News Trends Analysis

Sept. 20, 2014


World Health Organization meets to coordinate Ebola responses and strategies. The first meeting of the World Health Organization (WHO) Emergency Committee convened by the Director-General under the International Health Regulations (2005) regarding the 2014 Ebola Virus Disease outbreak in West Africa was held on August 6-7. Members of the Emergency Committee met by teleconference on both days.

Representatives of Guinea, Liberia, Sierra Leone, and Nigeria participated in the informational sessions. During those sessions, the WHO Secretariat provided an update on and assessment of the Ebola outbreak. Participants presented on recent developments in their countries, including measures taken to implement rapid control strategies, and existing gaps and challenges in the outbreak response.

After discussion and deliberation, the Committee advised that:

The Ebola outbreak in West Africa constitutes an “extraordinary event” and a public health risk to other States;

The possible consequences of further international spread are particularly serious in view of the virulence of the virus, the intensive community and health facility transmission patterns, and the weak health systems in the currently affected and most at-risk countries;

A coordinated international response is deemed essential to stop and reverse the international spread of Ebola.

It was the unanimous view of the Committee that the conditions for a Public Health Emergency of International Concern (PHEIC) have been met.

WHO: Ebola vaccine to trial next month, may be ready by 2015. As the number of deaths from Ebola hemorrhagic fever approached and passed the 1,000 mark, the World Health Organization (WHO) announced that clinical trials of a preventative vaccine for the Ebola virus made by British pharma company GlaxoSmithKline may begin this month and be made available by 2015.

“We are targeting September for the start of clinical trials, first in the United States and certainly in African countries,” Jean-Marie Okwo Bele, the WHO’s head of vaccines and immunization, told French radio. He said he was optimistic about making the vaccine commercially available. “We think that if we start in September, we could already have results by the end of the year….Since this is an emergency, we can put emergency procedures in place…so that we can have a vaccine available by 2015.”


PALB2 gene increases risk of breast cancer dramatically. Research published in the New England Journal of Medicine provides evidence that another gene besides the BRCA 1/2 genes is associated with increased risk of breast cancer. Women with mutations in the PALB2 gene have on average a one-in-three chance of developing breast cancer by the age of seventy.

In a study run through the international PALB2 Interest Group a team of researchers from 17 centers in eight countries, led by the University of Cambridge, analyzed data from 154 families without BRCA1 or BRCA2 mutations. The study included 362 family members with PALB2 gene mutations. Women who carried rare mutations in PALB2 were found to have on average a 35% chance of developing breast cancer by the age of seventy. However, the risks were highly dependent on family history of breast cancer; carriers with more relatives affected by breast cancer were at higher risk. Only a very small proportion of women worldwide carry such mutations, and the researchers point out that additional studies are required to obtain precise estimates of mutation carrier frequency in the population.

PALB2 is known to interact with both the BRCA1 and BRCA2 mutations and was first linked with breast cancer in 2007. As is the case for women who carry mutations in BRCA1 or BRCA2, women with PALB2 mutations who were born more recently tended to be at a higher risk of developing breast cancer than those born earlier. The reason is unclear, but the researchers speculate that it may be related to factors such as later age at first childbirth, smaller families, and better surveillance leading to earlier age of diagnosis. 

Blood and saliva tests help predict return of HPV-linked oral cancers. Physicians at Johns Hopkins have developed blood and saliva tests that help accurately predict recurrences of HPV-linked oral cancers in a substantial number of patients. The tests screen for DNA fragments of the human papillomavirus (HPV) shed from cancer cells lingering in the mouth or other parts of the body. A description of the development was published in JAMA Otolaryngology—Head & Neck Surgery.

The Johns Hopkins team analyzed blood and saliva samples from 93 oropharyngeal cancer patients who were treated with surgery, radiation alone, or combined chemotherapy and radiation at The Johns Hopkins Hospital or Greater Baltimore Medical Center. Samples were collected before and after treatment. Eighty-one patients had HPV-positive tumors. The researchers selected patients with a variety of early-to-advanced stage cancers; none of the patients had distant metastasis. 

The blood and saliva tests were performed using polymerase chain reaction. The scientists found that HPV DNA detected in patients’ saliva after treatment was predictive for recurrence nearly 20% of the time in a subset of the patients. When the scientists looked for HPV DNA in the blood of another subset of patients, the accuracy of a recurrence prediction rose to more than 55%. In a third subset, finding HPV DNA in both blood and saliva samples after treatment accurately predicted recurrence 70% of the time.

New cancer classification system might boost patient outcomes. Changes in the way cancers are classified could lead to more accurate diagnoses and perhaps more effective treatments in about one in 10 cancer patients, new research suggests. Typically, cancers are categorized according to the tissue in which they originated, such as breast, bladder, or kidney cancer. But tissues are composed of different types of cells. 

In this study, researchers who analyzed more than 3,500 tumor samples of 12 different cancer types concluded that defining tumors by their cellular and molecular features, rather than by the tissues in which they originated, would improve diagnoses in about 10 percent of cancer cases. 

“This genomic study not only challenges our existing system of classifying cancers based on tissue type, but also provides a massive new data resource for further exploration, as well as a comprehensive list of the molecular features distinguishing each of the newly described cancer classes,” study co-senior author Christopher Benz,  MD, professor at the Buck Institute for Research on Aging at the University of California, San Francisco, said in a university news release.  The study, published in the journal Cell, is part of The Cancer Genome Atlas initiative, which is led by the U.S. National Cancer Institute and U.S. National Human Genome Research Institute. 

