viernes, 9 de enero de 2015



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

January 08, 2015

News Highlights

  • This Season’s Flu Activity Has Reached the Epidemic Threshold, the CDC Says
  • CDC Director Warns Against Ebola Complacency
  • UN: Ebola Kills 8,153 People in West Africa, Infects 20,650
  • CLSI Releases an Updated Standard on Nongynecological Cytology Specimens
  • New Measure of HDL Cholesterol Function
  • First Newborn Screening Test Approved for Rare Immune Disorder
  • Research Suggests Vitamin D Could Affect Brain Function
  • Chronic High Blood Sugar may be Detrimental to the Developing Brain of Young Children
  • New HIV Guideline Updates, Expands Prevention Recommendations
  • Does Chilly Weather Really Cause a Cold?
  • App Tracks Ebola Survivors for Public Health
  • 4 Ways Consumers Will Impact HIT in 2015
  • Study: Nearly Half of Patients Would Withhold Data From Providers

View Previous Issues - Healthcare News Archive

Leading News

This Season’s Flu Activity Has Reached the Epidemic Threshold, the CDC Says
This year's flu season has officially crossed the epidemic threshold, according to the Centers for Disease Control and Prevention. Fifteen children have died across the country from influenza, as the number of states reporting a "high" level of influenza activity jumped from 13 to 22 in one week. The determination follows an earlier warning from the agency that this year's flu season could be a severe one. Keep in mind, however, that epidemic-levels of flu activity in the U.S. are a typical part of the annual flu season. In other words, it's simply too early to determine just how severe this year's epidemic will be. The CDC uses several methods to track and characterize the outbreak. "Right now, all of the CDC's influenza surveillance systems are showing elevated activity," The CDC's flu division said in an e-mailed statement. The influenza season reaches an epidemic level when the proportion of deaths attributed to pneumonia and influenza reaches a certain threshold: 6.8 percent. According to the CDC's latest available information on the flu season,the percentage is currently at the threshold.
CDC Director Warns Against Ebola Complacency
The number of Ebola cases in West Africa has not reached worst-case scenario predictions, but until it drops to zero, the world remains at risk, the CDC director said. Speaking to reporters after a visit to Liberia, Guinea and Sierra Leone, Centers for Disease Prevention Director Dr. Tom Frieden said he saw "real momentum and real progress" in combating the virus. "It's going to be a long hard fight, but I am hopeful that we are going to see continued progress. The challenge is not to let up, not to be complacent and to really double down," he said.
UN: Ebola Kills 8,153 People in West Africa, Infects 20,650
The World Health Organization says at least 8,153 people have died in the Ebola outbreak in West Africa.  The Geneva-based body said that the total number of confirmed, probable and suspected deaths from the disease comes from 20,656 cases in the three most affected countries - a mortality rate of 39 percent. The U.N. health agency says 2,915 deaths have been reported from Sierra Leone, 3,471 in Liberia and 1,767 in Guinea. The current outbreak, which began about a year ago, has also claimed more than dozen lives elsewhere.
New Hope as DNA Vaccines to Fight Ebola Proved Safe
Two experimental DNA vaccines to prevent Ebola are safe, according to new research. The findings from the first trial of filovirus vaccines in Africa, published in the Lancet, show they generated a similar immune response in healthy Ugandan adults as reported in healthy American adults earlier. Now it is hoped the vaccines can help to contain outbreaks of the Ebola virus and the closely related Marburg virus. Lead author Doctor Julie Ledgerwood, of the National Institutes of Allergy and Infectious Diseases (NIAID) in the US, said: “This is the first study to show comparable safety and immune response of an experimental Ebola vaccine in an African population. “This is particularly encouraging because those at greatest risk of Ebola live primarily in Africa, and diminished vaccine protection in African populations has been seen for other diseases.” Scientists from the NIAID developed the DNA vaccines coded for Ebola virus proteins from Zaire and Sudan strains and the Marburg virus protein.
Source of Ebola Outbreak in West Africa Might be Bats, Study Says
The toddler in Guinea who is thought to have been the first case in the current outbreak of Ebola in West Africa may have caught the virus from bats in a hollow tree near his village, scientists said. A study, led by scientists from the Robert Koch Institute in Berlin and published online by the journal EMBO Molecular Medicine, could not prove the link because the tree in Meliandou, a village of 31 houses in the Guéckédou district, burned in late March and the bats inside were immolated or flew off. The fire took place shortly after Guineans were warned that the virus might come from bats. By then, at least 10 local people were dead. However, the scientists found enough residual DNA in the charred trunk and fecal DNA in nearby soil to identify the animals as Mops condylurus, long-tailed insect-eating bats that were previously suspected in an outbreak of the Sudan strain of Ebola virus, which is related to the Zaire strain that has infected over 20,000 West Africans. The study is important because scientists have wondered how a boy named Emile Ouamouno, who died in December 2013 and whom various reports describe as 1 or 2 years old, could have been the index patient.

