A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
January 15, 2015
- Glaxo, Merck Ebola Vaccine Trials to Start in West Africa
- Proposed Regulation of Lab Tests Draws Mixed Reviews at Workshop
- New Guidance on Food Allergy Diagnostics
- FDA Grants First CLIA Waiver for Nucleic Acid-based Flu Diagnostic Test
- Blood Test to Help Smokers 'Find Best Way to Quit'
- Study Says Biopsies are Safe
- HPV Integration Study Reveals Hotspots Related to Cervical Cancer Development
- Defying Textbook Science, Study Finds New Role for Proteins
- FDA Expands EHR Data Analytics With Active Surveillance System
- HIV Workplace Infections Very Rare
- Healthcare IT in 2015: What to Expect
- HHS Calls Stage 3 Rule 'Flexible, Clearer Framework'
View Previous Issues - Healthcare News Archive
Glaxo, Merck Ebola Vaccine Trials to Start in West Africa
Late-stage trials of Ebola vaccines may begin in Liberia by the end of this month, and in Sierra Leone and Guinea in February, the World Health Organization said. The trial in Liberia will test an experimental vaccine from GlaxoSmithKline Plc (GSK) and another developed jointly by Merck & Co. (MRK) and NewLink Genetics Corp. (NLNK) in about 27,000 people, Marie-Paule Kieny, the WHO’s assistant director-general of health systems and innovation, said at a Geneva briefing. Both vaccines have demonstrated an “acceptable safety profile” during early-stage trials, and data on how well they stimulate the immune system against Ebola will be available in the next two to four weeks, Kieny said. Johnson & Johnson (JNJ), which said this week it started early-stage testing of its vaccine, is also making plans for advanced testing in the Ebola-affected countries, she said.
Proposed Regulation of Lab Tests Draws Mixed Reviews at Workshop
A Food and Drug Administration proposal to regulate laboratory-developed tests could upend a clinical sector that provides thousands of tests to healthcare providers every day, raising costs and potentially limiting patient access, detractors say. But advocates of new regulation say some patients have been harmed by poor oversight of the tests. Some women who were tested for ovarian cancer with a specific laboratory-developed blood test, for example, chose to have their ovaries removed as a result of inaccurate test results, according to Laura Koontz, director of policy for the Ovarian Cancer National Alliance. Both sides got their say during a two-day workshop featuring dozens of speakers representing laboratories, healthcare providers and patients who raised questions about the impact of the proposed regulation. The medical device industry supports the proposed regulation. But other groups, such as the American Hospital Association and the American Medical Association, say FDA regulation of the tests will raise costs and potentially hinder patient access. Another opponent, the American Clinical Laboratory Association, argues that the agency doesn't have the statutory authority to issue the proposed regulation.
Stakeholders Ask FDA to Educate Labs on Agency Thinking, Terminology Before Finalizing LDT Guidance
During the second day of a public workshop on the regulation of laboratory-developed tests (LDTs), industry stakeholders asked the US Food and Drug Administration to produce several publications to better explain how they can meet the agency's requirements. Specifically, workshop attendees requested FDA publish a paper explaining how it gauges the risk a test poses to public health; put out a document outlining the areas where the agency will harmonize its regulations with existing requirements under the Centers for Medicare & Medicaid Services; and issue another, revised LDT draft guidance before publishing a final version. "It's my understanding that the entire framework is predicated on risk classification," Amy Miller, executive VP of the Personalized Medicine Coalition, told FDA. Noting that labs are unaccustomed to FDA processes and terminologies, Miller and others at the meeting asked FDA for more clarification on how it plans to classify LDTs into high- (Class III), moderate- (Class II), and low-risk (Class I) categories. These risk classifications are critical for labs to understand, since a test's risk category maps to the premarket requirements it will have to meet.
After Enterovirus 68 Outbreak, a Paralysis Mystery
A nationwide outbreak of a respiratory virus last fall sent droves of children to emergency departments. The infections have now subsided, as researchers knew they would, but they have left behind a frightening mystery. Since August, 103 children in 34 states have had an unexplained, poliolike paralysis of an arm or leg. Each week, roughly three new cases of so-called acute flaccid myelitis are still reported to the Centers for Disease Control and Prevention. Is the virus, called enterovirus 68, really the culprit? Experts aren’t certain: Unexplained cases of paralysis in children happen every year, but they are usually scattered and unrelated. After unusual clusters of A.F.M. appeared this fall, enterovirus 68 became the leading suspect, and now teams of researchers are racing to figure out how it could have led to such damage. “It’s unsatisfying to have an illness and not know what caused it,” said Dr. Samuel Dominguez, an epidemiologist and an infectious disease specialist at Children’s Hospital Colorado, which has had the largest cluster of patients.
