A Weekly Compilation of Clinical Laboratory and Related Information
from The Division Of Laboratory Programs, Standards And Services
February 12, 2015
- 58 Million Nonsmokers in US Are Still Exposed to Secondhand Smoke
- Lawmakers to Rethink Requiring Encryption in HIPAA
- ASCP Announces New Choosing Wisely® Recommendations
- What Does It Mean?
- German Drugmaker Stada to Launch Rapid Test for Ebola
- Study Shows Iron Supplementation after Blood Donation Shortens Hemoglobin Recovery Time
- Scientists Discover Organism That Hasn’t Evolved in More Than 2 Billion Years
- Mini Synthetic Organism Instead of Test Animals
- 2015 ACIP Adult Schedule Highlights Pneumococcal Vaccine
- HPV Vaccinations Don’t Lead to Riskier Sexual Behavior Among Girls, Study Suggests
- Chronic Fatigue Syndrome Gets a New Name
- GAO: CMS on Target with ICD-10 Readiness Efforts
- AMA Partners with Incubator to Build Better Health IT Systems
View Previous Issues - Healthcare News Archive
58 Million Nonsmokers in US Are Still Exposed to Secondhand Smoke
Although secondhand smoke (SHS) exposure in the United States dropped by half between 1999 to 2000 and 2011 to 2012, one in four nonsmokers – 58 million people – are still exposed to SHS, according to a new Vital Signs(http://www.cdc.gov/vitalsigns/tobacco/) report from the Centers for Disease Control and Prevention. Data from the National Health and Nutrition Examination Survey (NHANES) show that declines in exposure to SHS have been slower and exposure remains higher among children, blacks, those who live in poverty, and those who live in rental housing. The report finds two in every five children aged three to 11 years are still exposed to SHS. The study assessed exposure using cotinine, a marker of SHS found in the blood.
Lawmakers to Rethink Requiring Encryption in HIPAA
In light of the cyberattack against Anthem, federal officials plan to review whether HIPAA should require encryption, according to the Associated Press. The Senate Health, Education, Labor and Pensions committee said it will take up the matter as part of a bipartisan review of health information security. "We need a whole new look at HIPAA," David Kibbe, CEO of DirectTrust, a nonprofit working to create a national framework for secure electronic exchange of personal health information, told the AP. Information on up to 80 million consumers—including names, birth dates, addresses, email addresses, employment information and Social Security/member identification numbers—were compromised in the attack on Anthem. That information reportedly was not encrypted.
AAB and NILA Urge the FDA and CMS to Take a New Approach toward Overseeing LDTs
The American Association of Bioanalysts (AAB), an administrator of one of the nation’s full-service proficiency testing programs, and the National Independent Laboratory Association (NILA), representing community and regional clinical laboratories across the country, believe a process must be in place to ensure that laboratory developed tests (LDTs) are accurate, reliable and reproducible and that this can be achieved by modernizing the current CLIA program and ensuring the FDA has a guided role in the oversight of tests deemed to be high risk.
AAB’s and NILA’s position on the regulation of LDTs outlined in comments filed to the FDA and at the FDA Stakeholder Meeting held on January 8-9, 2015 focus on the following tenants:
- Any new regulation of LDTs must be done through notice and comment rulemaking.
- LDTs should not be regulated as medical devices and a separate regulatory pathway is required both within the FDA for a limited number of tests and through CLIA for all other tests.
- The oversight of LDTs should be through a risk-based approach that ensures the analytic and clinical validity of the tests
- CLIA should be modernized to support the oversight LDTs and a modified proficiency testing program should be developed to test the accuracy of laboratory developed tests.
Differentials in the Concentration of Health Expenditures across Population Subgroups in the U.S., 2012
Estimates of health care expenses for the U.S. civilian noninstitutionalized (community) population are critical to policymakers and others concerned with access to medical care and the cost and sources of payment for that care. In 2012, health care expenses among the U.S. community population totaled $1.35 trillion. Medical care expenses, however, are highly concentrated among a relatively small proportion of individuals in the community population. As previously reported in 1996, the top 1 percent of the U.S. population accounted for 28 percent of the total health care expenditures and the top 5 percent for more than half. More recent data have revealed that over time there has been some decrease in the extent of this concentration at the upper tail of the expenditure distribution.
- In 2012, the top 1 percent ranked by their health care expenses accounted for 22.7 percent of total health care expenditures with an annual mean expenditure of $97,956. Overall, the top 50 percent of the population ranked by their expenditures accounted for 97.3 percent of overall health care expenditures, while the lower 50 percent accounted for only 2.7 percent of the total.
