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DLPSS|HEALTHCARE NEWS|January 29, 2015

DLPSS|HEALTHCARE NEWS|January 29, 2015

CDC. Centers for Disease Control and Prevention. CDC 24/7: Saving Lives. Protecting People.



A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services


January 29, 2015

News Highlights


  • CDC National Health Report
  • Survey Assesses Global Healthcare Concerns
  • Medical Genetics Labs Shine in 10-Year Proficiency Test Data
  • Steering Doctors to the Right Vitamin D Test
  • Early Detection of Heart Attacks Aided by Gold Nanoparticles
  • More Differences Than Similarities Are Found in Autistic Siblings
  • Scientists Find Gene Vital to Central Nervous System Development
  • Research Suggests Anti-inflammatory Protein May Trigger Plaque in Alzheimer’s Disease
  • How to Build a Better Flu Vaccine
  • FDA Debates Releasing Genetically Modified Mosquitoes Into Florida Keys
  • CMS Promises to Overhaul Open Payments Database
  • Strategy and Innovation Advisors Wants Predictive Analytics Included in HIT Strategic Plan
  • American Society of Clinical Oncology Tool to Use Large Swaths of Data to Improve Cancer Care


View Previous Issues - Healthcare News Archive


Leading News



CDC National Health Report
The CDC National Health Report 2014 offers a snapshot of our nation’s health, highlighting recent successes and challenges in fighting critical health problems in the United States (U.S.). The report finds Americans are living longer, healthier lives, but suggests that more work is needed to ensure that all Americans can achieve optimum health. The report includes recent trend data on life expectancy, common causes of death, and health behaviors. It includes a scientific paper (CDC National Health Report: Leading Causes of Morbidity and Mortality and Associated Behavior Risk and Protective Factors -- United States, 2005-2013), a Report Highlights Adobe PDF file document, and at-a-glance dashboard charts. The CDC National Health Report web site offers quick access to key resources and tools to advance public health work.
Survey Assesses Global Healthcare Concerns
Costs, waiting times, accessibility and quality were top issues for adults in 10 countries.
Healthcare costs, shorter waiting times, greater accessibility to healthcare, and improved quality of service were the top priorities identified in a global survey of 10,000 individuals recently conducted by GE Healthcare. The survey—designed to assess the areas of healthcare most concerning to people—covered 10 countries with very different healthcare infrastructures, including the United Kingdom, the United States, Brazil, Australia, India, China, South Korea, Japan, Russia, and Indonesia.
Of note to laboratorians, 69% of respondents worldwide said they’d like to have quicker access to diagnostic results, 47% said they’d like to have wearable technology that transmits information quickly to their doctors, and 63% said they’d like their doctors to have instant access to their medical records. Also, survey respondents said the following was “very” or “fairly” important to them: 87% in favor of technology to monitor health when away from the hospital, 85% in favor of electronic health records, 79% in favor of wearable technology, and 71% in favor of the storage of data in “cloud technology.”
Kids' Vaccination Schedule Updated
An updated childhood and adolescent immunization schedule was released by the CDC, following recommendations from the Advisory Committee on Immunization Practices, the American Academy of Pediatrics, the American College of Obstetrics and Gynecologists, and the American Academy of Family Physicians. An AAP policy statement published in Pediatrics explained that the revised schedule now indicates that children ages 2 to 8 should receive influenza vaccinations starting at age 2, with some children needing a double dose. But double doses will no longer be recommended for children at ages 9 to 10. The schedule also now includes a recommendation that children 6 months to just under 12 months who travel outside the U.S. should get a measles, mumps, and rubella vaccination.
Scientists Work to Contain Modified Organisms to Labs
Could genetically modified bacteria escape from a laboratory or fermentation tank and cause disease or ecological destruction? This is not known to have occurred. But two groups of scientists reported that they had developed a complex technique to prevent it from happening. The scientists have given a common type of bacterium a unique genetic code that makes it dependent for survival on unnatural amino acids that must be fed to it. If such organisms escaped into the wild, where those amino acids are not available, they would die. “It really addresses a longstanding problem in biotechnology,” said Farren Isaacs, an assistant professor of molecular, cell and developmental biology at Yale, who led one of the research groups. He called it a “really compelling solution to engineering biocontainment, or biological barriers that limit the spread and survival of organisms in natural environments.”

