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  • sam patrick posted an article
    Improvements may one day improve the effectiveness and safety of chemotherapy see more

    For patients with cancer, the tumor-killing power of chemotherapeutic drugs is a double-edged sword. While many cancer drugs kill tumor cells, they can also harm healthy cells as they travel throughout the bloodstream.

    “A major limitation of chemotherapy agents is that only a tiny fraction goes to their targeted tumor,” said Dieter Haemmerich, Ph.D., D.Sc., professor at the Darby Children’s Research Institute within the Department of Pediatrics at the Medical University of South Carolina (MUSC). “As a result, there are side effects that include damage to the heart.”

    But what if you could “cleanse” the blood of chemotherapeutic drugs to reduce their harmful side effects? 

    In an article published in March 2022 in the journal Cancers, an MUSC research team led by Haemmerich reported that it had developed a device to remove excess chemotherapeutic drugs from circulation after cancer treatment. Using this device, the team removed 30% of the administered drug by one hour after treatment. Seed funding to develop the device was provided by a High Innovation - High Reward grant from the South Carolina Clinical & Translational Research Institute’s pilot project program.

    Haemmerich and his colleagues, including Katherine Twombley, M.D., a professor in the MUSC Department of Pediatrics, Division of Pediatric Nephrology, focused on doxorubicin (DOX), which is one of the most widely used chemotherapy drugs in adults and children. 

    DOX is also known to be toxic to the heart. This toxicity is particularly detrimental in pediatric patients, since any resulting heart failure will have negative health effects for the rest of the child’s life. In a 2006 clinical trial, DOX reduced cardiac function in children with leukemia, and steroid therapy was required to reduce its damaging effects.

    Despite its toxicity to the heart, DOX is a popular chemotherapy drug because it is highly effective at stopping cancer cells from dividing.

    “Doxorubicin works by basically damaging DNA,” said Yuri Peterson, Ph.D., an associate professor in the Department of Drug Discovery and Biomedical Sciences in the MUSC College of Pharmacy and an author of the article. “That is useful for treating cancer, but it can also cause off-target side effects like hair and bone marrow loss.” 

    Recent efforts to target DOX more precisely to the tumor site have included encapsulating it inside temperature-sensitive nanoparticles. These tiny particles are intact at normal body temperature and carry the drug through the bloodstream to the tumor. There, they can be heated with a probe to around 105 degrees Fahrenheit to release their DOX cargo.

    However, the technique has its own limitations. Only a fraction of the administered nanoparticles release their cargo when the heat is applied at the tumor site. Once the nanoparticles break down in the body, which can take as little as an hour, the remaining drug enters the bloodstream and can then cause side effects. 

    The MUSC research team wanted to improve outcomes with this technique by developing a device that would remove the leftover DOX after treatment.

    Using a rodent model of cancer, the researchers injected the heat-sensitive DOX nanoparticles and applied heat at the tumor site to release DOX. After treatment, they cleansed the blood of leftover DOX by first passing it through a heating element to get the nanoparticles to release the drug and then through an activated carbon filter to remove the drug from the blood before it was returned to the rodents’ circulation.

    Krishna Ramajayam, Ph.D., a postdoctoral fellow in Haemmerich’s laboratory in the Division of Pediatric Cardiology at MUSC, designed the heating element in the filtration device and supported the imaging studies for monitoring drug release and filtration.

    “Since the device is computer controlled, you can have very precise heating to ensure that the drug is released,” said Ramajayam. “The most exciting part for me is addressing both delivery and removal of the drug, which will improve patients’ quality of life immensely.”

    Importantly, the team also developed a method for detecting drug levels in the blood in real time to ensure that the drug is effectively removed.

    “By imaging the blood before and after filtration, we can actually predict how much drug is being removed in real time in the clinic,” said Anjan Motamarry, Ph.D., who completed work on the study while a doctoral student in Haemmerich’s lab before transitioning to a job in industry. “This would be very useful information for a clinician who needed to make a decision about when to stop filtration.