Laboratory Testing / Diagnostics

CLSI Releases an Updated Standard on Nongynecological Cytology Specimens
The Clinical and Laboratory Standards Institute (CLSI) has released an updated document, Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline—Second Edition (GP23-A2).  “GP23-A2 includes numerous changes to reflect current technology. We added a large section on quality control practices that any laboratory may easily incorporate to provide a comprehensive quality assurance program,” highlighted MariBeth Gagnon, MS, CT (ASCP) HTL, Chairholder of the Document Development Committee on Nongynecologic Cytologic Specimens, Cytotechnologist, Centers for Disease Control and Prevention, Atlanta, Georgia, USA. This edition aligns the standard with new technology and best practices that have come about since its last publication in 1999.
Labs Ramp Up for Ebola Patients, Specimens
Clinical laboratories have made impressive headway in their Ebola preparedness, though their plans are shaping up in different ways. That’s due, in part, to varying opinions about how to manage a dangerous and unpredictable virus. “We are really learning as we go along with this,” says D. Jane Hata, PhD, D (ABMM), director of microbiology and serology at Mayo Clinic in Jacksonville, Fla. For years there has been talk of the possibility of an airplane passenger bringing Ebola into the U.S., she says. “But we are on the ground now and we’re all actively planning to deal with this.” Above all, says Cleveland Clinic’s Gary W. Procop, MD, MS, institutions need a procedure to determine if a patient meets the Centers for Disease Control and Prevention’s criteria for a person under investigation (PUI) for Ebola. Two experienced physicians, one of whom should have infectious diseases training, should make that assessment, says Dr. Procop, an infectious disease pathologist and microbiologist and chair of the CAP’s Microbiology Resource Committee. (The CDC describes the PUI criteria at
New Measure of HDL Cholesterol Function
Study shows cholesterol efflux seems to be better at predicting cardiovascular risk.
Cholesterol efflux capacity—a measure of cholesterol function—is a better indicator of a person’s cardiovascular risk, and it’s a better target for treatments than long-used standard high-density lipoprotein (HDL) cholesterol measurements, reports a groundbreaking study recently published inThe New England Journal of Medicine. Researchers from UT Southwestern Medical Center in Dallas, Emory University in Atlanta, and the Perelman School of Medicine at the University of Pennsylvania in Philadelphia measured cholesterol efflux in more than 3,000 study participants taking part in the Dallas Heart Study. The results showed a “significant protective relationship between cholesterol efflux and cardiovascular risk,” according to a press release. “The better a person’s cholesterol efflux, the less likely he or she was to suffer a heart attack, stroke, or death from heart disease,” and the association was stronger for cholesterol efflux than for standard HDL measurements.
First Newborn Screening Test Approved for Rare Immune Disorder
The first test to screen for Severe Combined Immunodeficiency (SCID) in newborns has been approved by the U.S. Food and Drug Administration. Some 40 to 100 cases of SCID are identified each year among newborns in the United States, the federal Centers for Disease Control and Prevention says. The group of disorders is caused by genetic defects that influence infection-fighting immune cells. While babies with SCID appear normal at birth, they typically develop deadly infections within a few months, the FDA said in a news release. Death commonly occurs during the infant's first year without early detection and treatment.
Presepsin an Accurate Biomarker for Late-Onset Sepsis in Preemies
Presepsin (P-SEP) appears to be an accurate biomarker of late-onset sepsis in premature infants and might help in monitoring response to treatment, report clinicians from Italy. Late-onset sepsis (LOS) is a leading cause of illness and death in preterm newborns, and better diagnostic tools are needed. P-SEP, a trunked portion of soluble CD14, is released by various immune cells including macrophages, monocytes, and neutrophils, when stimulated by pathogens. P-SEP has recently been shown to be a reliable diagnostic and prognostic marker of sepsis in adults.
Roche Expands use of Next-Gen Blood Tests for Organ and Tissue Screening
Roche got a green light from U.S. regulatory authorities to expand the use of two tests from its cobas assay line used to detect serious viral infections like HIV, hepatitis B and C and West Nile virus (WNV). The Swiss company said its cobas MPX and cobas WNV assays can now be used for testing of human organ and tissue from cadavers in markets where the tests have a CE mark. The new claims allow for pre-implantation screening of organ and tissue donations so transplant recipients don't receive infected blood.
Portable Lens-Free Holographic Microscopy Brings Pathology Lab Anywhere
The lab of Dr. Aydogan Ozcan at UCLA seems like an ever-flowing wellspring of new optical gadgets that can be used in biomedical applications. A new study published by the researchers in Science Translational Medicine describing a new lens-free microscopy technique that allows for wide-field viewing of pathology slides using a small, cheap, and portable device. The device creates a holographically reconstructed image the objects within which can be brought into focus at any depth following the image capture. Unlike normal optical microscopes, this does not require any mechanical components to move the lens, making image capture nearly automatic.
Massachusetts Commits $1M to Fund R&D for Disposable Ebola Test
The Massachusetts Life Sciences Center announced a $1 million challenge grant to fund research and development for a rapid, disposable, molecular diagnostic test for the Ebola virus. The grant will support a partnership of firms, non-governmental organizations, and academic institutions. The partnership is led by Diagnostics For All and includes Harvard University, the Broad Institute, the University of Massachusetts Medical School, GE Healthcare, Cambridge Consultants, Eiken, BBI Solutions, Impact Technology Development, and Sierra Leone's WellBody Alliance. Under the terms of the award, the partners will seek to raise an additional $4.5 million. The grant will support work on an Ebola molecular diagnostic test that incorporates isothermal nucleic acid amplification on a paper substrate. The device is being designed to generate results from a single finger-prick of blood, and to provide a clear positive or negative response in 45 minutes. It will not require the use of laboratory equipment and could be available for testing in six months.