Laboratory Testing / Diagnostics


 
Medical Genetics Labs Shine in 10-Year Proficiency Test Data
Ten-year data from the molecular genetics Surveys in the CAP proficiency testing program show that U.S. clinical laboratories are making extremely accurate calls using molecular genetics assays. At the 2014 meeting of the Association for Molecular Pathology, Karen E. Weck, MD, and Iris Schrijver, MD, presented results from seven of the proficiency Surveys that the CAP/ACMG Biochemical and Molecular Genetics Resource Committee oversees. Dr. Weck is the chair of the committee; Dr. Schrijver is past chair. “We have seen excellent performance of molecular genetics testing in general,” Dr. Weck says. “Overall sensitivity has been greater than 95 percent and specificity greater than 99 percent for all analytes we have evaluated thus far.” (Analysis of females for Fragile X had a sensitivity of 95.5 percent; all other sensitivities were around 99 percent.) “Laboratories are doing a good job across the board,” Dr. Schrijver tells CAP TODAY. The committee members selected seven Surveys for analysis ranging from commonly performed cystic fibrosis testing to complex Fragile X syndrome testing, which has multiple components. They published results from these analyses over the past two years in a series of articles in Genetics in Medicine.
Steering Doctors to the Right Vitamin D Test
Vitamin D tests can be challenging for clinicians to get right. “In our institution, we found that 66% of the 1,25 dihydroxyvitamin D tests were ordered in error, and that in these cases, 25-OH vitamin D was the intended test,” explained Jane Dickerson, PhD, DABCC, and Michael Astion, MD, PhD, who co-authored a Patient Safety Focus article on the subject. “As laboratorians know, 25-OH vitamin D is most useful in nutritional assessment, primarily due to its longer half-life of approximately 3 weeks. 25-OH vitamin D is elevated with vitamin D intoxication and decreased with malabsorption, nutritional deficiency, and in liver disease. Conversely, the circulating half-life of 1,25 dihydroxyvitamin D is relatively short (4–6 hours), limiting utility for overall vitamin D assessment,” they explained. However, the 1,25 dihydroxyvitamin D test can be useful for diagnosis of renal dysfunction, in conjunction with parathyroid hormone. “It is elevated in sarcoidosis and primary hyperparathyroidism and decreased in renal failure and hypoparathyroidism,” wrote Dickerson and Astion.
Early Detection of Heart Attacks Aided by Gold Nanoparticles
NYU Polytechnic School of Engineering professors have been collaborating with researchers from Peking University on a new test strip that is demonstrating great potential for the early detection of certain heart attacks. Kurt H. Becker, a professor in the Department of Applied Physics and the Department of Mechanical and Aerospace Engineering, and WeiDong Zhu, a research associate professor in the Department of Mechanical and Aerospace Engineering, are helping develop a new colloidal gold test strip for cardiac troponin I (cTn-I) detection. The new strip uses microplasma-generated gold nanoparticles (AuNPs) and shows much higher detection sensitivity than conventional test strips. The new cTn-I test is based on the specific immune-chemical reactions between antigen and antibody on immunochromatographic test strips using AuNPs.  The routine use of gold nanoparticles in therapy and disease detection in patients is still years away: longer for therapeutic applications and shorter for biosensors.
Incidental NIPT Finding Leads Leuven Team to New Blood Test for Hodgkin Lymphoma
An incidental finding from a noninvasive prenatal test has prompted at team at the University of Leuven in Belgium to develop a blood test for Hodgkin lymphoma that analyzes circulating cell-free DNA (ccfDNA). In a proof-of-concept study published in Lancet Haematology, the researchers demonstrated that they can identify genomic imbalances found in Hodgkin lymphoma cells in cell-free DNA from the blood of patients diagnosed with early and advanced disease, and monitor these profiles over the course of treatment. The noninvasive assay, which relies on shotgun next-generation sequencing of ccfDNA, could be useful for identifying patients unlikely to respond to therapy and provide an alternative for monitoring therapy response.
