First human embryos edited in U.S.
The first known attempt at creating genetically modified human embryos in the United States has been carried out by a team of researchers in Portland, Oregon, MIT Technology Review has learned.
To date, three previous reports of editing human embryos were all published by scientists in China. The effort, led by Shoukhrat Mitalipov of Oregon Health and Science University, is believed to have broken new ground both in the number of embryos experimented upon and by demonstrating that it is possible to safely and efficiently correct defective genes that cause inherited diseases. In altering the DNA code of human embryos, the objective is to show that they can eradicate or correct genes that cause inherited disease, like the blood condition beta-thalassemia.
The process is termed "germline engineering" and some critics say such experiments could open the floodgates to a brave new world of "designer babies" engineered with genetic enhancements. The U.S. intelligence community last year called CRISPR a potential "weapon of mass destruction." Mitalipov’s team moved into embryo editing coinciding with a report by the U.S. National Academy of Sciences that was widely seen as providing a green light for lab research on germline modification.
Related Article: Researchers Discover How CRISPR Proteins Find Their Target
Is laboratory medicine ready for artificial intelligence?
Scientists are harnessing the speed of modern computers and programming them with cognitive algorithms and sophisticated decision trees to help solve complex medical problems. This rapidly advancing science was the focus of the 2017 AACC Expo for the Chair’s Invited Session, "Is Artificial Intelligence in Genomics Ready for Prime Time?"
"AI can be considered disruptive technology that significantly changes how we perform laboratory medicine." Stanley Lo, PhD, chair of the 2017 AACC Annual Meeting Organizing Committee. A complimentary group of speakers discussed the topic - click on the article title to read full details.
Michael Berger, PhD, examined the use of the MSK-IMPACT assay to look for mutations in some 468 cancer genes. This targeted gene therapy can potentially cure the cancer and opens up exciting possibilities.
Patrick McNeillie, MD, clinical lead and senior architect of IBM’s Watson Health project, discussed how advanced clinical diagnostics algorithms can allow computers to relate diverse clinical literature with patient data to generate an "outcome report." This contextual information-based approach helps the system be intelligent.
Nirali Patel, MD, explained how IBM Watson is helping her institution to help fulfill the promise that "healthcare should be tailored to meet the needs of the individual."
Seventh Sense promises a painless way to draw blood — we tried it, and barely felt a thing
Finding less painful and more efficient ways to draw blood is a holy grail for medical entrepreneurs. Seventh Sense Biosystems, a start-up based in Massachusetts, is among the furthest along in this quest. The market for direct-to-consumer lab testing is on the rise and expected to surpass $350 million by 2020, according to a 2016 report. Seventh Sense has raised $33 million in financing to date.
This year, the U.S. Food and Drug Administration approved its 'TAP device' for use in hemoglobin A1C testing. The company claims that its device is virtually painless, so Christina Farr opted to give it a try at the CNBC offices. "The company's chief business officer Stuart Blitz placed the device on my upper arm. After he hit a green button, 30 microneedles pierced the outer layers of my skin and quickly retracted. I didn't feel a thing until the device starting sucking up about 100 microliters of my blood, and even then I barely noticed it." said Farr in her article. The company is hoping that it can get approval in the coming months for anyone to take their own blood at home. In Arizona, consumers can order their own tests without a doctor's note.
Young laboratorians discover path to leadership
While leadership may not initially seem critical early in your career, seizing opportunities for growth and influence early on can help us be recognized as leaders long before an official title confers it. At a Society for Young Clinical Laboratorians workshop, attendees discovered fresh strategies to understanding and achieve this transition.
Susan Evans, PhD spoke to the benefits of creating impactful relationships between medical centers and vendors. "Partnerships can start small, but keep an eye toward renewal," Evans said.
Michael Astion, MD, PhD provided the audience with a "conflict management toolbox," a list of tips for mitigating workplace disagreements in effective ways before they become inflated.
Juan David Garcia, MBA, BS(MT) gave an excellent overview of how to effectively negotiate contracts for the clinical lab. He reminded the audience that negotiation does not have to stop at capital costs and can include such items as service agreements, LIS interface costs, and employee training.
Josie Foranoce, MT(ASCP), shared practical information on how a lab leader can drive a collaborative and productive team. Foranoce stressed the importance of lab leaders remaining engaged, happy, and enthusiastic at work—even though these qualities may not be in our job descriptions. She encouraged audience members to try regular "employee rounding" to stay informed about possible barriers.
Jaffe vs. Enzymatic Method for Serum Creatinine Measurement – Lablogatory
This article explores considerations for deciding between the Jaffe and enzymatic methods for measuring serum creatinine. The Jaffe method is prone to the risk of interference and some experts recommend against using it. The Jaffe method is less expensive than the enzymatic assay ($0.30 vs $2.00 per test based on 2014 list prices) and a hospital in Utah decided to determine the risk of switching to the cheaper assay.
They compared the eGFRs provided by the enzymatic and Jaffe methods to estimate how often patients might be misclassified. Focusing on the 60 ml/min decision limit, they found that 17 of 500 (3.4%) of measurements were discordant. Some of these discordant results would be due to imprecision. Discordance due to imprecision would have small differences and are unavoidable – they would occur using any method. Discordance due to interference would be expected to have larger differences and could be avoided by using the enzymatic method. They used statistical techniques to estimate the proportion of discordances that were due to interference vs imprecision and found that about 60% of the discordance at the 60 ml/min limit was due to interference. In summary, their risk analysis showed that using the Jaffe method would pose about a 2% rate of avoidable misclassification which presented some potential risk to patients. The nephrologists felt the risk was low but, in theory, disease could unnecessarily progress in a patient with a false negative diagnosis.