Research and Development

Research Suggests Vitamin D Could Affect Brain Function
When you think of vitamin D, you may think of bone health. For years, doctors have recommended vitamin D and calcium supplements to guard against fractures and osteoporosis. But in recent years, the efficacy of those supplements has been widely questioned, while other research has explored possible connections between vitamin D and heart health, cancer prevention, and other health benefits. Those connections have not yet been proved, but now studies on the relationship between vitamin D and serotonin production are taking researchers down a new path. A growing body of evidence suggests that vitamin D — present in some foods and produced naturally when skin is exposed to sunlight — regulates the enzyme that converts the amino acid tryptophan into serotonin, a neurotransmitter believed to help regulate moods and direct brain development while in the womb. Patrick, a postdoctoral fellow at Children’s Hospital Oakland Research Institute in Oakland, Calif., said the degree to which vitamin D regulates serotonin isn’t yet clear. But psychologists and neuroscientists have established the effects of low serotonin by restricting tryptophan entering the brains of human test subjects, she said.
Chronic High Blood Sugar may be Detrimental to the Developing Brain of Young Children
NIH study shows young children with type 1 diabetes have significant difference in brain development. Young children who have long-term high blood sugar levels are more likely to have slower brain growth, according to researchers at centers including the National Institutes of Health. Researchers did not find significant cognitive differences between the healthy children and those with type 1 diabetes, but they believe a continuing study with the same groups of children may show changes there as well. The findings could lead to a major shift in the way children with type 1diabetes are treated, said Dr. Karen Winer, a co-author of the study and a pediatric endocrinologist at the NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which co-funded the 18-month study. The findings were published online in the journal Diabetes. New technology allows doctors to monitor blood sugar levels quickly, accurately and continuously. This technology is more accessible than before, and doctors can anticipate lower blood sugar levels and deal with them proactively, she said.
Some Blood Types Might Raise Type 2 Diabetes Risk: Study
In what scientists say is a first, a new analysis suggests that some blood types place women at a higher risk for developing type 2 diabetes. How much higher? According to a team of French researchers, women with blood type B positive appear to face a 35 percent greater risk for developing type 2 diabetes than women with blood type O negative. However, experts questioned the value of the findings when so many other risk factors for the blood sugar disease can be countered with lifestyle changes. At play in the study was the basic principal that, as the American Red Cross notes, "not all blood is alike."
NHS DNA Scheme to Fight Cancer and Genetic Diseases
A new genetics project could help "unlock a series of secrets about devastating diseases", the NHS says. Under the scheme, 11 Genomics Medicine Centres are being set up in English hospitals to gather DNA samples to help devise targeted treatments for a wide range of diseases. It is focusing on cancer and rare genetic diseases.  The aim is to sequence 100,000 genomes within three years in order to develop new tests and drugs. Doctors will offer suitable patients the opportunity to take part in the scheme. They will have to agree to have their genetic code and medical records - stripped of anything that could identify them - made available to drugs companies and researchers. Up to 25,000 cancer patients will have the genetic code of their healthy tissue compared to the genetic code of their tumour. A giant game of spot-the-difference will then take place to identify the precise mutations in DNA that are causing a patient's tumour. This would allow targeted medicines to be developed.