Novel Approach to Visualize & Measure Protein Complexes in Tumors
Cancer diagnosis and treatment decisions are often hampered by a lack of knowledge of the biological processes occurring within the tumor.  Moffitt Cancer Center researchers have developed a new approach to analyze these processes with a technique called proximity ligation assays (PLA).  PLA allows specific protein complexes to be visualized and measured in cancer specimens.  This may aid in patient treatment decisions in the future. These protein complexes may become new biomarkers to help physicians diagnose and treat patients with a certain class of drugs called receptor tyrosine kinase inhibitors. Protein complex analysis by PLA may also help physicians determine how patients become resistant to these drugs.
Diagnosing Infectious Diseases Using MALDI TOF MS
Laboratories around the world are quickly embracing MALDI-TOF MS as a fast, easy, cost-effective and accurate way to identify grown bacteria and fungi, based on mass distribution of bacterial proteins in cultured bacteria or fungi, according to a new review published in Clinical Chemistry. In the past, identifying bacteria and fungi has been a challenging process with many steps, depending on the organism. In MALDI (matrix-assisted laser desorption ionization), a matrix “assists in the desorption and ionization of microbial analytes through the energy of a laser,” wrote author Robin Patel in “MALDI-TOF MS for the Diagnosis of Infectious Diseases.” Patel is director of the infectious diseases research laboratory at Mayo Clinic in Rochester, Minnesota.
NanoVelcro Chip Now Makes CTCs Easy to Snap Off for Analysis
A number of technologies have been invented in recent years for capturing circulating tumor cells (CTCs) from whole blood. There are limitations to all of them, and one common problem is keeping the cells alive while removing them from the screening device. This is normally due to the same mechanism that grabs on to the circulating tumor cells and doesn’t let them go. Now the research team has developed a pretty simple release method so the cells can go under the microscope for analysis. As the name implies, the NanoVelcro chip has a hairy array of nanoscale wires, each with antibodies of proteins found in CTCs at the tips. As the blood passes by the wire hairs, the CTCs stick to them. In the process of figuring out how to detach the cells, the team discovered that by lowering the temperature of the environment around the hairs from body temperature to 4° Celsius, the cells pop off and can be collected in pure, undamaged form.
Companies Increasingly Aim to Tap Into Growing Liquid Biopsy Market
With evidence building that monitoring a tumor's mutational landscape can be done by evaluating circulating tumor DNA or circulating tumor cells, companies are increasingly looking to move into the liquid biopsy market. Over the last several years, researchers have published a number of studies demonstrating that next-generation sequencing of ctDNA or CTCs can give a representative picture of a patient's tumor. As a result, a few startup companies and spinouts from academic research teams performing such methods have sprung up, including Guardant Health, Personal Genome Diagnostics, and Inivata. Chronix Biomedical is also offering an NGS-based ctDNA test for patients in Germany as a supplemental prostate specific antigen test.
However, over the last month, the larger players in cancer genomics have all announced their intentions to get into the market, as well. At the JP Morgan Healthcare Conference in San Francisco earlier this month, Illumina, Sequenom, and Foundation Medicine all mentioned plans for developing liquid biopsy tests. Meantime, Thermo Fisher Scientific signed a distribution agreement with Cynvenio for its LiquidBiopsy platform that extracts and isolates CTCs from a blood draw and prepares them for genomic analysis. Qiagen's PCR-based test to assess EGFR mutation status from ctDNA in non-small cell lung cancer received CE-IVD marking, and the company continues to develop technologies to enable both PCR- and NGS-based analysis of ctDNA, CTCs, and RNA found in exosomes. In addition, Trovagene aims to distinguish itself by developing tests that can analyze tumor DNA in either blood or urine.

