News
The founder of Theranos tries to change the subject
Late Monday afternoon, a few thousand clinical chemists packed into a cavernous convention hall in Philadelphia to hear a presentation by Elizabeth Holmes, the embattled CEO and founder of blood testing company Theranos. Her presentation, given in a controversial session of the American Association for Clinical Chemistry’s annual conference, was expected by many to be an opportunity for Holmes to finally reveal data that could back up the company’s lofty claims about its blood testing technology—technology now mired in scandal.
She didn’t provide data on Theranos’ existing finger-stick technology, which had been the subject of so much media attention in the past, or information about the accuracy of Theranos’ tests. She did not address the critical question of how she would continue to run the company if she is barred from operating a lab. Instead, Holmes spent most of her time introducing a new, and unrelated, Theranos device, which she described as "the result of hundreds of scientists’ work over many years." It’s called the "miniLab": a proprietary machine, about the size of a small printer, designed to run tests on small samples of blood, which seems, at first look, to offer the potential to conduct tests remotely. Holmes explained that the device has not been approved by the Food and Drug Administration but that the company is pursuing regulatory approval.
The Latest Research on Cannabis Use and Testing, Premature Death, and Labs-on-a-Chip to Be Featured at the 68th AACC Annual Scientific Meeting
At the 68th AACC Annual Scientific Meeting & Clinical Lab Expo visionaries in the field will illuminate the pioneering research and technology paving the way for better clinical testing and patient care. Explore the latest research on:
Cannabis: Recent research has revealed that determining whether a driver is impaired by marijuana is much more complicated than testing for blood alcohol content. The latest findings on the impact of marijuana on driving and overall health, as well as the newest developments in testing for cannabinoids in blood and saliva will be presented. Researchers from Calgary Laboratory Services will also present a study on a new urine test to detect cannabis and its metabolites that is accurate and cost-effective.
Halving premature death: An overview of the major causes of death in different parts of the world, with a focus on preventable causes of mortality such as tobacco, which still accounts for six million deaths worldwide each year. Researchers will also explain how global efforts to tackle these preventable causes could cut rates of premature death in half.
Innovative technology: Delve into the programmable bio-nano-chip, a mobile health testing platform that could make it possible to diagnose conditions such as cancer, cardiovascular disease, and infectious diseases with a device the size of a credit card chip. In a separate plenary, discussion on the "intelligent" surgical knife will occur, a novel device that couples electrosurgical tools to mass spectrometry.
Auckland lab tech caught accessing patient records 890 times can return to work
An Auckland District Health Board lab technician has been censured after inappropriately prying into medical records. Rosalinda Zabala inappropriately accessed the medical records of patients just short of 900 times in a three year period. Zabala was caught after she accessed the records of a one-year-old patient, who was a distant relative. She raised concerns about the child's liver function results to a nurse in front of the parents, who were not aware of the results. A manager conducted an audit of Zabala's database use and found she had repeatedly accessed the records of other patients, including family church members and her own record.
Zabala, a 15 year employee, admitted her wrongdoing when confronted by management and subsequently was fired in 2014. In a decision released in July, the Health Practitioners Disciplinary Tribunal said Zabala was penalized enough by losing her job. She was censured for the misconduct, charged $4000 in costs and would be required to take a course on ethics, privacy and confidentiality. The Tribunal did not think there was any ongoing issue of patient safety that required a suspension.
Leadership
Effective management to staff communication
Effectively communicating with your staff is a critical skill for laboratory managers. In particular, staff members have to feel that the manager is providing valid information, not withholding relevant information and is willing to listen. If the manager can accomplish this, there is no need for staff to seek information elsewhere. Timely communications can reduce rumors, improve productivity and improve morale.
So what can lab managers do to earn communication credibility? Read the full article to find out how to:
Articulate clear mission and vision statements for the laboratory
Speak honestly
Be precise, clear, and specific
Actively listen
Adopt a participatory management style: allow employees to have a sense of ownership
Practice "management by walking around" (MBWA)
Establishing effective bi-directional communication requires thought and constant effort. However, it’s well worth the effort.
Hematology
Hematology researchers develop new bio-engineered clotting factor to control bleeding
Every five minutes someone in the U.S. dies from a blood clot, through its role in strokes, heart attacks or other severe conditions. Doctors use anticoagulant drugs such as warfarin (Coumadin), Xarelto, Eliquis and Pradaxa to prevent clots. However, all anticoagulants increase the risk of bleeding.
Hematology researchers have developed a novel genetically engineered clotting factor that can control bleeding in animal models. If the factor proves effective in humans, it may provide a quick-acting countermeasure for surgery patients and others vulnerable to serious bleeding as a result of new blood-thinning drugs. Rodney Camire, PhD, a hematology researcher in the Raymond G. Perelman Center for Cellular and Molecular Therapeutics at The Children's Hospital of Philadelphia, and team developed the molecule by modifying coagulation FXa, a naturally occurring protein active in blood clotting.
Using bioengineering techniques, the researchers altered the shape of FXa into a novel variant that is more potent, longer-lasting and safer than wild-type (naturally occurring) FXa. Their novel variant is designated FXaI16L. In the current study, the variant safely restored blood-clotting ability in injured mice that had previously received FXa inhibitors.