New Guidance on Food Allergy Diagnostics
Food allergies affect more than 1-2%—and less than 10%—of the population. The types of foods causing the most significant allergic reactions include peanuts, tree nuts, fish, shellfish, milk, eggs, wheat, soy, and seeds. To help identify those affected by this problem, three allergy associations in the United States recently released parameters for diagnosing and managing food allergies—defined as an “adverse health effect arising from a specific immune response that occurs reproducibly on exposure to a given food.” The document was prepared by the Joint Task Force on Practice Parameters, representing the American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); and the Joint Council of Allergy, Asthma & Immunology (JCAAI) and was published in the Journal of Allergy and Clinical Immunology.
The parameters warn against using unproven tests to diagnose food allergy, such as the allergen-specific IgG measurement, cytotoxicity assays, applied kinesiology, provocation neutralization, and hair analysis.
FDA Grants First CLIA Waiver for Nucleic Acid-based Flu Diagnostic Test
The U.S. Food and Drug Administration granted the first waiver to allow a nucleic acid-based test, the Alere i Influenza A & B test, to be used in a greater variety of health care settings. The test was previously only available for use in certain laboratories. Influenza, commonly known as the flu, is a contagious respiratory illness caused by two types of influenza viruses: Type A and Type B. Flu infections can range from mild to severe and can sometimes lead to hospitalization and death. According to the Centers for Disease Control and Prevention, more than 200,000 people in the United States are hospitalized from seasonal flu-related complications each year. Because the FDA granted a waiver under the Clinical Laboratory Improvement Amendments (CLIA), the Alere i Influenza A & B test can be distributed to a broad variety of non-traditional laboratory sites, including physicians’ offices, emergency rooms, health department clinics, and other health care facilities.
Blood Test to Help Smokers 'Find Best Way to Quit'
A blood test could help people choose a stop-smoking strategy that would give them the best chance of quitting, research in a Lancet journal suggests. Studies show as many as 60% of people who try to give up start smoking again in the first week. But researchers argue measuring how quickly a person breaks down nicotine could boost the chances of success. Other experts say the cost-effectiveness of these extra tests would need to be assessed. Some scientists suggest people who break it down more quickly may crave more cigarettes and in turn find it harder to quit. In this study, researchers from the University of Pennsylvania in the US enlisted some 1,240 people on different smoking cessation programmes. They checked each volunteer's blood to see if nicotine was broken down at a normal or slow rate. Scientists found people who broke down nicotine at a normal rate had a better chance of quitting while using varenicline than those using nicotine replacement patches.
Another Look at Vitamin D
U.S. Preventive Services Task Force finds evidence insufficient for screening asymptomatic adults.
There is still insufficient evidence to determine whether it’s worthwhile to screen for vitamin D deficiency in asymptomatic adults, and the lack of uniformity among testing methods used by laboratories makes interpreting data difficult, according to the U.S. Preventive Services Task Force (USPSTF) in a recommendation statement and systemic review recently published in the Annals of Internal Medicine. Despite the task force’s findings, there seems to be a compelling rationale to test for vitamin D deficiency, wrote Robert P. Heaney, MD, and Laura A. G. Armas, MD, of Creighton University in Omaha, Nebraska, in an accompanying editorial. “General assurances that one probably needs extra vitamin D are not as compelling a motivator as knowing one’s number,” they explained.
Chronix Team Publishes Validation Study of NGS-based Liquid Biopsy Test
Chronix Biomedical has published a clinical validation study of a next-generation sequencing-based test that analyzes circulating cell-free DNA to gauge whether the patient is at high risk for prostate cancer and should go on to receive a biopsy. The company is now offering the test out of its clinical laboratory in Göttingen, Germany and plans to launch it in the UK, other European countries, and the US. Chronix CEO Howard Urnovitz told GenomeWeb that the test is aimed at patients whose prostate specific antigen levels are "in the gray zone," which he defined as a PSA level of between 4 ng/ml and 30 ng/ml, and is designed to serve as a supplementary PSA test. The goal is to provide a clearer guide of who is at high risk for developing prostate cancer and should receive further testing, reducing the numbers of unnecessary biopsies. In its validation study, which was published this month in Clinical Chemistry, Chronix collaborated with researchers at Vanderbilt University.