Could Bacteria Play a Role in Colon Cancer?
Dense bunches of bacteria called biofilms can be found on most colon polyps and cancers, a new study finds. The researchers said these biofilms were especially prevalent on the right side of the colon. The presence of these biofilms may represent an increased likelihood of colon cancer and could offer a new way to predict a person's risk for the disease, the researchers said. Like tooth plaque and slime on pond stones, these biofilms may coat the mucus layer of cells lining the colon, according to background information from the study. There, the biofilms may cause inflammation and some noncancerous bowel diseases, said Dr. Cynthia Sears, professor of medicine and oncology at the Johns Hopkins University School of Medicine and Bloomberg School of Public Health. The researchers examined healthy and cancerous tissue collected during biopsies on almost 120 people. Biofilms were present on 89 percent of tumors removed from the right colon, according to the researchers. Biofilms were found on only 12 percent of tumors removed from the left side of the colon. The reasons for the difference between the right and left side of the colon are unknown, the researchers said.
Crohn's, Colitis May Have Genetic Underpinnings, Study Finds
The intestinal bacteria that cause inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, may be inherited, researchers report. The findings, published recently in the journal Genome Medicine, could help in efforts to prevent the disease and treat the 1.6 million Americans with Crohn's or colitis, the study authors added. "The intestinal bacteria, or 'gut microbiome,' you develop at a very young age can have a big impact on your health for the rest of your life," lead author Dan Knights, an assistant professor in the department of computer science and engineering and the Biotechnology Institute at the University of Minnesota, said in a journal news release.
Ability to Culture 'organoids' set to Transform Pancreatic Cancer Research
A new 3D "organoid" culture system for growing both normal and cancerous pancreatic cells in the lab promises to transform research on pancreatic cancer and the development of new personalized treatments. The potential to use organoids is a game changer for pancreatic cancer research. It means researchers can grow 3D tissue made entirely of ductal cells, uncontaminated by the other types of cell that normally accompany them when retrieved from samples. Co-lead author Dr. Chang-Il Hwang, who works in Prof. Tuveson's group at CSHL, says, "We now have a model for each stage in the progression of the disease." Another advantage the new technique brings is to broaden the scope of patients from whom pancreatic tissue can be obtained.
GRP78 Protein Acts as Universal Therapeutic Target for Infections and Cancer
A research team led by scientists at Virginia Commonwealth University reports that a protein called GRP78 could be a universal therapeutic target for treating human diseases such as brain cancer, Ebola, Influenza, hepatitis, and superbug bacteria such as MRSE and MRSA. The preclinical study, “GRP78/BiP/HSPA5/Dna K is a universal therapeutic target for human disease”, is published in the Journal of Cellular Physiology. By using a drug combination of the clinically tested OSU-03012 (AR-12) and FDA-approved Phosphodiesterase 5 Inhibitors (Viagra, Cialis) to target GRP78 and related proteins, researchers prevented the replication of a variety of major viruses in infected cells, made antibiotic-resistant bacteria vulnerable to common antibiotics and found evidence that brain cancer stem cells were killed. Data were obtained in multiple brain cancer stem cell types, and using Influenza, Mumps, Measles, Rubella, RSV, CMV, Adenovirus, Coxsakie virus, Chikungunya, Ebola, Hepatitis, E. coli, MRSA, MRSE, and N. gonorrhoeae, among others.