Transfusion Medicine
Warm autoimmune hemolytic anemia and direct antiglobulin testing with a false-negative result in a 53-year-old man: The DAT will set you free
Warm autoimmune hemolytic anemia (WAIHA), the most common of the relatively uncommon autoimmune-mediated hemolytic anemias (AIHAs), is mediated by polyclonal immunoglobulin (Ig)G autoantibodies in most cases. This article presents a case of WAIHA involving a direct antiglobulin test (DAT) with an initially negative result. Using a modified DAT protocol, repeat testing of the same specimen material from a previously healthy 53-year-old man yielded positive results. This case demonstrates that investigation of an apparently negative DAT result plays a critical role in the differential diagnosis of patients with rapidly progressing hemolytic anemia and the reversal of that decline.
Read this interesting case study and review the lab testing completed that put together the final conclusion.
Microbiology
Mouse study offers hope for vaccine against chlamydia
A new Canadian study using mice suggests there is hope for a vaccine to protect against chlamydia, a common, sexually transmitted infection that can render young women infertile if left untreated. The vaccine works by interrupting the process by which chlamydia infects host cells, said senior researcher James Mahony, a professor of pathology and molecular medicine at McMaster University. In female lab mice, the vaccine essentially halted the spread of chlamydia and prevented sterility. "The vaccine reduced the amount of bacteria in the vagina by about 95%," Mahony said. "More importantly, it reduced the pathology [disease] in the fallopian tubes by about 85 percent, which is quite remarkable. That's probably enough to prevent infertility." To develop the vaccine, Mahony and his colleagues focused on the protein secretion system used by chlamydia to invade cells. Chlamydia can only grow inside cells, and so it must invade cells to spread, Mahony explained. When the bacteria comes into contact with a cell, it secretes proteins that penetrate the cell and facilitate the process of invasion. Out of 20 different proteins involved three were crucial to the process and thus, vaccines were created specifically for these.
Anatomic Pathology
World's oldest example of cancer found in 1.7 million-year-old fossil
The oldest known example of cancer has been detected in the fossil of an early human who walked the Earth approximately 1.7 million years ago. Up until now, the oldest known human fossil associated with evidence of cancer dated back to around 3,000 BC.
The discovery by British and South African scientists contradicts theories that cancer is a modern disease, predominantly caused by lifestyle factors. "…our studies show the origins of these diseases occurred in our ancient relatives millions of years before modern industrial societies existed," states Edward Odes from the University of the Witwatersrand.
The cancer has been identified as an osteosarcoma, an aggressive form of the disease which usually affects younger individuals in modern humans, and typically results in early death if left untreated. Archaeologists on a collaborating team also found a two million-year-old fossil of a benign cancer, which was discovered in the vertebrae of a child.
Want to see it? Watch this video
Molecular Biology
Spartan Bioscience Announces First Rapid APOE Genetic Test to Accelerate Clinical Drug Trials for Alzheimer’s Disease
By 2050, the number of people age 65 and older with Alzheimer's disease may nearly triple from 5.2 million to 13.8 million in the United States alone. Spartan Bioscience today announced the first rapid Apolipoprotein E (APOE) genetic test to identify mutations associated with increased risk of late-onset Alzheimer’s disease. The Spartan Cube test, the world’s smallest DNA-testing device, provides results in 30 minutes from a patient-friendly non-invasive cheek swab.
One-in-four people carry APOE genetic mutations that increase the risk of developing Alzheimer’s. These genetic carriers can be ideal clinical trial candidates, and the Cube can accelerate the identification and enrollment of these patients. For example, the Spartan Cube enables patient testing in doctors’ offices, walk-in clinics or even nursing homes. Paul Lem, M.D., founder and CEO of Spartan Bioscience, says Spartan wants to partner with doctors and researchers conducting clinical trials for Alzheimer’s disease.
Research
Zika now tied to miscarriage
Researchers are reporting a case of miscarriage tied to maternal infection with the mosquito-borne Zika virus. "Data linking Zika virus infection to fetal death have been reported in only a handful of cases," wrote a team led by Dr. Annemiek van der Eijk, of Erasmus Medical Center in Rotterdam.
The researchers said a 31-year-old Dutch woman lost her baby at 11 weeks' gestation, after contracting Zika on a trip to the South American country of Suriname. Suriname borders Brazil, which has been hit hard by thousands of cases of Zika-linked microcephaly. Published in the New England Journal of Medicine, researchers describe how the pregnant woman became ill with headache, joint pain and rash the day after she returned to the Netherlands after more than three weeks in Suriname. She recovered after six days but about two weeks after her symptoms first emerged, doctors found no fetal heartbeat at a routine ultrasound. Traces of Zika virus were found in amniotic fluid, placental tissue, and in the mother's urine and blood. The virus was also found in fetal stem cells, suggesting that Zika "replicates in [these cells] involved in early stage embryo development," the researchers explained. The Dutch team's findings suggest that the "window" for testing a pregnant woman for the virus may need to be expanded beyond the 14 day recommendation.
Related Article: Antibodies Identified That Thwart Zika Virus Infection
Related Article: CDC issues historic travel warning over Miami Zika outbreak
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