- Individuals age 65 and older were characterized by substantially less concentrated levels of health care spending relative to their younger counterparts. Alternatively, the elderly had the highest mean levels of health care expenditures relative to younger population subgroups at the top quantiles of the expenditure distribution.
- The top 5 percent of the uninsured population under age 65 ranked by their health care expenses accounted for 58.9 percent of the health care expenditures incurred by this subpopulation with an annual mean of $14,565. Conditioned on insurance coverage status, the uninsured had the lowest annual mean expenses.
- The top 5 percent of individuals with four or more chronic conditions accounted for 29.7 percent of health care expenditures for this subpopulation with an annual mean of $78,198. Based on chronic condition status, persons with four or more chronic conditions had the lowest concentrated levels of health care expenditures and higher annual mean expenses at the top quantiles of the expenditure distribution.
ASCP Announces New Choosing Wisely® Recommendations
ASCP has released a new set of Choosing Wisely® recommendations targeting laboratory tests that are commonly ordered, but not always appropriate. ASCP has been a partner in the Choosing Wisely® campaign, an initiative of the American Board of Internal Medicine (ABIM) Foundation, since 2013 when the Society released its first set of Choosing Wisely® recommendations.
- Don’t order an erythrocyte sedimentation rate (ESR) to look for inflammation in patients with undiagnosed conditions. Order a C-reactive protein (CRP) to detect acute phase inflammation.
- Don’t test vitamin K levels unless the patient has an abnormal international normalized ratio (INR) and does not respond to vitamin K therapy.
- Don’t prescribe testosterone therapy unless there is laboratory evidence of testosterone deficiency.
- Don’t test for myoglobin or CK-MB in the diagnosis of acute myocardial infarction (AMI). Instead, use troponin I or T.
- Don’t order multiple tests in the initial evaluation of a patient with suspected non-neoplastic thyroid disease. Order thyroid-stimulating hormone (TSH) and, if abnormal, follow-up with additional evaluation or treatment depending on the findings.
What Does It Mean?
The enthusiasm surrounding personalized medicine is overshadowing a vital issue: many physicians aren't familiar with how to interpret and communicate genetic testing results, the New Yorker's Cynthia Graber writes. For example, she recounts a situation in which a little girl underwent genetic testing to try to determine the cause of her poor coordination and short stature. The test revealed that she had a deletion on chromosome 22 that was a marker for DiGeorge syndrome, a condition for which there is no cure. However, a second look at the results found that the girl was missing a different part of the region than the one linked to the syndrome. Graber says that such mistakes are common and could lead to unnecessary surgeries or influence maternity care.
German Drugmaker Stada to Launch Rapid Test for Ebola
German drugmaker Stada will launch a test next month that can diagnose Ebola virus infections within minutes, a move it hopes will help to slow the spread of the disease. The test, which is being marketed by Stada, was developed and produced by unlisted German diagnostics firm Senova. It yields results based on pre-treated patient blood samples within about 10 minutes. Stada said its main use would likely be to diagnose the deceased because their body fluids do not need to be pre-treated before testing. Contact by mourners with their dead relatives is a common way for the disease to be transmitted. "The viral load in people who have died of Ebola is so high that a mere throat swab suffices to perform the rapid test," Senova owner Hans Hermann Soeffing said.
Blood Test Aims to Detect Parkinson's in Early Stages
Researchers have developed a blood test that they say could help neurologists detect Parkinson's disease and track the illness as it progresses. "If successful, we expect our findings will translate into a valuable diagnostic tool for Parkinson's disease," said study co-author Judith Potashkin, professor of cellular and molecular pharmacology at Chicago Medical School, Rosalind Franklin University of Medicine and Science. Researchers have developed a blood test that they say could help neurologists detect Parkinson's disease and track the illness as it progresses. "If successful, we expect our findings will translate into a valuable diagnostic tool for Parkinson's disease," said study co-author Judith Potashkin, professor of cellular and molecular pharmacology at Chicago Medical School, Rosalind Franklin University of Medicine and Science.
