samples, a development that potentially could lead to early diagnosis of these malignancies. Although not yet ready for real-world use, such tests could also help in planning and monitoring treatment, the Johns Hopkins University researchers said. "Tumor DNA has potential to be used as a marker for screening, early detection, monitoring during treatment and surveillance after cancer treatment," said lead researcher Dr. Nishant Agrawal, an associate professor of otolaryngology head and neck surgery. "In the near future, there will be a noninvasive test that can be used to monitor cancer," Agrawal said. The report was published June 24 in the journalScience Translational Medicine.
Genomic Prostate Score Predicts PCa Recurrence, Adverse Pathology
Genomic Prostate Score (GPS), a 17-gene molecular assay, strongly and independently predicts adverse pathology and time to biochemical recurrence in men with low- to intermediate-risk prostate cancer (PCa), a new study confirms. Investigators led by Jennifer Cullen, MPh, PhD, of the Department of Defense, Center for Prostate Disease Research, in Rockville, Md., tested the validity of GPS using biopsies from 431 men with very low to intermediate-risk PCa from 2 U.S. military medical centers. The researchers assessed GPS' abilities to predict adverse pathology at radical prostatectomy, biochemical recurrence, and metastasis.
New Knowledge: Parkinson's Disease May Begin in the Gut
A major epidemiological registry-based study from Aarhus University and Aarhus University Hospital indicates that Parkinson's disease begins in the gastrointestinal tract; the study is the largest in the field so far. The chronic neurodegenerative Parkinson's disease affects an increasing number of people. However, scientists still do not know why some people develop Parkinson's disease. Now researchers from Aarhus University and Aarhus University Hospital have taken an important step towards a better understanding of the disease. New research indicates that Parkinson's disease may begin in the gastrointestinal tract and spread through the vagus nerve to the brain. "Our study shows that patients who have had the entire vagus nerve severed were protected against Parkinson's disease. Their risk was halved after 20 years. However, patients who had only had a small part of the vagus nerve severed where not protected. This also fits the hypothesis that the disease process is strongly dependent on a fully or partially intact vagus nerve to be able to reach and affect the brain," she says. The research project has just been published in the internationally recognised journal Annals of Neurology.
Scanadu Has Consumer Self-Test Device under Review by the FDA as Part of Its Mission to Enable Patients to Monitor Their Health without the Need for Clinical Pathology Laboratory Tests
Scanadu’s device is called the ScanaFlo and is designed to collect biometric data from consumers using a variety of methods, including urine specimens. Now gathering study data needed to launch a review by the Food and Drug Administration (FDA) is a low-cost lab urinalysis device that returns results via a smartphone for conditions such as pregnancy and diabetes. More significant for pathologists and clinical laboratory executives, this handy point-of-care device is capable of doing tests for traditional medical laboratory tests, ranging from glucose and leukocytes to bilirubin and creatinine. The device was invented at Scanadu, Inc., a health-tech startup based at NASA Ames Research Center in Mountain View, California. It is a new low-cost lab urinalysis kit that uses a smartphone to return test results on liver, kidneys, urinary tract, and metabolic functions. The company uses imaging and sound analysis, molecular diagnostics, data analytics, and a suite of algorithms to create devices that offer consumers comprehensive, real-time health data on mobile devices.
Health Panel Recommends Cautious Approach to Meningitis B Vaccine
A panel of health experts stopped short of recommending that all American adolescents and young adults be vaccinated against a dangerous strain of meningitis that has caused outbreaks at Princeton University and the University of California campus in Santa Barbara, opting instead to let doctors decide whether to give the vaccine. A committee of outside medical and public health experts convened by the Centers for Disease Control and Prevention voted, 14 to 1, to recommend the more limited use of the vaccine in people ages 16 to 23. The vaccine is new and relatively costly and the illness is rare, a combination that seemed to tip the balance toward a more cautious approach.
Cocktail of Chemicals Trigger Cancer – Global Taskforce Calls for Research into How Everyday Chemicals in Our Environment Cause Cancer
A deadly list of 50 chemicals the public is exposed to on a daily basis may trigger cancer when combined, according to new research published today. A global taskforce of 174 scientists from leading research centres across 28 countries studied the link between mixtures of commonly encountered chemicals and the development of cancer. The study selected 85 chemicals not considered carcinogenic to humans and found 50 supported key cancer-related mechanisms at exposures found in the environment today. Current research estimates chemicals could be responsible for as many as one in five cancers. With the human population routinely exposed to thousands of chemicals, the effects need to be better understood to reduce the incidence of cancer globally.
Drug-Resistant Bacteria Lurk in Crowded Afghan War Clinic
A frontline hospital in Afghanistan already stretched by rising war casualties is facing another, invisible danger that is only beginning to come to light: highly contagious strains of drug-resistant bacteria which are making treatment harder. While drug resistance is a problem in hospitals the world over, early evidence from tracking by Medecins Sans Frontieres (MSF) in the last two years suggests it may be acute in Afghanistan. At the trauma center in the northern city of Kunduz, where Afghan forces are battling Taliban militants, staff have identified nearly 100 cases of multi-drug resistant bacteria, or nearly 30 percent of samples tested, since last year.