    ”Reducing the exposure of patients to leftover chemotherapy drugs could allow them to recover faster, with fewer side effects. It could also enable them to receive more chemotherapy cycles in the future in case additional treatment is necessary to kill the cancer cells.

    “Every drug has a maximum tolerated dose that you cannot go beyond,” said Motamarry. “Since we are removing the leftover drug after treatment, you can actually give an additional dose if the first cycle is not sufficient, which would not be possible if the drug was not removed.”

    Filtering the blood through the device also led to nearly three times less DOX in the heart, as measured using mass spectrometry at the MUSC Drug Discovery Core. Peterson and Thomas Benton, Ph.D., who was a doctoral student at MUSC at the time of the study, performed the measurements.

    These promising results suggest that the new device could reduce side effects in the heart that can be caused by chemotherapy, but more studies will be needed to confirm that promise.

    “If you deliver less drug to the heart, you will probably have fewer side effects,” said Haemmerich. “Our next step is to test the function of the heart directly after using this method in long-term animal tumor studies.”

    Further improvements to their device may one day improve the effectiveness and safety of chemotherapy in children and adults.

    “It’s really hard for anyone to go through chemotherapy,” said Motamarry. “This is the least that we can do to make it easier for them.”

  • sam patrick posted an article
    Bravery, generosity mark efforts to beat rare disease see more

    When Cortney Gensemer visited her professor during office hours to discuss her Ph.D. dissertation, she had no idea she would be able to study her own disease. 

    Gensemer, a doctoral candidate at the Medical University of South Carolina, first started noticing her symptoms at age 14, when she was forced to sit out the first year of girls varsity lacrosse at her high school in Pennsylvania. She endured numerous joint dislocations and soft tissue tears in both hips before she was diagnosed with hypermobile Ehlers-Danlos syndrome, a rare genetic connective tissue disorder that affects joint and neck movement, at age 19. 

    Prior to her diagnosis and over a year into Division II college lacrosse at West Chester University, she thought her constant injuries meant she just wasn’t as tough as the other athletes on the field. 

    “None of the physical therapists or athletic trainers I was seeing were familiar with EDS,” Gensemer said. ”There was no one saying, ‘This is something bigger.’ ” 

    Now, at age 25, she’s in the last year of her doctoral program at MUSC and recovering from her eighth surgery since being diagnosed. 

    Aside from the gray and blue brace she wore after her most recent surgery to keep the joints in her neck in place, she appeared in good health while working with school lab partners at the end of February. 

    A tattoo of the word “resilience” on her left forearm serves as a reminder to push through moments of severe pain. She calls it her EDS tattoo.

    “It pushes me to want to work hard because I’m literally living with what I’m researching,” Gensemer said. “I’m going to be in awful chronic pain whether I’m sitting on the couch or in the lab.”

    Now, MUSC is on the brink of opening the country’s first Ehlers-Danlos syndrome institute for research, clinical care and education on the disease.

    Symptoms of the hereditary disease range from frequent joint dislocations, joints that extend beyond the normal range, and loose ligaments in the neck and spine. 

    EDS affects roughly 1 in 3,000 people worldwide and so far has 14 different variations. The hypermobile variant is known to be the most common. However, researchers say the real number could include many more since the disease is often undiagnosed or misdiagnosed. Currently there is no cure for EDS. 

    Gensemer is one of the only reasons EDS is being studied at MUSC. Her studies are housed in the Norris Lab, where her professor, Dr. Russell Norris, leads her and a team of 13 researchers and volunteers, some of whom also have EDS. 

    She and the team have so far identified the first strong candidate gene for hypermobile EDS, which could lead to new ways to diagnose patients earlier and more definitively.

    “I didn’t realize how powerful my own story could be,” Gensemer said. “An EDS Institute is something that patients like me have dreamed about our entire lives.”

    Living with EDS
    It can be years before a patient actually confirms they have EDS. And different variants of the disease show up with different symptoms.

    Gensemer was diagnosed within the first five years of exhibiting symptoms, while the average EDS patient waits 10 to 14 years to be properly diagnosed.