Study Identifies Metastasis-specific MicroRNA Signature in Colorectal Cancer
Researchers from Baylor University and the National Cancer Institute have published new data suggesting that a signature of four microRNAs can be used to predict colorectal cancer (CRC) patients who will go on to develop metastatic disease. The findings, which are currently being validated in samples from additional patients, may lead to the development of a test that oncologists can use to inform their decisions on which patients require aggressive chemotherapy after tumor removal and which do not. When dealing with CRC patients with Stage I, II, or III disease — wherein a tumor is large but has not spread beyond nearby lymph nodes to distal tissues or organs — oncologists have no way to know which should receive aggressive treatment and which should not, a key consideration given the side effects and high costs of such therapies, Baylor researcher Ajay Goel, who led the newly published research, told GenomeWeb.
Indi Publishes Second Clinical Validation of Xpresys Lung, Turns Focus to Proving Clinical Utility
Integrated Diagnostics presented results from a second clinical validation study of its Xpresys Lung cancer test. Published this month in the Journal of Thoracic Oncology, the study, which looked at 141 blood samples from patients 40 years or older with lung nodules ranging between eight and 30 mm in diameter, found that the test could identify benign lesions in lung cancer patients with a negative predictive value of between 84 percent and 98 percent. The study follows an initial validation study the company published in Science Translational Medicine in 2013, weeks before commercial launch of the test. That study looked at 104 samples from four sites, finding that the test could identify benign lesions with NPV of 90 percent. Xpresys is intended to aid doctors in identifying lung nodules detected via CT scans as likely benign. The test uses multiple-reaction monitoring mass spec to quantify the levels of 11 proteins in patient blood samples.
ELISA Immunoassay Disease Testing on Your Smartphone
Though ELISA tests (enzyme-linked immunosorbent assays) are the gold standard for diagnosing a whole slew of infectious diseases, the technology has remained stuck within hospital labs. What if you could carry an ELISA machine with you in your pocket? Imagine field testing for diseases, halting their spread and initiating therapy at an early stage for those infected. Researchers at Columbia University have actually developed such a device that works in conjunction with a smartphone to provide results within minutes. The device uses the smartphone as the power source and performs a triplexed immunoassay for HIV antibody, treponemal-specific antibody for syphilis, and non-treponemal antibody for active syphilis infection. Such a combination immunoassay has not been previously available in a unified test.
Smartphone Accessory Diagnoses HIV and Syphilis in 15 Minutes
A new smartphone accessory capable of diagnosing HIV and syphilis has been developed and successfully field-tested in Rwanda. Powered by the energy from a smartphone, the device can simultaneously detect three infectious disease markers from only a finger prick of blood. The test takes 15 minutes and is the first instance of a device being created capable of replicating all the electronic, mechanical and optical functions of a lab-based blood test.
Study Shows Iron Supplementation after Blood Donation Shortens Hemoglobin Recovery Time
A National Institutes of Health-funded study comparing low dose iron supplementation to no supplementation in blood donors found that supplementation significantly reduced the time to recovery of post-donation lost iron and hemoglobin — an iron-rich protein that carries oxygen in red blood cells throughout the body. The results of the Hemoglobin and Iron Recovery Study (HEIRS), supported by NIH’s National Heart, Lung, and Blood Institute (NHLBI), appears Feb. 10 in the Journal of the American Medical Association. Blood donors are allowed to give one pint of blood every eight weeks. A major concern is that about 25-35 percent of regular donors develop iron deficiency. Since iron is needed for red blood cell production, low iron can cause fatigue and anemia — a condition in which the blood has a lower than normal number of red blood cells — and can lead to temporary ineligibility for future donations. It can take months to recover the lost iron. New research indicates a possible solution.
Scientists Discover Organism That Hasn’t Evolved in More Than 2 Billion Years
An international team of scientists has discovered the greatest absence of evolution ever reported — a type of deep-sea microorganism that appears not to have evolved over more than 2 billion years. But the researchers say that the organisms’ lack of evolution actually supports Charles Darwin’s theory of evolution. The findings are published online by the Proceedings of the National Academy of Sciences. The scientists examined sulfur bacteria, microorganisms that are too small to see with the unaided eye, that are 1.8 billion years old and were preserved in rocks from Western Australia’s coastal waters. Using cutting-edge technology, they found that the bacteria look the same as bacteria of the same region from 2.3 billion years ago — and that both sets of ancient bacteria are indistinguishable from modern sulfur bacteria found in mud off of the coast of Chile. “It seems astounding that life has not evolved for more than 2 billion years — nearly half the history of the Earth,” said J. William Schopf, a UCLA professor of earth, planetary and space sciences in the UCLA College who was the study’s lead author. “Given that evolution is a fact, this lack of evolution needs to be explained.”
