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precision medicine

  • sam patrick posted an article
    New DNA-based approach may be wave of the future see more

    Compliments of Greenville Business Magazine

    If your doctor knew your risk for colon cancer or heart disease years before the disease developed, he or she could help you take steps to prevent it.

    And by collecting DNA samples from thousands of South Carolinians, the Medical University of South Carolina is embarking on a project which hopes to do just that. 

    In the initiative, which stakeholders call the first of its kind in the state, MUSC is partnering with population genomics company Helix to study DNA to drive a concept known as precision medicine. It allows providers and patients to develop health care plans with a more preventive approach.

    The power in precision medicine cannot be overstated, said Dr. Lori McMahon, vice president and associate provost for research at MUSC.

    “Genes are what make us who we are,” she told Integrated Media, publisher of Greenville Business Magazine, Columbia Business Monthly and Charleston Business Magazine. 

    “What we learn here … will influence care for individuals across the country and across the globe.” 

    The earlier genes associated with a disease are found, the better the chances of successful treatment, said Dr. Dan Judge, professor of medicine and cardiology at MUSC and director of cardiovascular genetics.

    Theoretically, this concept might have helped “Black Panther” star and Anderson, S.C., native Chadwick Boseman, he said.

    Boseman died last year of colon cancer at the age of 43, seven years before traditional colonoscopy screening typically begins, he said. 

    Had he learned through DNA testing that he had a propensity to develop the disease, that screening could have begun much earlier, perhaps in time to keep the cancer from progressing, he said.

    And a woman with a genetic predisposition to breast cancer might begin mammograms at an earlier age or get more sensitive MRIs instead, Judge said.

    “We hope we’ll be saving lives with this project,” he said. “That’s really the bottom line.”

    The project will focus on certain forms of cancer and cardiovascular disease initially, but hopes to expand to other diseases in time, McMahon said.

    Called “In Our DNA SC,” the project hopes to enlist 100,000 South Carolina adults – 25,000 a year for four years, Judge said.

    The initiative will start with MUSC patients who already have an electronic health record and an upcoming appointment, he said. They will get a message through MyChart to let them know they’re eligible. Later, it will expand across South Carolina.

    “It won’t be something that private physicians can order directly,” he said. “This program requires people to sign up through a review board process so that it’s gone through protocol, and safety and confidentiality issues are all addressed.”

    Similar programs have identified as many as one in 75 participants who were at risk for a serious health issue, 90 percent of which would not have been discovered through traditional practice, said Dr. James Lu, CEO and co-founder of California-based Helix, which describes itself as a population genomics company at the intersection of clinical care, research and genomics.

    “By expanding access and making genomic data actionable for health care providers,” he said, “we will be able to work in tandem with MUSC … to identify risk earlier and prevent or mitigate serious diseases for its community and beyond.”

    The popularity of companies like 23andme shows that people want to understand their genetics, McMahon said.

    “People are even buying DNA kits for their dogs,” she said.

    The genetic test is free to participants and involves only a saliva sample.

    Genetic counseling will be provided to patients whose DNA reveals a risk for disease so there can be further discussion of what it means for the patient and for family members who might be at risk as well, he said.

    In addition to the clinical component, the project has a research component that will develop a dataset to advance genomics research.

    It also will examine how genetic changes influence the development and progression of disease, McMahon said, and help in the development of new and better therapeutics. 

    For instance, some people respond to certain blood pressure medications while others don’t, but it’s not understood why.

    “This will help us try to understand the genetic basis for that,” she said, “and who may need alternate therapy.” 

    Caroline Brown, chief of external affairs at MUSC, said the hospital system and Helix took steps to ensure that patient data are secure. While the results are linked to the patient’s medical record so his provider has access to them, the information is de-identified for research purposes, she said.

    The genetic results will be entered into the participants’ medical records, like a chest X-ray or MRI results are, where they are available to insurers, Judge said.

    While there is a law called the Genetic Information Nondiscrimination Act that protects people from health insurance or employment discrimination on the basis of genetics, information in medical records can be used to deny life insurance or charge more for it, he said. Patients will be informed of that as part of the consent form for participation, he said.

    Brown said that as a state academic medical center, MUSC is focused on building its genomics prowess to ensure it can be a leader in precision medicine in the future. It chose to partner with Helix because of its established data analytics platform which is capable of large-scale projects like this, she said.

    “MUSC looked for a strategic partner to offer genetic testing that can be provided to the patient and his provider so they better know how their genetic makeup impacts their health,” she said. 

    MUSC has identified funding for the program, Brown said, but she declined to divulge the cost.