Research and Development



More Differences Than Similarities Are Found in Autistic Siblings
Most siblings with a diagnosis of autism do not share the same genetic risk factors for the disorder and are as distinct in their behaviors as any brothers and sisters, scientists reported in a study that came as a surprise to many doctors, if not to parents. Scientists analyzed genetic material from 85 families, using a technology called whole-genome sequencing. Unlike other approaches, which illuminate a sample of a person’s genetic material, the whole-genome technique maps out the entire voluminous recipe, every biological typo, every misplaced comma or transposed letter. Each of the families had two children with a diagnosis of autism. Experts said the report, in the journal Nature Medicine, would most likely encourage changes in clinical practice.
Scientists Find Gene Vital to Central Nervous System Development
Using Washington University’s zebrafish facility, graduate student Sarah Ackerman and senior author Kelly Monk, PhD, identified a gene that regulates how well the wiring of the central nervous system is insulated. Healthy insulation is vital for the speedy propagation of nerve cell signals. The finding, in zebrafish and mice, may have implications for human diseases like multiple sclerosis, in which this insulation is lost. The study appears Jan. 21 in Nature Communications. In the new study, the researchers found that when the protein Gpr56 is disabled, there are too few oligodendrocytes to provide insulation for all of the axons. Still, the axons looked normal. And in the relatively few axons that were insulated, the myelin also looked normal. But the researchers observed many axons that were simply bare, not wrapped in any myelin at all. Without Gpr56, the cells responsible for applying the insulation failed to reproduce themselves sufficiently, according to the study’s senior author, Kelly R. Monk, PhD, assistant professor of developmental biology. These cells actually matured too early instead of continuing to replicate as they should have. Consequently, in adulthood, there were not enough mature cells, leaving many axons without insulation.
Research Suggests Anti-inflammatory Protein May Trigger Plaque in Alzheimer’s Disease
University of Florida researchers have uncovered the mechanism by which anti-inflammatory processes may trigger Alzheimer’s disease. This anti-inflammatory process might actually trigger the build-up of sticky clumps of protein that form plaques in the brain. These plaques block brain cells’ ability to communicate and are a well-known characteristic of the illness. The finding suggests that Alzheimer’s treatments might need to be tailored to patients depending on which forms of Apolipoprotein E, a major risk factor for Alzheimer’s disease, these patients carry in their genes. The researchers have shown that the anti-inflammatory protein interleukin 10, or IL-10, can actually increase the amount of apolipoprotein E, or APOE, protein — and thereby plaque — that accumulates in the brain of a mouse model of Alzheimer’s, according to the study, published recently in the journal Neuron.
Dementia 'Linked' to Common Over-the-counter Drugs
A study has linked commonly used medicines, including over-the-counter treatments for conditions such as insomnia and hay-fever, to dementia. All of the types of medication in question are drugs that have an "anticholinergic" effect. Experts say people should not panic or stop taking their medicines. In the US study in the journal JAMA Internal Medicine, higher doses and prolonged use were linked to higher dementia risk in elderly people. The researchers only looked at older people and found the increased risk appeared when people took drugs every day for three years or more.
Salmonella Lubbock Discovery Gains International Confirmation
The Pasteur Institute in Paris, the international center for Salmonella, has confirmed that a new serotype has been discovered at Texas Tech University.Salmonella Lubbock will be the newest entry in the Salmonella Atlas, published periodically by the U.S. Centers for Disease Control and Prevention (CDC) in Atlanta. The research that led to the discovery of the new Salmonella Lubbock was intended to reduce the likelihood of Salmonella in food. CDC has already logged more than 2,500 Salmonella serotypes. Most are rare and not much is known about them, although there are about 100 that account for most human infections.
New Data Identifies MicroRNA-8 as Essential to Female Mosquito Reproduction
Researchers from the University of California, Riverside reported new data linking a microRNA to key reproductive processes in female mosquitoes, a finding that could lead to new ways to control the spread of these disease-carrying insects. Female mosquitoes require a blood meal for reproduction, which provides the underlying mechanism for the spread of vector-borne diseases in humans, including malaria, dengue fever, and West Nile virus. The acquisition of blood triggers a number of events within several tissues of female mosquitoes, including in the fat body, an adipose tissue involved in energy metabolism, immunity, and reproduction, according to a paper published in the Proceedings of the National Academy of Sciences.