Public Health and Patient Safety

New HIV Guideline Updates, Expands Prevention Recommendations
A new guideline containing updated and new recommendations on preventing HIV transmission is available for clinical providers, nonclinical providers, and health department staff members. The Centers for Disease Control and Prevention (CDC) published the comprehensive guideline, "Recommendations for HIV Prevention With Adults and Adolescents With HIV in the United States, 2014," on December 12, along with a summary for clinical providers. Summaries also are available for nonclinical providers and health department staff members. "Several factors have prompted this update: the context and method of HIV prevention, care, and treatment is changing in the US due to recent advances in biomedical, behavioral, and structural prevention strategies, changes in public and private sector healthcare delivery, and new national HIV prevention strategies," Kathleen Irwin, MD, MPH, a medical epidemiologist in CDC's Division of HIV/AIDS Prevention, and a primary author of the guideline, told Medscape Medical Newsthrough a spokesperson.
Does Chilly Weather Really Cause a Cold?
A new study by Yale researchers suggests that cool temperatures can play a role in causing the common cold, by inhibiting the virus-fighting ability of cells in the nose. It's a commonly held belief that catching a chill can bring on a nasty cold. However, researchers have long argued the point, noting that people can transmit and catch cold viruses year round. Now, in a paper published in the journal PNAS, a team of researchers studying mice has concluded that most rhinoviruses reproduce more efficiently at temperatures slightly lower than body temperature, or 98.6 degrees.
UPDATE 1-FDA Allows Testing of Aethlon Device in Ebola Patients
Aethlon Medical Inc said the U.S. Food and Drug Administration had approved the testing in Ebola patients of its bio-filtration device, which was used against the deadly virus in a critically ill patient in Germany who later recovered. The device, being developed as a broad-spectrum countermeasure against pandemic threats, filters viruses and toxins from the blood. It is currently being tested in India for its ability to accelerate viral load depletion when used in combination with hepatitis C standard-of-care drug therapy. Patients will be treated for six to eight hours daily with the device, called Aethlon's Hemopurifier, until the Ebola viral load drops below 1,000 copies/ml.
Cancer’s Random Assault
It may sound flippant to say that many cases of cancer are caused by bad luck, but that is what two scientists suggested in an article published in the journal Science. The bad luck comes in the form of random genetic mistakes, or mutations, that happen when healthy cells divide. Random mutations may account for two-thirds of the risk of getting many types of cancer, leaving the usual suspects — heredity and environmental factors — to account for only one-third, say the authors, Cristian Tomasetti and Dr. Bert Vogelstein, of Johns Hopkins University School of Medicine. “We do think this is a fundamental mechanism, and this is the first time there’s been a measure of it,” said Dr. Tomasetti, an applied mathematician.

