News Trends Analysis

June 19, 2014

News

Two Middle East Respiratory Syndrome coronavirus infections (MERS-CoV) have been confirmed in United States; test kits have been distributed to labs. In late April, MERS-CoV was confirmed by the Centers for Disease Control and Prevention (CDC) in a traveler to the U.S. On April 24, the patient traveled by plane from Saudi Arabia to London, and then from London to Chicago. The patient then took a bus from Chicago to Indiana. On April 27, the patient began to experience respiratory symptoms, including shortness of breath, coughing, and fever. The patient went to an ED in an Indiana hospital April 28 and was admitted that day. The patient was cared for in an air-handling and ventilation isolation room, and was released from the hospital May 9. 

CDC test kits were deployed via the Laboratory Response Network (LRN). Forty-five public health laboratories—44 state laboratories and one large local laboratory—have the test kit and are prepared to perform testing. Six states cannot conduct the test because they do not have one of the requisite extraction platforms (EasyMag or MagNA Pure). CDC will provide testing for suspect cases in those states. Public health labs are to report all cases to CDC and forward specimens to CDC for confirmatory testing.

The MERS-CoV test, developed by CDC, is a real-time reverse transcription polymerase chain reaction (real-time RT-PCR) assay, which combines qualitative and quantitative measures to detect RNA expression levels in real time (i.e., qualitative and quantitative measurement is conducted simultaneously). The test quantifies the number of copies of viral RNA per given volume of a specimen (generally measured in microliters). It is considered the optimal test for detection of RNA levels.

As this issue of MLO goes to press, a second MERS patient has been identified  in Orlando, FL. This patient also came to the U.S. from Saudi Arabia via London, but the CDC says this case is not linked to the first.

Infectious Disease

A study published online in Current Biology contains sobering indications that antibiotic-resistant genes may be more prevalent in nature than has been previously recognized. The research, conducted by scientists at the University of Lyon in France, centered on the comparison of DNA samples found in naturally occurring environments to those of so-called “superbugs” isolated from hospital patients. More than 70 environments were found to harbor antibiotic-resistant genes—”from Antarctic lakes to forest soil in Puerto Rico to the guts of mice,” as the Washington Post put it.

Says Joseph Nesme, one of the study authors: “While the environment is known to harbor antibiotic-resistant strains of bacteria, we did not really know the extent of their abundance.” The study summary elaborates: “Antibiotic resistance genes were found in environmental isolates, soil DNA, secluded caves, and permafrost DNA…Using metagenomic sequences, we show that antibiotic resistance gene determinants (ARGDs) can be detected in all (n=71) environments analyzed. The most common types of resistances found in environmental metagenomes were efflux pumps and genes conferring resistance to vancomycin, tetracycline, or ß-lactam antibiotics.” 

Organizations

COLA’s 2014 Leadership Summit serves as a forum for a valuable exchange of ideas. The accreditor of medical laboratories COLA successfully concluded its 2014 Leadership Summit recently. More than 30 thought leaders in healthcare, including physicians, regulators, public health experts, medical laboratory scientists, manufacturers, nurse practitioners, and others convened in San Francisco to discuss the future of laboratory medicine in the context of the Affordable Care Act (ACA).The group explored the implications of the dynamics of ACA and changing payment policies on quality and learning in laboratory medicine.

Participants engaged in smaller multi-disciplinary groups to explore questions central to the current state of laboratory medicine. They also considered a possible future direction related to the true value of laboratory medicine within healthcare and their vision for continuous quality and learning. Finally, the group suggested possible action items.

Among the topics discussed were the impact of indiscriminate payment reductions in laboratory medicine; the need to provide physician education related to laboratory utilization; the shortage of laboratory professionals and how technology will change the vocation; required job skills in the future; continuing education models; organizational barriers to quality and learning; and the role of oversight. 

“By bringing together leaders across professional disciplines to discuss the role of laboratory medicine, we were able to better appreciate the complexity of the context and to set a broader direction grounded in the reality of real world dynamics,” says Doug Beigel, CEO of COLA. 

Cancer

NCI study demonstrates that a new cancer immunotherapy method could be effective against a wide range of cancers. A new method for using immunotherapy to specifically attack tumor cells that have mutations unique to a patient’s cancer has been developed by scientists at the National Cancer Institute. The researchers demonstrated that the human immune system can mount a response against mutant proteins expressed by cancers that arise in epithelial cells which can line the internal and external surfaces of the body. These cells give rise to many types of common cancers. The research provides evidence that this immune response can be harnessed for therapeutic benefit.

All malignant tumors harbor genetic alterations, some of which may lead to the production of mutant proteins that are capable of triggering an antitumor immune response. Prior research had shown that human melanoma tumors often contain mutation-reactive immune cells called tumor-infiltrating lymphocytes (TILs). The presence of these cells may help explain the effectiveness of adoptive cell therapy (ACT) and other forms of immunotherapy in treatment.

In ACT, a patient’s own TILs are collected, and those with the best antitumor activity are grown in the laboratory to produce large populations that are infused into the patient. Prior to this work, it had not been clear if the human immune system could mount an effective response against mutant proteins produced by epithelial cell cancers and whether such a response could be used to develop personalized immunotherapies. Study results indicate that a T-cell response against a mutant protein can be harnessed to mediate regression of a metastatic epithelial cell cancer.