Public Health and Patient Safety



How to Build a Better Flu Vaccine
With this season’s flu vaccine only protecting 1 in 4 people, scientists are working on new manufacturing techniques and virus-killing methods to update the creaky, 80-year-old process now used to inoculate the population. Sometime this season, after many people got vaccinated, a strain of influenza that causes unusually serious illness evolved, letting the bug circumvent a protection that is still only about 60 percent effective in a good year. This year’s vaccine is much worse, at just 23 percent, according to the U.S. Centers for Disease Control and Prevention. To make the vaccine more effective, scientists and companies are reworking everything from its production to its distribution to the way it attacks the virus. The goal is to find methods that offer more protection and can react more quickly to unexpected changes.  The flu virus can replicate in eight hours, so when it mutates, the change can slip past people’s immunity and quickly become dominant, said Ruben Donis, associate director for policy, evaluation and preparedness in the CDC’s influenza division. That makes it difficult for the world’s flu experts, who meet every February to formulate a vaccine for the next flu season in North America, as little as eight months away.
FDA Debates Releasing Genetically Modified Mosquitoes Into Florida Keys
Millions of genetically modified mosquitoes could be released in the Florida Keys if British researchers win approval to use the bugs against two extremely painful viral diseases. Never before have insects with modified DNA come so close to being set loose in a residential U.S. neighborhood. "This is essentially using a mosquito as a drug to cure disease," said Michael Doyle, executive director of the Florida Keys Mosquito Control District, which is waiting to hear if the Food and Drug Administration will allow the experiment. Dengue and chikungunya are growing threats in the U.S., but some people are more frightened at the thought of being bitten by a genetically modified organism. More than 130,000 signed a Change.org petition against the experiment. Even potential boosters say those responsible must do more to show that benefits outweigh the risks.
Deadly Bacteria on Medical Scopes Trigger Infections
The deadly pattern of illnesses began to emerge in 2012 at hospitals in Seattle, Pittsburgh, [and] Chicago. In each case, the culprit was a bacteria known as CRE [Carbapenem-Resistant Enterobacteriaceae], perhaps the most feared of superbugs, because it resists even "last defense" antibiotics — and kills up to 40% of the people it infects. And in each case, investigators identified the same source of transmission: a specialized endoscope, threaded down the throat of a half-million patients a year to treat gallstones, cancers and other disorders of the digestive system. They found that the devices, often called duodenoscopes, accumulate bacteria that are not always removed by conventional cleaning, so infections can pass from patient to patient. The FDA says in a written statement to USA TODAY that it is "aware of and closely monitoring" the infection risks associated with the scopes. "Some parts of the scopes may be extremely difficult to access and clean thoroughly," the agency adds, "and effective cleaning of all areas of the duodenoscope may not be possible." The agency is studying the problem and working with manufacturers.
E-Cigarettes Can Churn Out High Levels of Formaldehyde
Vapor produced by electronic cigarettes can contain a surprisingly high concentration of formaldehyde — a known carcinogen — researchers reported. The findings, described in a letter published in the New England Journal of Medicine, intensify concern about the safety of electronic cigarettes, which have become increasingly popular. "I think this is just one more piece of evidence amid a number of pieces of evidence that e-cigarettes are not absolutely safe," says David Peyton, a chemistry professor at Portland State University who helped conduct the research. The e-cigarette industry immediately dismissed the findings, saying the measurements were made under unrealistic conditions.http://www.nejm.org/doi/full/10.1056/NEJMc1413069?query=TOC
Sepsis Screening Tool Spots Subtle Signs, Saves Lives
A simple screening tool predicts sepsis early in trauma patients and reduces mortality, according to a new study. "The findings show that the sepsis screening tool is a reliable and valid method for the early identification of sepsis in the trauma population," said Laura Moore, MD, from the University of Texas Health Science Center in Houston. Dr. Moore presented the results at the Society of Critical Care Medicine 44th Critical Care Congress. The screening tool involves the twice-daily assessment of white blood cell count, respiratory rate, temperature, and heart rate. Each measure is given a score of 0 to 4. "If the score is 4 or higher, the nurse then calls the clinician, who comes to the bedside to evaluate for the presence of a possible infection. If an infection is detected, the appropriate sepsis therapies are initiated," she explained.
Measles Outbreak at Disney Raises Vaccination Questions
Public health experts say the disease was probably brought to the amusement park packed with holiday tourists by a foreign visitor, but it has spread in part due to the lower numbers of Americans who have been opting to receive the immunisation shots. The US government announced in 2000 that measles had been eradicated in the country, but the disease has seen a steady rebound since then. The US Centers for Disease Control reports there were 644 new measles cases in 27 states last year - the highest number since the early 1990s. The vaccination levels for children ages 19 to 35 months in the US stood at 91.9% in 2013, below the 92% rate that ensures "herd immunity" that offers protection for those who can't get immunized for medical reasons and adults whose immunisation has worn off. In Colorado, where two of the Disney-related cases have appeared, the rate was a national-low 86%.