Health IT

App Tracks Ebola Survivors for Public Health
What can public health officials learn from those people who have been infected with and survived Ebola? Plenty, they're hoping. And a new interactive app enables survivors to share their stories and to connect with others in what health officials are optimistic will help control spreading of the deadly disease, primarily in western Africa but also globally, Government Health IT sister site mHealth News reported. To start things off, each survivor in Guinea, Sierra Leone and Liberia willing to share his or her story is given a smartphone pre-loaded with the app, dubbed #ISurvivedEbola. The app, part of the #TackleEbola campaign launched in December, syncs into a web site wherein survivors can connect with each other and learn about challenges still ahead.
4 Ways Consumers Will Impact HIT in 2015
It's hard to deny the influence patients as consumers are having on the healthcare industry, and many predict that 2015 will be the year of the consumer. When it comes to health technology, consumers and providers of care are in parallel universes, but next year the industry will see "consumers, patients and caregivers pressure providers to converge toward greater convenience, access, transparency and quality using health IT," according to Jane Sarasohn-Kahn, a health economist and management consultant, writing at iHealthBeat. Four of the changes patients will cause to happen in 2015, according to Sarasohn-Kahn, include:
1.         Healthcare embraces do-it-yourself
2.         Employers play a role in wearable use
3.         Telemedicine will expand
4.         Social and consumer-generated data growth
Study: Nearly Half of Patients Would Withhold Data From Providers
Nearly half of patients participating in a trial looking at patient control of the medical records withheld clinically sensitive information from some or all of their care team. The Regenstrief Institute, Indiana University School of Medicine and Eskenazi Health (formerly Wishard Health Services) conducted the six-month trial involving 105 patients at a primary care clinic. Patients were allowed to designate who could see their records, including information on sexually transmitted diseases, substance abuse or mental health. Patients were able to hide some or all of their data from some or all providers--and 49 percent of them did. However, healthcare providers were able to view the hidden data, if they felt the patient's healthcare required it, by hitting a "break the glass" button on their computer screens, according to an announcement. While patients strongly favored control over their records, providers had mixed reactions. In the trial, 54 percent of providers said patients should be able to control who can see their electronic health record data; 58 percent said restricting providers' access could be harmful to the patient-physician relationship; and 71 percent said withholding data in the EHR would have a negative impact on the quality of care.
Telemedicine Market to Nearly Double Over Next 5 Years
A focus on health IT and mobile healthcare will lead the global telemedicine market to nearly double in five years, according to a new industry research report. The market will see growth at 18.88 percent CAGR, from 2014 to 2019, according to "While all the major players in the market are focusing on R&D to launch innovative products and services, there is also a sense of urgency among vendors regarding the need to improve bandwidth and enhance the reach of mobile health," according to an announcement on the report. Currently, issues such as reimbursement for services and licensing are holding the telemedicine market back. According to the report, though, players in the market are focusing their attention on the cost pressures and taking an interesting in developing guidelines for the services.
CLSI Releases an Updated Standard on Information Technology Security
The Clinical and Laboratory Standards Institute (CLSI) has released an updated document, Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard—Second Edition (AUTO11-A2). This document provides a framework for communication of information technology security issues between the in vitro diagnostic (IVD) system vendor and the health care organization. The second edition of this standard includes an increased emphasis on computer, or cyber, security within the health care system. This edition of AUTO11 aligns the standard with new technology and best practices that have emerged since the last publication in 2006.
ICD-10 Testing: CMS Announces Dates, Pubs Guidance
A new ICD-10 end-to-end testing period for providers, as well as associated guidance for testing, was revealed by the Centers for Medicare & Medicaid Services. The new testing period, which will involve a second sample group of providers, according to CMS, will run from April 26, 2015, through May 1, 2015; other testing dates include Jan. 26-30, 2015, and July 20-24, 2015. A total of 850 volunteer submitters will participate in the April testing, which also will include claims clearinghouses that submit claims for multiple providers. The goal of the testing, CMS says, is threefold:
  • To ensure that providers can submit claims with ICD-10 codes to Medicare
  • To ensure that CMS' software changes result in properly adjudicated claims
  • To ensure the creation of accurate remittance advices
Providers who wish to volunteer must fill out a form--available on their Medicare Administrative Contractor's (MAC) website--by Jan. 9, 2015. The guidance gives providers, clearinghouses and others advice for preparing their test claims, and explains the difference between end-to-end testing and previously announced acknowledgement testing.
Study: Time to Re-evaluate Policies on Patient Access to PHI
Even as healthcare providers embrace electronic health records, it's time they re-evaluated their policies for providing patients with access to their medical records, according to research published at Perspectives on Health Information Management. The research is based on survey responses of 313 members of the American Health Information Management Association. Despite the adoption of EHRs and portals through which patients can view their records, many organizations still charge patients for that access. In fact, 52.6 percent of respondents said they charge patients for electronic copies of their medical records--such as via a flash drive or DVD--and 64.7 percent charge patients for paper copies. Charges for paper copies generally were by page, with 65 percent reporting that they charge less than $1 per page.

Other News

Myriad Loses Appeals Court Bid to Block Breast Cancer Tests
Myriad Genetics Inc. (MYGN) can’t block competitors’ DNA tests to determine risk for breast and ovarian cancer after a U.S. appeals court said three patents on the tests never should have been issued. The patents cover products of nature and ideas that aren’t eligible for legal protection, the U.S. Court of Appeals for the Federal Circuit said in an opinion posted on the court’s docket. The court upheld a trial judge’s decision to allow the competing tests, including those made by Ambry Genetics Corp., to remain on the market.
EU's Top Court Opens Door to Some Stem Cell Patents
Europe's top court has opened the door to certain stem cell patents in the European Union by ruling that an organism incapable of developing into a human being is not a human embryo and may be patented. This judgment by the European Court of Justice was made following a case brought in Britain by U.S. company International Stem Cell Corporation over whether it could patent processes covering the use of human egg cells. The case is significant because three years ago the EU court ruled that stem cell research involving human embryos could not be patented, a decision condemned at the time by some scientists as a "devastating" blow for medical research in Europe.

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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