    McMahon said that when patients and providers are armed with genetic information, they can make better decisions about care going forward and push health care to a new level.

    “This is the way of the future,” she said.

    And Judge said he expects it will likely be routine within 20 years. 

  • sam patrick posted an article
    Expanded use of test builds on previous month’s publication of successful interim clinical data see more

    Functional precision oncology innovator Kiyatec announced today that it is initiating use of the 3D Predict™ Glioma test outside of its 3D-PREDICT clinical study. Recently published peer-reviewed data demonstrated successful use of this test for patients with either newly diagnosed or recurrent high-grade gliomas, which includes glioblastoma (GBM).

    In choosing July 21, 2021, to announce the expanded use of its test, KIYATEC joins the country in shining a light on glioblastoma, which is the most common, treatment-resistant, and deadliest type of brain cancer. A recent bipartisan U.S. Senate resolution declared today as Glioblastoma Awareness Day in order to highlight the severity of GBM, and show support for individuals who are currently living with GBM, as well as caregivers and families. Additionally, the resolution encourages continued investment into glioblastoma research and treatments.

    “At the core of KIYATEC’s mission is the desire to improve cancer patients’ lives. We’re excited to take the next step in fulfilling this mission by expanding the use of our testing for patients with GBM, which is such an aggressive cancer with few treatment options,” said Lillia Holmes, Chief Operations Officer at KIYATEC.

    In a patient, the biological interaction between their live cancer cells and the administered therapy drives treatment outcomes. Measurement of this interaction, before prescribing a treatment plan, is not typically part of today’s cancer treatment paradigm. KIYATEC’s test results add this measurement into the information that informs oncologists’ treatment decisions for a given patient. This approach translated to patient benefit while demonstrating clinically relevant accuracy, as documented in the June Neuro-Oncology Advances publication.

    The 3D Predict™ Glioma test is designed to work within the current framework of standard of care for high-grade glioma patients. Since live cells are required for the test, a patient’s oncologist must sync sample submission with the timing of the first surgery for newly diagnosed patients, or recurrent surgeries for relapsed patients. Oncologists interested in the potential use of the test to inform their decision-making, or requesting test kits to provide samples, should contact the company at medical.affairs@kiyatec.com.

    “Our goal is to provide oncologists with a more effective decision-making tool, by combining individual patient’s cancer cells with potential treatment drugs,” said Stephen Shuford, first author on the company’s recent Neuro-Oncology Advances publication.

    The Senate resolution recognizes that:

    • The five-year survival rate for GBM patients is 7%,
    • The median length of survival is 8 months,
    • Approximately 13,000 Americans will be diagnosed with GBM in 2021,
    • Brain cancer has the highest per-patient initial cost of care, and
    • Despite being first described over a century ago, there are only four FDA approved drugs and one device for GBM.

    KIYATEC aims to make a meaningful impact for patients who are facing this challenging cancer.

    About KIYATEC

    KIYATEC is a functional precision oncology company that measures the response of each patient’s live cancer cells to inform oncologists’ treatment selection decisions. The company’s Clinical Services business offers or is developing clinical tests for high-grade glioma, ovarian, breast, and non-small cell lung cancers, and rare tumors in its CLIA-certified lab. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

  • sam patrick posted an article
    COVID testing expands in workplace see more

    Courtesy of GSA Business Report & Molly Hulsey

    As industry begins to reopen across the state, life science companies turn their sights to expanding COVID-19 diagnostic and antibody testing options for the workplace.

    Greenville-based lab Precision Genetics partnered with Prisma Health in early April to process the health care system’s COVID-19 tests within 24-hours of reaching the lab.

    Now that this testing line is fully automated with the capacity to churn out about 1,000 samples in a matter of hours, the lab is developing plans for the next testing battleground with a high-throughput COVID-19 diagnostic program called “Precision Worker Safety” and a smartphone employee wellness app created by Questis that uses an RFID thermometer to report feverish temperatures to employers.

    “Up here in Greenville, manufacturing is a huge, huge part of our economic situation, so we have to be able to provide employers some kind of assurance that their employees can come back to work without a rapid spread of the virus,” Nate Wilbourne, CEO and president of Precision Genetics said, adding that it is “naive” to think the state peaked in mid-April with so little testing.

    He said Precision is working with several large self-insured manufacturing companies as well as poultry suppliers to develop a salvia-based testing strategy. Pending a state-supported grant that the lab applied for during the week of May 1, Precision will launch saliva-based testing within three weeks.

    Other methods of testing face a waiting period before they can be implemented, while the app is several months away from release, he said.