Health IT



CMS Promises to Overhaul Open Payments Database
The Centers for Medicare & Medicaid Services (CMS) has vowed to learn from the mistakes it made in its first round of publishing data about financial relationships between providers and healthcare manufacturing companies to improve the fairness and accuracy of information in its next round of disclosures. Here's some of the changes that Law360 states CMS hopes to make as part of what Data Sharing and Partnership Group Director Douglas Brown called "a pretty in-depth overhaul" of its reporting system:
  • Prevent records from being submitted with overlapping data that confuses providers with the same names
  • Fix the issue of having to match provider names with National Provider Identifier numbers, which not all physicians have
  • Allow principal investigators who lead clinical trials to review reported payments
Strategy and Innovation Advisors Want Predictive Analytics Included in HIT Strategic Plan
The Health IT Policy Committee's strategy and innovation work group, outlined draft recommendations for the Office of the National Coordinator for Health IT's updated Federal Health IT Strategic Plan. The workgroup's changes and suggestions for the plan include clarification of language to, among other things:
  • Emphasize a focus on improving health and well-being
  • Explain how a health-oriented infrastructure would function
  • Reflect a greater focus on health equity
Workgroup members also said predictive analytics should be included in the plan, and that ONC should articulate a vision for collection, ownership, protection and uses of personal health information.
American Society of Clinical Oncology Tool to Use Large Swaths of Data to Improve Cancer Care
The American Society of Clinical Oncology (ASCO) is creating a tool that will allow it to cull patient data from millions of electronic health records in an effort to improve cancer care, according to an announcement on the platform. ASCO is using a database called CancerLinQ, which will be developed using an in-memory data management and application platform. The tool will also be able to securely process and analyze the patient data to provide clinical decision support to physicians. "CancerLinQ will help improve cancer care by delivering the latest information to doctors no matter where they practice so that patients can receive high-quality, state-of-the-art care regardless of where they live," Clifford A. Hudis, M.D., ASCO's immediate past president, said in a statement.
Distressed Docs Turn Up Heat on ONC
A coalition of 35 physician organizations led by the American Medical Association says docs are fed up their electronic health records and the multitude of requirements that come from the federal meaningful use program. They have a seven-point plan for relief. The medical societies urge ONC to adopt their seven-point plan for improving EHR certification.
  1. Decouple EHR certification from the meaningful use program
  2. Reconsider alternative software testing methods
  3. Establish greater transparency and uniformity on user-centered design testing and process results
  4. Incorporate exception handling into EHR certification
  5. Develop CCDA guidance and tests to support exchange
  6. Seek further stakeholder feedback
  7. Increase education on EHR implementation
The coalition elaborated on its concerns for patient safety.
Top 5 Innovation Investments U.S. States Are Making
Up to 25 states plan on moving ahead in 2015 with State Health Innovation Plans (SHIPs) funded by the U.S. Centers for Medicare and Medicaid Services (CMS), according to a report from Accenture. Accenture outlined the top investment areas by the states currently participating in the program are as follows:
  1. Patient-centered medical homes
  2. Telehealth
  3. All-payer claims databases
  4. Self-service tools
  5. Lower-cost labor models
Patients Increasingly Open to Video Doctor Visits
Patient acceptance of telehealth services is growing with 64 percent of patients recently surveyed by Harris Poll on behalf of telehealth company American Well saying they are willing to consider a video chat with their doctor instead of an in-person visit. Based on responses from 2,019 consumers, a majority are open to the convenience and reduced wait times involved in an e-visit. The survey characterizes telehealth as a way for health systems to offer a lower-cost, more convenient alternative to in-person care. Another recent study found that a telehealth visit saves about $100 or more compared to the estimated cost for in-person care. It put the cost of the average telehealth visit at $40 to $50, while in-person care can cost as much as $176.

Other News



Top Legal Minds Against FDA's Proposal to Regulate Lab Tests
A new legal whitepaper authored by two of America's most prominent lawyers argues that the US Food and Drug Administration's (FDA) plan to regulate lab developed tests (LDTs) more similarly to traditional medical devices lacks legal justification and is therefore unlawful. The legal analysis is co-authored by  Paul Clement, the former US Solicitor General and a frequent litigator before the Supreme Court, and Laurence Tribe, a Harvard professor and a prominent legal scholar, on behalf of the American Clinical Laboratory Association (ACLA), which the duo are representing in its fight against FDA's proposed LDT policy.
APHL Submits Comment to FDA on Oversight of Laboratory Developed Tests
APHL formally submitted comments to FDA responding to its draft guidance for the oversight of laboratory developed tests. APHL's comments outlined several recommendations to FDA encouraging them to modify the framework to preserve critical public health laboratory functions. Access the comments on APHL's website.
Syphilis Cases on the Rise Locally and Nationally; FDA OK's Wider Use of Rapid Screening Test
The rise in cases is alarming enough that the Cleveland Department of Public Health is stepping up its ongoing campaign to urge people - specifically gay and bisexual males ages 16 to 35 who represent most of the new cases - to know their health status, said Health Commissioner Myron Bennett. And the Ohio Department of Health is in the early stages of exploring the feasibility of purchasing rapid syphilis screening tests for use in select local health departments across the state. Cleveland accounted for 28 of the county's primary and secondary syphilis cases, for a rate of 7.2 per 100,000 people.

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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