    “Hypermobile EDS is really difficult to diagnose because there isn’t a molecular or genetic diagnostic test for it,” Gensemer said. “Identifying this new gene is going to ensure patients aren’t passed around from doctor to doctor or living with vague symptoms for years without knowing what connects them.”

    For most EDS patients, undergoing numerous surgical procedures to reduce chronic pain is a necessity and often the best option for long-lasting relief. 

    Gensemer’s most recent surgery addressed loose ligaments in her neck that couldn’t hold her spine in place. Some doctors say this movement between the neck and head resembles the movement of a bobblehead, causing severe neck pain, sensitivity to light and lingering headaches. 

    To help, doctors fused the vertebrae of her spine together with titanium plates and screws to properly support her head, relieve lingering pain and prevent further symptoms. 

    Gensemer said that before she could undergo surgery, doctors needed to perform an upright MRI to determine what parts of her neck and spine needed support.

    This specific MRI helps to diagnose certain spinal and neck complications of EDS that don’t show up on an MRI scan in the traditional position. 

    However, the nearest upright machine is in Greenville, a nearly four-hour drive. A ride that length can be incredibly painful and in some cases near impossible for people with EDS. 

    That was the case for Sydney Severance, a 16-year-old from Daniel Island, who was diagnosed with EDS in 2020 after months of shuffling back and forth to doctor appointments. 

    Severance’s symptoms left her wheelchair bound, constantly vomiting and extremely sensitive to light. At MUSC, neurological and spinal specialist Dr. Sunil Patel suggested she may be suffering from craniocervical instability, a type of loose ligament condition in EDS that results in injury to the nervous system.

    Finally, she had found a physician who could tell her what was causing her so much pain. But in order to officially diagnose Severance she would need to have an upright MRI scan done, and she wasn’t able to make the drive. Luckily, a family friend of the Severance’s flew them to Greenville privately for the MRI, where her diagnosis was confirmed.

    “It was still excruciating and very difficult to be moved around and have a long day of travel, even though my situation was a lot better than some patients,” Severance said. 

    While Severance agrees that luck was on her side, many others like her who have to drive may turn a four-hour drive into a multiple day trip.

    She recalled talking with an EDS patient who suffered from seizures due to the same loose ligament problem as Severance. The other patient had at least 18 seizures during the trip for their MRI scan. 

    To Severance, the path to diagnosis for patients with this disease is much longer than the drive to Greenville. In fact, some patients go so long without knowing their affliction that it causes severe psychological trauma and confusion regarding the pain they are experiencing.

    So after undergoing her first successful surgery for EDS in 2020, Severance founded Operation Upright, a campaign to raise over $1 million to bring an upright MRI machine to Charleston. 

    Her campaign aims to lessen the average time for diagnosis and give other EDS patients like her a chance at early detection. So far it’s raised over $800,000 out of the $1.2 million goal, including a recent anonymous donation of $600,000. 

    “I was able to get a diagnosis much faster than most people,” Severance said. “I think having an upright MRI machine in Charleston would help a lot of other people reach diagnosis quickly.”

    Gensemer’s research and Severance’s fundraising position them as two of the strongest forces advocating for EDS in the state, fighting for more information and better treatment options for patients across the country and especially within the Lowcountry. 

    Gensemer also developed an EDS patient registry, collecting DNA information from over 3,000 patients nationwide for further genetic research. So far, nearly 80 percent of patients in the registry inherited the disease from a family member.

    According to Norris, the MUSC professor who leads the lab Gensemer works in, the gene they discovered could help doctors decide on the best treatments and physical therapies for patients, and possibly reduce the amount of surgeries a patient undergoes in a lifetime. 

    Now they are testing the theory with animals, transferring the identified gene in humans to mice in their lab in hopes of being able to expand their studies on the disease.  

    “The mice are hypermobile and have changes in connective tissue,” Gensemer said as she carefully held one of the lab mice by the tail. “Now we can use that mouse to expand our studies.”

    While both Gensemer and Severance are currently recovering from surgeries due to complications with EDS, they both say the work they are doing motivates them to keep going. 