Ultimately, the risk assessment led them to get the best of both worlds by using BOTH methods. They defined a zone of risk surrounding the 60 ml/min eGFR decision limit. Results in this zone would have some risk of misclassification whereas results outside of the zone would be unlikely to be misclassified using the Jaffe method. All creatinine measurements are initially performed using the Jaffe method. If the result is outside the risk zone, the result is reported. If results fell within the risk zone, they were repeated with the enzymatic method and the results of the enzymatic method are reported. This reflex procedure saves money while avoiding risk. The reflex rate is approximately 15%.
Read the entire article by clicking on the title for a complete explanation and figures.
FDA clears test to help diagnose, identify blood cancer type
The US Food and Drug Administration (FDA) has approved the marketing of a new lab test used with flow cytometry to aid in the detection of several hematologic malignancies—including acute and chronic leukemias, myelodysplastic syndromes, myeloproliferative neoplasms, multiple myeloma, and non-Hodgkin lymphoma.
The new test, ClearLLab Reagents (T1, T2, B1, B2, M), can detect cancerous cells in the blood, bone marrow, and lymph nodes—and uses fluorescent dyes to mark cell-surface proteins for further analysis with flow cytometry—providing laboratories information about what type of blood cancer is present. The approval of the test was based on a study that compared the test’s results to current methods of cancer detection. The study was conducted on 279 samples at four, independent sites and showed that the results of the test aligned with each study site’s final diagnosis 93.4% of the time and detected the presence of cancer 84.2% of the time. The FDA notes that a trained professional must review the results of the test. Along with this authorization, the FDA will establish special controls to clarify the FDA’s expectations in assuring that the test is reliable, accurate, and clinically relevant.
Reduced blood transfusions and costs in the treatment of patients with blood diseases
This is the world's first study to look at the impact of a Patient Blood Management (PBM) Program on transfusion use and outcomes in patients with hematological malignancies (disorders of the blood and blood forming tissues, such as leukemia). The study, published in Transfusion1537-2995), looked at the impact of the Western Australia PBM Program on transfusion utilization, outcomes and costs in patients treated for hematological disease. It included 695 admissions over 3.5 years to two major hospitals. The results showed the program was associated with a 39% reduction in red blood cell transfusion and a 35% reduction in platelet transfusions. This translated to an estimated blood product related cost saving of up to US$2 million. Shannon Farmer, Adjunct Research Fellow at the University of Western Australia Medical School and Scientific Associate of IFPBM said, "This study suggests that patients undergoing chemotherapy with hematological disease may tolerate much lower levels of hemoglobin than previously thought. The transfusion threshold, the hemoglobin value at which a transfusion is given, dropped significantly from 8.0 g/dL at the beginning of the study to 6.8 g/dL at the end. This was associated with significant reductions in transfusion and substantial costs savings without evidence of harm to the patients. In fact, it was associated with a trend toward improved survival."
Expert advice on picking the correct genetic test
Each patient’s particular clinical situation is really the most important driver when deciding which type of genetic testing to order. Linnea Baudhuin, PhD, and Carol Saunders, PhD, led an AACC Expo interactive session that sought to take some of the guesswork out of ordering complex genetic tests by outlining the pros and cons of ordering gene panels, whole-exome, and whole-genome testing.
There are many differences between the two types of tests that people are unaware of. In reality, whole-exome and whole-genome testing really are more like screening tests, due to limits of sensitivity. However, in cases where a patient has a very non-specific phenotype, this type of testing makes more sense, she explained. Another common misconception about this type of analysis is that it tests for "everything." The truth is current technologies miss a lot in the genome. "Hopefully most people realize by now that there are poorly covered or under-represented regions," Saunders said. "As with any test, it’s important to realize the limitations."
Educating clinicians is a key element in effectively utilizing genetic testing. Both speakers also emphasized the importance of genetic counselors in this process. These key players serve as the face of the laboratory, gather additional clinical information about patients, and guide ordering of correct tests or offer alternatives when appropriate.
Collaboration between pathologists, medical laboratories, and hospital staff substantially reduced hospital-acquired infections
It’s now been almost nine years since the Medicare Program stopped paying hospitals and other providers for certain hospital-acquired conditions (HACs), including hospital-acquired infections (HAIs). The goal is to substantially reduce the number of HACs and HAIs, thus improving patient outcomes, while substantially reducing the healthcare costs associated with these conditions.
A recent report by the Agency for Healthcare Research and Quality (AHRQ) indicates that there has been progress. The AHRQ report noted a 21% decline in HACs between 2010 and 2015, a reduction of more than 3.1 million HACs and nearly 125,000 patient deaths due to HACs. In 2015 alone, nearly one million fewer HAC incidents occurred. The reduction saved "approximately $28 billion in healthcare costs," an outcome which, the AHRQ report notes, is the result of increased attention to safety protocols in hospitals. The fight to reduce HAIs and HACs is showing significant progress, and clinical laboratories, working in tandem with clinicians and prevention programs, are a fundamental part of the success. Clinical pathologists and laboratories often are the front line in prevention and management of HAIs, and the work they do in identifying infections is essential in the assessment and control of those infections.
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