    “What we’ve developed is a combination approach to COVID-19 screening and an antibody test as it evolves, as the workforce is building up an immunity at the individual level, which reduces the spread over time,” he said. “Until there’s a vaccine or some type of therapy, that is the safest way to go about this.”

    In late April, however, Wilbourne said current antibody tests led to a number of false positives and negatives.

    “Unfortunately, antibody testing is not very reliable today, as it sits,” he said. “There are still a lot of gaps in the science regarding the sensitivities and specifications. Right now, there are 50 proteins in the coronavirus. Right now, we (the health science community) are testing for multiple proteins, but there’s no way to guarantee which protein creates immunity.”

    He also said antibody testing can only detect antibodies a few weeks after individuals have recovered from COVID-19 but noted that the work of professionals like Dr. John Wrangle, Precision’s chief medical officer and medical oncologist at the Medical University of South Carolina, are heading up research to broaden the window of antibody detection and accuracy of the tests.

    Sam Konduros, CEO and president of SCBio, said the life sciences economic development network is working to support continued research and implementation of both diagnostic and antibody testing across the state.

    “Even from the beginning, we were trying to present every approved and available COVID-19 test kit option we were aware of, and as you can imagine, we are moving heavily into the world of antibody testing now too,” he said. Our primary goal in representing the life sciences industry in the state is to have a very ecumenical approach of what resources are available that can help employers reopen as safely as possible if working remotely is not an option.”

    One way SCBio hopes to open those options to employers is making test kits readily available to state industries through the COVID-19 Emergency Supply Collaborative that SCBio helped develop with the S.C. Manufacturers Extension Partnership, the S.C. Hospital Association and S.C. Department of Commerce.

    Created in early April with the goal of bridging shortages in personal protective equipment and other critical needs goods to health care systems, Konduros said the online portal also welcomes purchases from businesses, especially manufacturers, in need of South Carolina-made masks, disinfectant, test kits or a host of other high-demand products.

    On April 7, Konduros also noted that antibody testing tended to be a less reliable indicator than diagnostic testing at this point, but he sees potential for companies to use both, especially as antibody testing becomes more sophisticated and “herd immunity” builds.

    “From a diagnostic standpoint, there doesn’t seem to be a substitution for PCR testing, which is going to be the one way to confirm a diagnosis for someone with COVID-19, either someone who is showing acute symptoms or has had clear exposure, or is working in an environment where an employer would simply need to know there is that issue,” he said.

    On the other hand, Konduros is intrigued by the potential of workforce antibody testing as research moves forward, especially with tests used by Abbott Laboratories,  that detect IgG antibodies that remain in the bloodstream for several weeks after an individual recovers from COVID-19. He said that as the state moves into summer, Abbott is planning to release large quantities of IgG tests that are at least 98% accurate.

    “I certainly think the antibody tests are going to innovate and improve over time, and there’s going to be a lot more data to see how people are responding who have had COVID-19 and what kind of immunity is being developed. There are just so many variables right now,” Konduros said.

  • sam patrick posted an article
    MUSC, Siemens Healthineers craft extraordinary agreement to advance healthcare see more

    The Medical University of South Carolina and Siemens Healthineers have formed a first-of-its-kind strategic partnership with the mutual goal of advancing the quality of health care in South Carolina. The partnership will capitalize on the coupling of MUSC’s clinical care, research and education expertise with Siemens Healthineers’ engineering innovations and workflow-improvement capabilities.

    “We are leveraging a longstanding relationship to reshape what we can both deliver in health care,” said David J. Cole, M.D., MUSC president. “Our nation is demanding that we address our fractured, costly and inefficient health care delivery systems. As the leading academic health sciences center in this state, MUSC’s purpose must be to drive the highest quality care for our patients at the lowest cost through commitment and partnerships. In discussions with the Siemens Healthineers team, we discovered a high degree of alignment with these concepts, and we are very excited to have them move forward with us. Our mutual goal is to not merely provide the best care possible for just our patients; we will define the new gold standard for others to follow.”

    Specifically, this new agreement will focus on driving performance excellence at MUSC and generating significant clinical and value-driven innovations in focused target areas including pediatrics, cardiovascular care, radiology, and neurosciences.

    “Ultimately, our goal is to enable health care providers to get better outcomes at lower cost. We will achieve that by empowering MUSC clinicians on this journey through four specific areas of focus – expanding precision medicine, transforming care delivery, improving the patient experience, and digitalizing health care,” said Dave Pacitti, president of North America for Siemens Healthineers. “These four core values of Siemens Healthineers are representative of the goals of our strategic relationship with MUSC, and we hope that the spirit of this flagship partnership will initiate a trend in value based care within the industry.”

     

    Read the entire article by clicking here.