    “Fundraising for this upright MRI really keeps me positive because I’m able to turn what has made my life a lot more difficult into something a little more positive,” Severance said. 

    So far, complications from EDS have resulted in Severance relearning to walk at least twice since being diagnosed, and her most recent surgery left her in the hospital for 16 days. 

    “She’s incredibly positive,” said her mother, Ashley Severance. “Even as she was learning how to walk again, she considered herself lucky.”

  • sam patrick posted an article
    A new topic from the Nelson Mullins Idea Exchange see more

    The Centers for Medicare & Medicaid Services (CMS or the Agency) announced on January 19, 2022 that it was delaying the publication of a Clinical Laboratory Improvement Amendments of 1988 (CLIA) final rulemaking by one year.  The goal of this rulemaking is to update clinical laboratory proficiency testing (PT) regulations.  PT is the testing of unknown samples sent to a clinical laboratory by a CMS-approved program.  Such testing is used by CMS, accreditation organizations, and clinical laboratories to verify the accuracy and reliability of a laboratory’s testing activities.

    CMS published the PT proposed rulemaking in February 2019.  Under the Social Security Act, a Medicare final rule must be published within three years of the proposed rule (absent exceptional circumstances).  CMS originally slated the PT final rulemaking for publication in February of this year.  Now, the Agency is expecting finalization of the rule by February 2023.

    The PT rulemaking is intended to address current analytes and newer technologies by updating CLIA regulations (42 CFR Part 493).  In the February 2019 proposed rule, CMS proposed, among other items:

    • Requiring PT for an additional 29 analytes;
    • Mandating a minimum of 10 laboratory participants before a PT program offers an analyte;
    • Increasing the number of challenges per PT event for certain types of testing (e.g., susceptibility or resistance testing for each microbiology subspecialty would increase from one to two challenges); and
    • Requiring that PT programs limit participants’ online submission of PT data to one submission or that a method be provided to track changes made to electronically-reported results.

    CMS received over 100 comments concerning the proposed rulemaking.  In delaying the publication of the final rulemaking by a year, CMS cited the COVID-19 public health emergency.  The Agency is currently prioritizing the “publication of notices relevant to COVID-19 and to provide guidance to laboratories involved in COVID-19 testing.”  Because of these ongoing public health demands, CMS explained that it cannot meet the original February 2022 deadline.

    According to the Fall 2021 Unified Agenda, CMS is scheduled to publish another clinical laboratory-focused proposed rulemaking in March of this year.  That rulemaking will focus on updates to the clinical laboratory personnel, histocompatibility, and alternative sanctions regulations as well as CLIA-related program fees.  Because of the COVID-19 public health emergency, it is unclear if the Agency will postpone publication of this proposed rulemaking as well.

    Nelson Mullins continues to closely monitor developments related to clinical laboratories and CLIA regulations.  For questions or assistance, please contact Christopher Hanson.

  • sam patrick posted an article
    Life sciences firm seeking to add hundreds of new employees see more

    Premier Medical Laboratory Services, has recently reported a rapid increase in medical testing demands coming to their laboratory – the amount of COVID-19 tests alone being processed at their Greenville, SC facility has jumped 250% in the last two weeks. Much of this is due to the Omicron variant, which first made landfall in the US at the beginning of December and is now the dominant strain of the virus in the nation. With this influx of tests poses an immediate need for hundreds of Upstate employees to be hired at the medical laboratory. 

    “Throughout the pandemic we’ve been proactive in fulfilling our staffing needs,” said Kevin Murdock, CEO and Founder of Premier Medical Laboratory Services. “To ensure that we continue to properly meet testing demands amid this new surge, we are looking to vastly expand our team and to provide jobs in the community.”