The researchers report particularly significant findings in bladder and breast cancers. They identified at least three different subtypes of bladder cancer, including one that was nearly identical to a form of non-small cell lung cancer called lung adenocarcinoma, and another most similar to squamous-cell cancers of the head and neck and of the lungs.

The researchers confirmed known differences between two forms of breast cancers called basal-like and luminal. But they also discovered that these differences are significant and that basal-like breast cancers—commonly referred to as triple-negative—are a distinct class of tumor. 

Further research could reveal that as many as 30 percent to 50 percent of cancers need to be reclassified, according to Benz. 

Industry News

FDA takes steps to help ensure the reliability of certain diagnostic tests. The U.S. Food and Drug Administration (FDA) recently took important steps to ensure that certain tests used by healthcare professionals to help diagnose and treat patients provide accurate, consistent, and reliable results.

First, the FDA issued a final guidance on the development, review, and approval or clearance of companion diagnostics, which are tests used to identify patients who will benefit from or be harmed by treatment with a certain drug. Companion diagnostic tests are intended to aid physicians in selecting appropriate therapies for individual patients. These tests are commonly used to detect certain types of gene-based cancers.

Second, consistent with the requirements of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), the agency is notifying Congress of its intention to publish a proposed risk-based oversight framework for laboratory developed tests (LDTs), which are designed, manufactured, and used within a single laboratory. They include some genetic tests and tests that are used by healthcare professionals to guide medical treatment for their patients. The FDA already oversees direct-to-consumer tests regardless of whether they are LDTs or traditional diagnostics.

The companion diagnostics guidance is intended to help companies identify the need for these tests during the earliest stages of drug development and to plan for the development of a drug and a companion test at the same time. The ultimate goal of the final guidance is to stimulate early collaborations that will result in faster access to promising new treatments for patients living with serious and life-threatening diseases. This guidance finalizes and takes into consideration public comment on the draft guidance issued in 2011.

While the FDA has historically exercised enforcement discretion over LDTs (generally not enforced applicable regulatory requirements), today these tests may compete with FDA-approved tests without clinical studies to support their use. The LDT notification to Congress provides the anticipated details of the draft guidance through which the agency would propose to establish an LDT oversight framework, including pre-market review for higher-risk LDTs, such as those that have the same intended use as FDA-approved or cleared companion diagnostics currently on the market. The draft guidance would also propose to phase in enforcement of pre-market review for other high-risk and moderate-risk LDTs over time.

The agency intends to propose continuing to exercise enforcement discretion for low-risk LDTs, LDTs for rare diseases, and, under certain circumstances, LDTs for which there is no FDA-approved or cleared test.

The FDA also intends to publish a draft guidance outlining how laboratories can notify the FDA that they are currently manufacturing and using LDTs, how to provide information about their LDTs, and how they can comply with the medical device reporting requirements.

Cerner to acquire Siemens Health Services. Cerner Corporation and Siemens AG  announced a definitive agreement for Cerner to acquire the assets of Siemens’ health information technology business unit, Siemens Health Services, for $1.3 billion. As part of the agreement, Cerner and Siemens will form a strategic alliance to bring new solutions to the market that combine Cerner’s health IT leadership and Siemens’ strengths in medical devices and imaging. Cerner and Siemens will jointly invest in innovative projects that integrate health IT with medical technologies for the purpose of enhancing workflows and improving clinical outcomes. Advanced workflows, along with medical images and their role in diagnostic and therapeutic decision-making, will be an early focus of the joint work. 

Infection Control

C. diff to be treated with “bacteria-eating viruses.” The potentially fatal Clostridium difficile bacterium is a serious problem in hospitals due to its resistance to antibiotics. However, a team of scientists from the European Molecular Biology Laboratory in Hamburg, Germany, may have found a new way to treat these difficult bacteria—by using viruses to “eat” them.

Viruses called bacteriophages infect only bacteria, using the bacteria’s own DNA-reading machinery to duplicate themselves and destroy the bacteria’s cell walls. Breaking down these walls causes the bacteria to explode, allowing the bacteriophages to burst out and find new bacteria to attack.

Rob Meijers, from the European Molecular Biology Laboratory (EMBL), led the research and believes that the study could have far-reaching implications: “Our findings will help us to engineer effective, specific bacteriophages, not just for C. diff infections, but for a wide range of bacteria related to human health, agriculture, and the food industry.”

In order to use bacteriophages, scientists have needed to find out how precisely the viruses destroy cell walls. The parts of the virus that accomplish this, the endolysins, were already known, but only now have scientists discovered how they are activated.

The authors of the study, published in PLOS Pathogens, were able to discover the switch from one conformation to the other by working out the 3D structure of the endolysins using X-ray crystallography and small angle X-ray scattering.

The activation mechanism was found to be shared by both the species of Clostridium-targeting bacteriophages, leading the team to conclude that this is likely to be a common feature and could be harnessed in order to use other viruses to attack antibiotic-resistant bacteria.

If the discovery of this structural switch enables scientists to engineer viruses as an alternative to antibiotics, then it could spell the end for healthcare-associated infections such as C. diff, which remains at historically high levels and is responsible for 14,000 deaths linked to diarrhea each year.