Infectious Disease MDx 2014: qPCR for Ebola; Disease Panels; Isothermal Amplification
Using PCR to diagnose infectious disease penetrated public awareness in an unprecedented new way last year when, during the height of public focus on Ebola, the technique began popping up even in general stories about the disease in popular media outlets. Indeed, PCR remains the molecular analysis technology of choice for detecting and diagnosing infectious diseases, especially considering the single-target nature of many of these assays and the fact that PCR has traditionally excelled at quickly and accurately detecting one or a few targets, but has been difficult to multiplex on a larger scale. Although it is unclear how FDA Emergency Use Authorization [EUA] of a diagnostic ultimately impacts commercialization, the number of companies developing Ebola tests since the FDA declared an Ebola emergency in August continues to grow. Recent authorization of Roche's LightMix Ebola Zaire brought the total number of Ebola EUA recipients to seven, with firms such as Becton Dickinson, BioInnovation Solutions, STMicroelectronics, and Ubiquitome also recently announcing intent to seek it.
QIAGEN Announces First-Ever Regulatory Registration of a Lung Cancer Companion Diagnostic Based on Liquid Biopsies
QIAGEN announced the CE-IVD marking of its novel liquid biopsy-based companion diagnostic that analyzes circulating nucleic acids obtained from blood samples to assess an important genomic mutation in patients with non-small cell lung cancer (NSCLC), the most common form of this cancer. The registration, which applies to more than 30 European countries, makes the new therascreen EGFR RGQ Plasma PCR kit the first-ever regulated companion diagnostic assay that has demonstrated clinical utility for guiding treatment decisions in patients with solid tumors based on the analysis of molecular biomarkers obtained from a body fluid (liquid biopsy).
Biomarkers Help ID Lung Disease in RA
Two biomarkers detected in the serum of patients with rheumatoid arthritis (RA) helped identify those who were developing the potentially lethal extra-articular complication of interstitial lung disease and also correlated with the stage of pulmonary disease, researchers reported. In a cohort of Chinese patients with RA, the mean serum concentration of matrix metalloproteinase (MMP)-7 was 3.06 ng/mL in those with no interstitial lung disease detected on high resolution CT scans, rising to 5.35 ng/mL in patients with the typical pulmonary changes such as ground-glass and reticular abnormalities, honeycombing, and bronchiectasis (P=0.005), according to Dana P. Ascherman, MD, of the University of Miami, and colleagues.
Specialists Split Over HPV Test's Role in Cancer Screening
Two medical groups say doctors could replace the Pap smear with a different test to screen many women for cervical cancer. But that recommendation, included in an "interim guidance" released, is highly controversial; other experts call it premature. Last spring the Food and Drug Administration approved a test for the HPV virus as a primary screening test for the malignancy. That move by the FDA prompted an intense debate about whether an HPV test should merely supplement or perhaps replace the Pap test. As a result, the American Society for Colposcopy and Cervical Pathology and the Society of Gynecologic Oncology convened an expert committee to review how the HPV test should be used. In the resulting report, released in the journal Gynecologic Oncology, the committee concludes that doctors could consider the HPV test a primary screening test for women beginning at age 25. Still, not all doctors agree. Members of the American Congress of Obstetricians and Gynecologists, for example, say it's just too soon to make such a change; some worry the results will unnecessarily frighten many women.
Do Some Clinical Laboratory Companies Oversell Prenatal Genetic Screening Tests?
A growing number of media stories claim medical lab companies that develop genetic screening assays oversell the accuracy of such tests and fail to educate parents and doctors about the risks of false positives and false negatives. In response to growing concerns by consumers about the accuracy of some proprietary genetic screening assays, several media outlets have begun reporting on this sector of the clinical laboratory industry. What gives these news stories emotional punch is the fact that patients use these proprietary medical laboratory tests to make decisions that can be life-changing. In its story about these tests, the Boston Sunday Globe used the headline “Oversold prenatal tests spur some to choose abortions.”
Accuracy of Marketing Claims Concerning Prenatal Lab Tests
The reporter raised questions about the accuracy of the marketing claims some clinical laboratories performing these prenatal tests make to physicians. The story also addressed the lack of understanding physicians and patients have about scientific sensitivity and specificity of genetic screening tests.
A Crowded Field for Noninvasive Prenatal Screening Tests
Growing market expected to reach $3.6 billion by 2019.