Eat Protein before Carbohydrates to Lower Post-Meal Glucose
In a new study, researchers from Weill Cornell Medical College in New York City, NY, found that the order in which different types of food are consumed has a significant impact on post-meal glucose and insulin levels in obese people. Writing in the journal Diabetes Care, the authors suggest their findings may have dietary implications for diabetic and other high-risk patients. For people with type 2 diabetes, it is important to maintain normal glucose levels after eating, because if their blood sugar level spikes then they are at increased risk of complications, including hardening of the arteries and heart disease, which can eventually lead to death. When the vegetables and protein were eaten before the carbohydrates, the researchers found that glucose levels were 29%, 37% and 17% lower at the 30, 60 and 120-minute checks, compared with when carbohydrates were consumed first. Also, insulin was found to be significantly lower when the participants ate vegetables and protein first.
NATO Working with South Dakota Telemedicine Hub
NATO leaders are working with a telemedicine hub in southeast South Dakota to develop a multinational system that could deliver medical services remotely during natural or man-made disasters. Representatives from NATO nations, including Romania, the United Kingdom and the U.S., are visiting Avera Health's telemedicine center in Sioux Falls this week to look at the technology and equipment options available to provide healthcare services from distant locations. The goal of the NATO-funded research project is to increase survival rates in emergency situations, when immediate access to medical specialists is not always possible. "This project is aiming at the creation of the multinational capacity in responding to major situations, disasters, civil emergencies, in countries where we would send our teams and they may need to consult experienced physicians at the distant from where they are," said Romanian interior ministry official Dr. Raed Arafat, who is the NATO director for the project. The program is being funded by NATO's Science for Peace and Security Programme.
Hospitals Turn to Big Data to Identify Risks in the ICU
Intensive care units (ICUs), seeking to reduce avoidable deaths, can harness big data to identify trends that may increase patient risks, according to the Wall Street Journal. ICUs admit more than 5 million patients a year, and mortality rates range from 10 percent to 29 percent. Many of these deaths have roots in preventable complications, such as hospital-acquired infections, blood clots and delirium due to oversedation. Hospitals have taken numerous steps to address avoidable ICU complications such as investing in more robust infection prevention programs. Now, however, the WSJ reports, some hospitals are testing an approach that incorporates years of medical data and records, many of which have never been analyzed together before.
Covered California's Data-Collection Plans Raise Privacy Concerns
Despite security concerns surrounding both public and private collection of health plan enrollees' data, California officials say their plan to collect medical data from the state-run exchange's 1.8 million customers is for the greater good, the L.A. Times reports. Covered California wants to collect data on customers' medications, doctor visits and hospital stays in order to measure care quality, and ultimately push health insurers to provide greater value via public disclosure of plan performance.
Google Develops mHealth Wristband
Google is developing a mHealth wristband for pharma clinical trials and drug tests to provide research teams with real-time data on patient vital signs, from pulse and heart rates to light exposure and noise level monitoring. While the device will be used by patients and lab research participants, it will not be sold directly to consumers, according to Bloomberg. "Our hope is that this technology could unlock a new class of continuous, medical-grade information that makes it easier to understand these patterns and manage serious health conditions," Andy Conrad, head of the life sciences team at Google, told CNN.
Watson’s Next Feat? Taking on Cancer
IBM is training Watson to be a cancer specialist. The idea is to use Watson’s increasingly sophisticated artificial intelligence to find personalized treatments for every cancer patient by comparing disease and treatment histories, genetic data, scans and symptoms against the vast universe of medical knowledge. Such precision targeting is possible to a limited extent, but it can take weeks of dedicated sleuthing by a team of researchers. Watson would be able to make this type of treatment recommendation in mere minutes. The IBM program is one of several new aggressive health-care projects that aim to sift through the huge pools of data created by people’s records and daily routines and then identify patterns and connections to predict needs. It is a revolutionary approach to medicine and health care that is likely to have significant social, economic and political consequences. Lynda Chin, a physician-scientist and associate vice chancellor for the University of Texas system who is overseeing the Watson project at MD Anderson Cancer Center, said these types of programs are key to “democratizing” medical treatment and eliminating the disparity that exists between those with access to the best doctors and those without.
Examination of Genetic Testing Labs
There's promise and excitement surrounding genetic and genomic tests, but the New York Times reports there's also the potential for fraud as such testing has transformed into a $6 billion industry. "It sounds so legitimate — who doesn't want safe medicine?" Howard McLeod, the medical director of the personalized medicine institute for Moffitt Cancer Center, tells the Times. The entire lab industry, it notes, is under scrutiny by the US Justice Department regarding its relationship with physicians. The Times in particular focuses on the case of Renaissance RX. According to the Times, Renaissance received some $130 million in Medicare funds and $55 million from investment firm TPG for a sweeping personalized medicine study, and doctors received $75 for each patient they enrolled in the study and tracked.
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