    PMLS is a CLIA and COLA certified laboratory. They are the choice processing lab for Health and Human Services testing sites, and the trusted COVID-19 management partner for professional sports teams, schools, colleges, large corporations, and health departments across the nation. With an expanding team, they are inviting members of the Upstate community to join them in providing vital services and information, helping to battle COVID-19 and its new variants and to improve the future of healthcare with advanced medical diagnostics. Currently, the lab is looking to fill the following positions:

    Lab Data Entry Clerk

    • NO EXPERIENCE NEEDED
    • Job duties include entering patient information into a computer system, scanning barcodes, and helping with any other lab assistant needs
    • Protective gear and all training are provided by the lab

    Job Type: Part-Time; Pay: $15 per hour

    Medical Laboratory Technician

    Responsible for performing medical tests in the Molecular Lab. Does not need to be certified if a degree in Chemistry or Biology have been attained.

    Responsibilities:

    • Collect and organize blood, tissue, and other bodily fluid samples from patients
    • Prepare samples for routine testing and analysis
    • Properly record results for further analysis and easy reference
    • Monitor inventory samples and supplies
    • Maintain a clean work environment

    Qualifications:

    • You must have experience as a Medical Technologist (ASCP Certificate that is CURRENT is a plus!)
    • BS in Biology or Chemistry is also helpful
    • Familiarity with common medical terminology
    • Experience in a laboratory setting
    • Strong organizational skills

    Job Type: Full-time; Pay: $18-$22 per hour

    Medical Technologist

    Requirements:

    • ***MUST HAVE EXPERIENCE WITH MANUAL EXTRACTION PROCESSES***
    • Has earned a bachelor's degree in a chemical, physical or biological science or medical technology from an accredited institution
    • Has at least 2 years of current laboratory experience, in moderate complexity testing (Chemistry, Hematology, Urinalysis)
    • Has 2 years of laboratory training or experience in high complexity testing (Allergy and/or Molecular)

    Job Type: Full-time; Pay: $24-$28/hr


    All positions located in Greenville, SC. Please email: HR@DIVMEDINC.COM to apply.  For more information, please visit www.PreMedInc.com or call 1.866.800.5470.

    ABOUT PREMIER MEDICAL LABORATORY SERVICES

    Premier Medical Laboratory Services (PMLS), based in Greenville, South Carolina, is an advanced molecular diagnostics lab fully certified by top laboratory accrediting organizations, including CLIA and COLA. With the most advanced laboratory information systems (LIS) easy to read one-page test result reports are generated with higher accuracy and a customizable report for each client. PMLS prides itself on having some of the most rapid turnaround times for testing results in the industry. Their expansive testing menu includes Pharmacogenomics, COVID-19 testing, Advanced Cardiovascular Testing, Diabetes, Women's Wellness panels, Allergen Specific Ige Blood Testing, Toxicology, and a first of its kind predictive genetic test for type II diabetes, DIABETESPredict. For more information, please visit www.PreMedInc.com.

  • sam patrick posted an article
    Challenges in locating lab space impact Palmetto State as well as life sciences hotbeds see more

    Compliments of Axios

    Office occupancy rates remain deflated across industries, but one type of workplace is in high demand: labs.

    The big picture: A number of trends — in public health, American demographics and venture capital funding — are colliding to supercharge the life sciences industry.

    Driving the news: U.S. office vacancy rates are at 17%, but lab vacancy rates are at 5%, according to a new report from the commercial real estate firm CBRE.

    Money is pouring into life sciences companies. Venture capitalists are throwing money at gene editing and other promising therapies, at the same time that an aging American population is driving up health care spending.

    • The annual amount of venture capital flowing to life sciences companies has roughly doubled since 2019 to a whopping $32 billion, per CBRE and CB Insights data in the report.
    • Federal health care spending made up around 4% of GDP in 2006, but that's expected to swell to over 8% by 2040, according to the Congressional Budget Office.

    What's happening: "This was a sector that was white-hot prior to the pandemic," says Jon Varholak, a vice chairman at CBRE who specializes in life sciences real estate. "The pandemic poured more gasoline on the fire."

    • "People now more than ever are realizing we may need to be at the ready for something like this," he says.
    • That's goading established life sciences companies to come up with innovative therapies and vaccines, and giving rise to startups that bring a fresh perspective to public health issues.

    Biotech job openings are growing at their fastest pace on record, outpacing the notoriously hot tech sector, per a CBRE analysis of Bureau of Labor Statistics data.