Prenatal screening for detection of a wide range of monogenic disorders and chromosomal abnormalities has been available to prospective parents for over 40 years. But these screening techniques, including seroscreening and ultrasound, have false positive rates of 5% and 10–15%, respectively, requiring that 1 in 20 women face a decision of whether to undergo invasive testing that may include amniocentesis, chorionic villus sampling, or, rarely, cordocentesis. All of these procedures involve some risk with fetal loss rates of approximately 1 in 300 procedures, according to the American College of Obstetricians and Gynecologists (ACOG). But the discovery of circulating fetal DNA (cfDNA) in the maternal circulation and the development of advanced sequencing technologies have led some scientists and clinicians to predict that antenatal diagnosis will become a predominately noninvasive process that will usher in the era of noninvasive prenatal testing (NIPT). The introduction of technologies such as digital PCR and next-generation sequencing (NGS) or massively parallel sequencing (MPS) have enabled accurate estimation of very small differences in chromosome-specific sequences in maternal blood, thus providing an approach to NIPT that can be used in clinical practice.
Global Clinical Laboratory Services Market Will Reach US$241.37 Billion by 2019
Transparency Market Research, U.S.-based intelligence firm has published a new report titled, "Clinical Laboratory Services Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019". The global market for clinical laboratory services market was valued at US$162.71 billion market in 2012 and is expected to reach US$241.37 billion market in 2019, growing at a CAGR of 5.8% from 2013 to 2019.
Study Says Biopsies are Safe
Cancer biopsies do not cause the disease to spread, says a new study that dispels a common myth. "This study shows that physicians and patients should feel reassured that a biopsy is very safe," said study senior investigator Dr. Michael Wallace, a gastroenterologist and professor of medicine at the Mayo Clinic in Jacksonville, Fla. The study included more than 2,000 people with pancreatic cancer. Those who received a biopsy using a technique called fine needle aspiration lived longer and had better outcomes than those who did not have a biopsy. "We do millions of biopsies of cancer a year in the U.S., but one or two case studies have led to this common myth that biopsies spread cancer," Wallace said in a clinic news release. The findings in the Jan. 9 online issue of the journal Gut are likely to apply to other cancers because fine needle aspiration is used to biopsy many types of tumors, Wallace said.
HPV Integration Study Reveals Hotspots Related to Cervical Cancer Development
A team from China, Saudi Arabia, and Denmark has mapped human papillomavirus integration sites in cervical cancer genomes, cell lines, or pre-cancerous cervical neoplasias, garnering hints about integration hotspots that may contribute to cervical cancer development. As they reported inNature Genetics, the researchers used genome sequencing and high-throughput viral integration detection (HIVID) — a method based on sequence data and computational breakpoint detection — to track down HPV integration sites in more than 100 cervical carcinoma tumors, dozens of cervical intraepithelial neoplasias (CINs), and five HPV-positive cell lines. The resulting map of HPV integration sites provided a peek at sequences that are frequently altered by these integrations, along with the genes associated with them. It also pointed to the possibility of increasing HPV integration during the progression from CIN to cervical cancer. "The integration hot spots identified in our study could be used as biomarkers for early personalized treatment and prognosis assessment of patients with cervical carcinoma," researchers from Huazhong University of Science and Technology, BGI-Shenzhen, and other institutions wrote.
Defying Textbook Science, Study Finds New Role for Proteins
Open any introductory biology textbook and one of the first things you'll learn is that our DNA spells out the instructions for making proteins, tiny machines that do much of the work in our body's cells. Results from a study published on Jan. 2 in Science defy textbook science, showing for the first time that the building blocks of a protein, called amino acids, can be assembled without blueprints - DNA and an intermediate template called messenger RNA (mRNA). A team of researchers has observed a case in which another protein specifies which amino acids are added. "This surprising discovery reflects how incomplete our understanding of biology is," says first author Peter Shen, Ph.D., a postdoctoral fellow in biochemistry at the University of Utah. "Nature is capable of more than we realize." "In this case, we have a protein playing a role normally filled by mRNA," says Adam Frost, M.D., Ph.D., assistant professor at University of California, San Francisco (UCSF) and adjunct professor of biochemistry at the University of Utah. He shares senior authorship with Jonathan Weissman, Ph.D., a Howard Hughes Medical Institute investigator at UCSF, and Onn Brandman, Ph.D., at Stanford University. "I love this story because it blurs the lines of what we thought proteins could do."
Does Creatinine say More About Muscle Quality Than Mass?
Lower urinary creatinine excretion linked to end-stage renal disease and death, independent of fat-free mass.