Mini Synthetic Organism Instead of Test Animals
In medical research, animal-based experiments have thus far been a necessary evil. Fraunhofer researchers have developed a highly promising alternative, however: They are developing a mini-organism inside a chip. This way, complex metabolic processes within the human body can be analyzed realistically. “Most medications work systemically - that is to say, on the organism as a whole. In doing so, toxic substances frequently emerge through metabolic processes, which in turn damage only certain organs,” explains Dr. Frank Sonntag of the Fraunhofer Institute for Material and Beam Technology IWS. Researchers at the Dresden-based institute, working jointly with the Institute for Biotechnology at the Technical University (TU) of Berlin, engineered a new kind of solution that could render the use of animal-based experiments superfluous in medical research: a multi-organ chip that faithfully replicates complex metabolic processes in the human body with startling accuracy. The results are ultimately even more predictive than those of animal-based experiments.
Gut Bacteria Byproduct Linked to Chronic Kidney Disease for the First Time
Cleveland Clinic researchers have, for the first time, linked trimethylamine N-oxide (TMAO) - a gut metabolite formed during the digestion of egg-, red meat- or dairy-derived nutrients choline and carnitine - to chronic kidney disease. TMAO has been linked to heart disease already, with blood levels shown to be a powerful tool for predicting future heart attacks, stroke and death. TMAO forms in the gut during digestion of choline and carnitine, nutrients that are abundant in animal products such as red meat and liver. Choline is also abundant in egg yolk and high-fat dairy products. The research team was led by Stanley Hazen, M.D., Ph.D., Chair of the Department of Cellular & Molecular Medicine for the Lerner Research Institute and section head of Preventive Cardiology & Rehabilitation in the Miller Family Heart and Vascular Institute at Cleveland Clinic, and W.H. Wilson Tang, M.D., Department of Cardiovascular Medicine in the Miller Family Heart and Vascular Institute and Lerner Research Institute. The research was published online and in the print edition of Circulation Research.
Compound Found in Grapes, Red Wine May Help Prevent Memory Loss
A compound found in common foods such as red grapes and peanuts may help prevent age-related decline in memory, according to new research published by a faculty member in the Texas A&M Health Science Center College of Medicine. Ashok K. Shetty, Ph.D., a professor in the Department of Molecular and Cellular Medicine and Director of Neurosciences at the Institute for Regenerative Medicine, has been studying the potential benefit of resveratrol, an antioxidant that is found in the skin of red grapes, as well as in red wine, peanuts and some berries. In a study published online Jan. 28 inScientific Reports, Shetty and his research team members reported that treatment with resveratrol had apparent benefits in terms of learning, memory and mood function in aged rats.
Long-Lived Immunotherapy Stem Cells
Researchers have tracked a type of immune cell called T memory stem cells in patients who received infusions of genetically modified lymphocytes more than a decade ago. According to a paper published on February 4 in Science Translational Medicine, the team found not only that a population of the stem cells are still present, but also that they give rise to other types of T lymphocyte.
'Smart' Insulin Hope for Diabetes
Scientists are hopeful that "smart" insulins which are undergoing trials could revolutionise the way diabetes is managed. Instead of repeated blood tests and injections throughout the day to keep blood sugar in check, a single dose of smart insulin would keep circulating in the body and turn on when needed. Animal studies show the technology appears to work - at least in mice. Scientists plan to move to human trials soon, PNAS journal reports. Experts caution that it will take years of testing before treatments could become a reality for patients.
2015 ACIP Adult Schedule Highlights Pneumococcal Vaccine
All adults aged 65 years and older should now receive the 13-valent pneumococcal conjugate vaccine (PCV13/Prevnar 13, Wyeth), in addition to the 23-valent pneumococcal polysaccharide vaccine (PPSV23/Pneumovax, Merck), according to the 2015 adult immunization recommendations from the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC). The new clinical guideline, "Advisory Committee on Immunization Practices Recommended Immunization Schedule for Adults Aged 19 Years or Older: United States, 2015," was published online February 2 in the Annals of Internal Medicine by David K. Kim, MD, from the CDC's Immunization Services Division, National Center for Immunization and Respiratory Diseases, Atlanta, Georgia, and colleagues, on behalf of the ACIP. The recommendations are also published on the CDC's website (http://www.cdc.gov/Features/Pneumonia/).