    Certain metro areas are benefiting from this boom more than others, according to the CBRE report.

    • In Boston, lab vacancies are at 1.7%. Demand for lab space is so high that the city's "office market has become the envy of landlords across the country," the Wall Street Journal's Peter Grant writes.
    • New York's lab vacancy rate is 1.1%, and San Francisco's is 2.6%.

    And here's another new trend: Even though life sciences jobs have traditionally been located outside of cities — where there's ample inexpensive space for big labs and campuses — the strongest demand for lab space is actually in urban areas, says Ian Anderson, CBRE’s head of office research in the Americas.

    • Employment growth between 2017 and 2020 was 25% in Middlesex County, Massachusetts — which is composed of the Greater Boston suburbs — but 35% in Boston proper.
    • Growth was around 18% in San Mateo County, California, but nearly 92% in San Francisco.
    • There's nearly 0% growth in Suffolk County, New York — which encompasses the Long Island suburbs — but over 25% in Manhattan.

    The bottom line: "The whole industry is moving closer to where the intellectual capital is," Anderson says.

  • sam patrick posted an article
    Clinical laboratory investing over $3 million, creating 54 new positions see more

    Luxor Scientific, LLC (Luxor), a full-service clinical laboratory serving customers nationwide, today announced plans to expand operations in Greenville County, South Carolina. The more than $3.2 million investment will create 54 new jobs.

    Luxor is a CLIA and CAP-accredited, and DEA registered full-service clinical laboratory that specializes in infectious disease, immunology, integrated oncology and genetics, chemistry and hematology research. The company is comprised of recognized experts in providing cutting-edge scientific solutions to better serve the health care community.

    “We are excited to continue Luxor Scientific’s growth and investment in Greenville. Our team has established itself as one of the best serving our community, and we are glad to be adding to our capability and to our numbers,” said Luxor Scientific, LLC Chief Strategy Officer Jay Flanagan. “We are ever thankful to Greenville County and the S.C. Department of Commerce for helping us make this expansion a reality.”

    Located at 1327 Miller Road in Greenville, Luxor’s expansion will increase the company’s research and development capacity to better serve its clientele.

    “Luxor’s expansion highlights the tremendous success life science companies are seeing throughout South Carolina,” stated South Carolina Governor Henry McMaster. “This investment will bring enhanced care and innovation to South Carolina’s health care community while also creating high-quality jobs in Greenville County.”

    Luxor was founded in 2016 by brothers Ryan and Jay Flanagan, and has grown to more than 140 employees, including world-class PhD science officers on its staff. Among their clients are S.C. Department of Health and Environmental Control (DHEC), the S.C. Department of Agriculture, the US Drug Enforcement Administration, private sector employers, hospitals, universities, clinics, and others.

    “When companies like Luxor Scientific operate in South Carolina and find success, it highlights the diversity of our state’s economy. We congratulate Luxor on this expansion in Greenville County and look forward to watching their continued work in South Carolina,” added Secretary of Commerce Harry M. Lightsey III.

    The latest expansion is expected to be completed by April 2022. Individuals interested in joining the Luxor team should visit the company’s contact webpage.

    “We are always pleased when a homegrown company like Luxor chooses to expand here in Greenville County, commented Greenville County Council Chairman and Greenville Area Development Corporation Board Member Willis Meadows. “Luxor’s leading-edge expertise in life sciences has made them a strong resource to our state and to communities across the country already, and we are delighted that they have chosen to continue that growth from right here in Greenville County.”

    # # #

    The Greenville Area Development Corporation is a non-profit organization established by Greenville County Council to promote and enhance the economic growth and development of Greenville County. Since its founding in 2001, GADC efforts have resulted in the creation of over 30,000 new jobs, nearly $6 billion in capital investment, and a cumulative economic impact of over $55 billion in Greenville County, SC -- including an economic impact of more than $6 billion annually. To learn more, please visit www.goGADC.com or call (864) 235-2008. To learn more about workforce opportunities, visit www.jobsingreenvillesc.com.