Urinary creatinine may be revealing more about muscle quality than muscle mass, researchers reported. In an analysis of data from the CRIC study, there was a strong association between urinary creatinine and risk of end-stage renal disease (ESRD) and death, but the same wasn't true for bioelectrical impedance, a measure of muscle mass, reported F. Perry Wilson, MD, of Yale University School of Medicine in New Haven, Conn., and colleagues, in theClinical Journal of the American Society of Nephrology online. "The interesting finding is that the urinary creatinine, long thought to be a simple proxy for muscle mass, is telling us more information than we once thought," Perry said in an email to MedPage Today.
UCLA Stem Cell Researchers Make Breakthrough for Disease Treatment
Researchers at the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA have developed for the first time a method that defines the reprogramming of skin or blood cells into pluripotent stem cells (cells that have the potential to develop into any type of cell. The research is likely to lead to the development of new treatments. The findings were published online on January 5 in the journal Cell. The research team led by Dr. Kathrin Plath, professor of biological chemistry, has established a new methodology that defines the unique stages whereby specialized cells are reprogrammed into stem cells that resemble those found in the embryo. Induced pluripotent stem cells (iPSCs) are similar to human embryonic stem cells in that both types of cells have the unique ability to self-renew and have the flexibility to become any cell in the human body. However, iPSC cells are generated by reprogramming skin or blood cells and do not require an embryo.
Vitamin D May Boost Colon Cancer Survival, Study Finds
Higher vitamin D levels in patients with advanced colon cancer appear to improve response to chemotherapy and targeted anti-cancer drugs, researchers say. "We found that patients who had vitamin D levels at the highest category had improved survival and improved progression-free survival, compared with patients in the lowest category," said lead author Dr. Kimmie Ng, an assistant professor of medicine at Harvard Medical School in Boston. Those patients survived one-third longer than patients with low levels of vitamin D -- an average 32.6 months, compared with 24.5 months, the researchers found. However, colon cancer patients shouldn't try to boost vitamin D levels beyond the normal range, one expert said.
Scientists Identify New Gene That Drives Triple-negative Breast Cancer
Triple-negative breast cancer is when cancer growth does not involve estrogen receptors, progesterone receptors and human epidermal growth factor (HER2) receptors. As such, triple-negative breast cancer does not respond to hormone therapy, meaning individuals with this subtype have a poorer prognosis than those with other subtypes. Basal cell breast cancer is the most common form of triple-negative breast cancer. The study researchers - including joint first author Dr. Walid Khaled of the Welcome Trust Sanger Institute and the University of Cambridge in the UK - note that scientists are in the process of investigating new ways to treat triple-negative breast cancer. Much research has focused on identifying genes associated with the condition, though to date, very few have been found. For this latest study, published in the journal Nature Communications, Dr. Khaled and colleagues took a different approach to identifying such genes; they assessed alterations to genes that influence the actions of stem cells and developing tissues, as past research from the team has indicated that these alterations affect cancer development.
Reducing BCL11A activity found to reduce cancer-like behavior
By assessing these gene alterations among breast cancer cells from nearly 3,000 patients, the team found that a gene called BCL11A was particularly active in triple-negative breast cancer.
FDA Expands EHR Data Analytics With Active Surveillance System
The Food and Drug Administration’s Sentinel Initiative, one of the first active surveillance infrastructures focused on identifying patient safety issues related to pharmaceuticals and other medical products, will expand past its pilot phase this year, announced Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research in a blog post. As a planned continuation of the Mini-Sentinel project, the full-scale system will allow the FDA to leverage advanced EHR data analytics by scanning millions of files for adverse events linked to drugs that fall under the Administration’s purview.
HIV Workplace Infections Very Rare
HIV infections acquired at work have become very rare: In the last 14 years, only one known health care worker — who was stuck by a needle in a lab — has become infected on the job with HIV, the federal government said. Since 1985, when the AIDS epidemic began, 58 people are confirmed to have acquired HIV on the job, while another 150 “possible” cases have been reported, said the Centers for Disease Control and Prevention (CDC).