HPV Vaccinations Don’t Lead to Riskier Sexual Behavior Among Girls, Study Suggests
Controversy has swirled around the human papillomavirus vaccine for years, with some parents, pediatricians and politicians worried that requiring the inoculation would encourage teenagers to have sex. But a new study from Harvard University and University of Southern California researchers found that girls who received the vaccine didn't have higher rates of sexually transmitted diseases when compared with non-vaccinated girls. The findings, published in the Journal of the American Medical Association, suggest that the HPV vaccine doesn't result in riskier sexual behavior.
Chronic Fatigue Syndrome Gets a New Name
The Institute of Medicine proposed a new name and new diagnostic criteria for the condition that many still call chronic fatigue syndrome. An institute panel recommended that the illness be renamed “systemic exertion intolerance disease.” The term reflects what patients, clinicians and researchers all agree is a core symptom: a sustained depletion of energy following minimal activity, called post-exertional malaise. The new name “really describes much more directly the key feature of the illness, which is the inability to tolerate both physical and cognitive exertion,” said Dr. Peter Rowe, a member of the panel and a pediatrician at Johns Hopkins who treats children with the condition. The Institute of Medicine panel was convened at the request of the Department of Health and Human Services, the Centers for Disease Control and Prevention, the Food and Drug Administration and other federal agencies.
Blacks Account for More Than Half of New HIV Diagnoses: CDC
Blacks are diagnosed with HIV more often than any other group of Americans, and while their death rate from the disease is declining, it is still higher than in other racial/ethnic groups. Those are the findings of two new U.S. government studies reported. The findings show the need to redouble efforts to provide black Americans with better HIV prevention, diagnosis and care, the researchers, from the Centers for Disease Control and Prevention (CDC), said. The first study involved an analysis of data from CDC-funded HIV testing in 61 regions across the country in 2013. Blacks accounted for 45 percent of people tested for HIV, the largest proportion of any racial/ethnic group. Blacks also accounted for nearly 55 percent of all new HIV diagnoses. Among blacks diagnosed with HIV, gay men accounted for about 37 percent of the new diagnoses, according to the study.
GAO: CMS on Target with ICD-10 Readiness Efforts
The Centers for Medicaid & Medicare Services has taken positive steps to help prepare the healthcare industry for ICD-10, but every organization must prepare in advance if the transition is to be successful, according to a report published by the Government Accountability Office. In its review, GAO looked at the agency's activities to support the transition, as well as stakeholders' biggest concerns about preparation for the system and how those concerns were addressed. Additionally, GAO gave a draft of the report to the U.S. Department of Health and Human Services--which agreed with the findings.
Those findings, for which GAO spoke with 28 stakeholders, include:
- Educational material CMS has for covered entities on its website were found helpful by all 28 stakeholders
- CMS' ICD-10 website to aid small practices, Road to 10, was found helpful by 17 of the 28 stakeholders
- Tools to help providers know which codes to use in the new system were only found helpful by six of the stakeholders
AMA Partners with Incubator to Build Better Health IT Systems
The American Medical Association, a sharp critic of federal efforts to promote electronic health records, is taking its own path to stimulate health IT improvements and partnering with an incubator “to drive innovation,” according to an AMA statement. The AMA will operate what it describes as an “interaction studio” with Matter, a Chicago-based incubator that a year ago announced plans to lease 24,000 square feet in Chicago's massive Merchandise Mart. Matter's founders have been signing up entrepreneurs and plan to open early this year. Sixty-five companies are enrolled thus far. The AMA partnership will “create a flexible facility that will allow physicians, entrepreneurs, healthcare professionals and industry experts to test new models for healthcare delivery,” an AMA statement said.
Clinician Leadership, Governance Keys to Successful Health IT Implementation
SwedishAmerican Health System (SAHS) has recognized the importance of clinician leadership and governance in the successful rollout of IT projects, according to an article at Health Data Management. The Rockford, Illnois-based organization has created its governance framework around two bedrock principles, writes Chief Medical Information Officer Michael Polizzotto. Those principles are: 1.) The needs and opinions of clinical users should inform decisions about clinical IT; 2.) The IT decision processes will be standardized, transparent and responsive. SAHS has two advisory panels where clinical needs for IT are prioritized--the Physician Advisory Council and the Interdisciplinary Advisory Council. Those councils report to the eHealth Oversight Council, which is co-chaired by the chief medical officer and chief nursing officer.