LA BioMed Develops Promising Vaccine to Combat MRSA
Grappling with one of the world’s deadliest contagions for more than a decade without a breakthrough, the country’s leading infectious disease researchers have high hopes for a vaccine developed locally. The NDV-3 vaccine aims to prevent deadly Methicillin-resistant Staphylococcus aureus(MRSA), which attaches itself to skin and embeds in bodily organs. The so-called superbug is responsible for more yearly deaths than HIV, tuberculosis and hepatitis combined. Yeaman and other members of the development team for NDV-3 at NovaDigm Therapeutics believe a fungal protein called Als3 can mobilize the human immune system into a multipronged attack on the pathways that allow the bacteria to take hold. In lab tests on mice, results demonstrated that it prevents and reduces the skin and blood infections, according to their December report, “Mechanisms of NDV-3 vaccine efficacy in MRSA skin versus invasive infection.” The vaccine, which is still undergoing clinical trials, is the first to target both MRSA and an associated fungus,Candida albicans, which causes infections that are also difficult to control. The two infections often occur at the same time and are growing increasingly adept at resisting anti-infective therapies.
For First Time, F.D.A. Panel Approves Generic Copy of Costly Biologic Drug
An expert panel unanimously recommended that the Food and Drug Administration approve a cheaper copy of a special drug used in cancer therapy, paving the way for alternatives to an entire class of complex and costly drugs to enter the United States market. Most brand-name drugs eventually lose their patent protection, opening the market to lower-priced generic products. But one class of drugs, known as biologics, which includes some of the most expensive medications in the world, has been insulated from the competition of cheaper copies for years. That changed when the 14 members of the panel, convened by the F.D.A., agreed to recommend approval of a drug known as EP2006, which helps the body make white blood cells and is a close copy of an existing medication called Neupogen, also called filgrastim.
Healthcare IT in 2015: What to Expect
In considering the twists and turns facing the health IT industry in 2015, it's interesting to read through others' forecasts for the coming year. For instance, InformationWeek Healthcare runs down five trends it foresees for 2015. Among those outlined are increased integration efforts due to consolidation; updated treatment guidelines in the face of new technology; increased patient engagement thanks to better tools and improved pricing transparency; IT being used to monitor training more closely; and analytics being used more to help organizations financially. Politico, meanwhile, examines the legislative agenda for health IT in 2015, breaking down its preview into six silos: FDA corrections, telemedicine, interoperability, Meaningful Use, privacy and data policies and the future of the 21st Century Cares initiative.
HHS Calls Stage 3 Rule 'Flexible, Clearer Framework'
It's more of a requisite first step than milestone, but the Department of Health and Human Services sent the proposed rule for meaningful use Stage 3 to the Office of Management and Budget. There’s precious little detail in these submissions, but HHS foreshadowed the major problems it intends to address with this next, and perhaps final, stage of the federal EHR Incentive Program. "Stage 3 will focus on improving health care outcomes and further advance interoperability," according to OMB’s website. "Stage 3 will also propose changes to the reporting period, timelines and structure of the program, including providing a single definition of meaningful use. These changes will provide a flexible, yet, clearer framework to ensure future sustainability of the EHR program and reduce confusion stemming from multiple stage requirements."
How Technology Will Eat Medicine
The most significant announcement that Apple made in 2014 wasn’t a larger-sized iPhone. It was that Apple is entering the health-care industry. With HealthKit, it is building an iTunes-like platform for health; Apple Watch is its first medical device. Apple is, however, two steps behind Google, IBM and hundreds of startups. They realized much earlier that medicine is becoming an information technology and that the trillion-dollar health-care market is ripe for disruption. Vivek Wadhwa predicts that 2015 will be the year in which tech takes baby steps in transforming medicine. The technologies that make this possible are advancing at exponential rates; their power and performance are increasing dramatically, even as their prices fall and footprints shrink. The big leaps will start to happen at around the end of this decade.
China Sending Large Ebola Relief Team to West Africa
China is ramping up its assistance in the fight against Ebola by dispatching an additional 232 army medical workers to West Africa, state media reported. The latest contingent to be sent to afflicted nations will depart with 154 of them headed to Liberia and 78 to Sierra Leone, according to the China Dailynewspaper. They will join 43 army doctors and 35 specialists from the Chinese Center for Disease Control already working in Sierra Leone, where they have treated 61 patients and trained 1,600 local medical workers.
23andMe Aims to End FDA Standoff This Year
23andMe Inc., the genetic-testing startup, is pushing to get its first agreement with U.S. regulators on a test for a disorder by this year, a turnabout after being criticized by the U.S. Food and Drug Administration for not cooperating with its approval process. The company, which scans people’s saliva to provide information on their ancestry and inherited features, hasn’t been able to include health analysis in its reports since the standoff began with the FDA in late 2013. Sales have taken a “big hit,” and the company has only recently recovered, partly by selling kits outside the U.S., Chief Executive Officer Anne Wojcicki said.
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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