A Phone So Smart, it Sniffs Out Disease
A research consortium headed by Professor Hossam Haick of the Technion-Israel Institute of Technology is developing a product that, when coupled with a smartphone, will be able to screen the user’s breath for early detection of life-threatening diseases. Funded by a grant from the European Commission, the SNIFFPHONE project will link Prof. Haick’s acclaimed breathalyzer screening technology to the smartphone to provide non-invasive, fast and cheap disease detection. It will work by using micro- and nano-sensors that read exhaled breath and then transfer the information through the attached mobile phone to an information-processing system for interpretation. The data is then assessed and disease diagnosis and other details are ascertained.
OPM Monitoring Recent Anthem Database Breach Containing 80M Records
The Office of Personnel Management is monitoring whether the recently reported hacked database at Anthem Inc. has affected any of the 1.3 million federal employees that the health insurer covers. Nextgov last week reported that Anthem informed the federal agency that it shut down the affected network following the breach of the database that stored about 80 million records of customers and employees. Anthem which is the nation's No. 2 health insurance company, runs the Blue Cross and Blue Shield Service Benefit Plan – also known as the Federal Employee Program – in several states, including California, New York and Virginia, according to Nextgov.
Beyond the EHR: Where Hospitals Are Aiming Next
Are hospitals and the IT shops supporting them, moving into a post-EHR era? The phrase has been slowly picking up momentum during the last several months and, now, a new study finds that IT shops are girding to focus more on non-clinical systems through 2020. "I believe we are in a post-EHR world right now," Glenn Tobin of the Advisory Board Company told Healthcare IT News Editor-at-Large Bernie Monegain. Market research firm Frost & Sullivan, meanwhile, found in the study it published this week that as hospitals look beyond EHRs, the coming challenges driven by the Affordable Care Act include “changing reimbursement models, competitive threats from non-traditional providers, and the rise of health insurance marketplaces,”.
FDA Commissioner Margaret A. Hamburg Stepping Down
Dear FDA Colleagues: It has been a privilege to serve as your FDA Commissioner for almost six years. So it is with very mixed emotions that I write to inform you that I plan to step down as FDA Commissioner at the end of March 2015. From creating a modernized food safety system that will reduce foodborne illness; advancing biomedical innovation by approving novel medical products in cutting-edge areas; and responding aggressively to the need to secure the safety of a globalized food and medical product supply chain, to taking critical steps to reduce the death and disease caused by tobacco, we have accomplished a tremendous amount in the last six years. We can honestly say that our collective efforts have improved the health, safety and quality of life of the American people.
Woman 'Cured by Lucky DNA Mutation'
A woman with a rare disease has been spontaneously cured in an event so improbable doctors say it is the medical equivalent of a lottery win. The woman in her 50s, who is not being named, was plagued by warts and infections as part of "WHIM syndrome" – caused by a defective immune system. But U.S. doctors say a fluke DNA mutation, reported in the journal Cell, effectively cured her in her 30s. One doctor said the odds of it happening were "astronomically low".
Germany Is Battling a Measles Outbreak That Is 10 Times Worse Than the One in the U.S.
The United States has been shocked by a surge in measles cases with more than 100 incidents in January alone. This, however, is much less worrisome than a current outbreak in Germany. While authorities there had hoped to completely eliminate the disease this year, 254 new cases emerged in January, primarily in Berlin. If we consider that the German population is only one fourth of the United States', the German measles surge was about 10 times worse than the one in the United States in January, relative to the total population.
Myriad Settles BRCA Patent Case with Quest; Only GeneDx Lawsuit Remains
Quest Diagnostics and Myriad Genetics have settled their patent dispute related to BRCA testing. Myriad along with its co-patent holders and Quest have agreed to "dismiss their lawsuits, claims, counterclaims, and disputes related to Myriad's patent claims on BRCA1 and BRCA2 in the litigation," Quest said in a statement. On October 2013, Quest filed a lawsuit against Myriad in the Central District of California asking for declaratory judgment that it wasn't infringing 14 patents owned or exclusively licensed to Myriad. A few weeks later, Myriad countersued Quest alleging patent infringement in the U.S. District court for the District of Utah. Around this time, Quest had launched a next-generation sequencing testing service, called BRCAvantage, which aimed to help doctors assess their patients' risk of breast and ovarian cancer based on whether they carried mutations in BRCA1/2 genes. Under the terms of the settlement with Myriad, Quest is free to sell its BRCAvantage and other BRCA-related testing services, and develop additional testing products based on the patents asserted by Myriad in the lawsuit.
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