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  • 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
    Will identify and advance therapies for genetic diseases and cancers see more

    BridgeBio Pharma, Inc. (Nasdaq: BBIO), a commercial-stage biopharmaceutical company founded to discover, create, test and deliver meaningful medicines for patients with genetic diseases and cancers with clear genetic drivers, today announced three new academic collaborations with MUSC Foundation for Research Development, Stanford University and the University of Pittsburgh (Pitt) to translate cutting-edge discoveries into potential therapies for patients with genetic diseases and genetically driven cancers.

    "The chance to partner with exceptional researchers at the Medical University of South Carolina, Stanford University and University of Pittsburgh is a privilege, and we believe will help us advance our mission to discover, create, test and deliver life-changing medicines for patients in need as rapidly as possible," said BridgeBio founder and CEO Neil Kumar, Ph.D.

    To date, BridgeBio has worked with 23 leading institutions throughout the country that are focused on providing treatment options to patients as quickly and safely as possible. For a list of some of the institutions BridgeBio is partnered with, please visit Our Partners page.

    MUSC Foundation for Research Development
    MUSC Foundation for Research Development provides technology transfer services to Medical University of South Carolina (MUSC), which is a patient-centric research institution with several hospitals in South Carolina and is considered the state's top healthcare provider. MUSC's innovative and high-quality research will allow for early identification of research programs with a strong potential to be beneficial for patients. Through this partnership, BridgeBio may sponsor research programs and support the development of identified programs toward potential clinical investigation through its licensing and affiliate development model.

    "Like BridgeBio, we have a patients first mentality, so partnering together on early research will be an excellent opportunity to advance our innovation in the hope of generating new therapies for patients," said Scott Davis, Ph.D., senior director of innovation support and commercialization of MUSC Foundation for Research Development.

    About BridgeBio Pharma, Inc.
    BridgeBio Pharma (BridgeBio) is a biopharmaceutical company founded to discover, create, test and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. BridgeBio's pipeline of over 30 development programs ranges from early science to advanced clinical trials and its commercial organization is focused on delivering the company's first two approved therapies. BridgeBio was founded in 2015 and its team of experienced drug discoverers, developers and innovators are committed to applying advances in genetic medicine to help patients as quickly as possible. For more information visit bridgebio.com.

  • sam patrick posted an article
    Validated platform with clinically actionable results creates real possibilities to improve care see more

    Validated platform with clinically actionable results creates real possibilities to improve care for glioblastoma (GBM) and other high-grade glioma patients

     

    GREENVILLE, S.C. – June 17, 2021 – KIYATEC, Inc. announced today the publication of new peer-reviewed data that establishes clinically meaningful prediction of patient-specific responses to standard of care therapy, prior to treatment, in newly diagnosed glioblastoma (GBM) and other high-grade glioma (HGG) patients. The results, the interim data analysis of the company’s 3D-PREDICT clinical study, were published June 16, 2021 in Neuro-Oncology Advances, an open access clinical journal.

    A goal of the study, which continues to enroll, was for the test’s prospective, patient-specific response prediction to achieve statistical significance for predictive accuracy. The 3D-PREDICT study met this goal early, at its interim data analysis, an achievement that is uncommon for innovations in oncology. For clinicians and payors, the publication establishes the successful analytical validation and early clinical validation of KIYATEC’s 3D Predict™ Glioma assay.

    The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the severity of this aggressive brain cancer. Fewer than 10% of patients survive longer than five years. Pharmaceutical and clinical efforts have only resulted in modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen (radiation therapy and temozolomide), presenting an opportunity to improve care through shifting the paradigm toward individualized medicine for HGG treatment.

    KIYATEC’s test results accurately identified the patients as future temozolomide responders or future non-responders prior to the initiation of drug treatment. The future responder group had a statistically significant 6-month comparative increase in overall survival. Since test results are available only seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, KIYATEC’s results may also prove useful to improve outcomes for each predicted responder through patient-specific combination strategies.

    Successful response-prediction for newly diagnosed patients follows the company’s previous success with predicting treatment response in recurrent high-grade glioma patients. In December 2020, KIYATEC announced a clinical case series demonstrating that use of their test doubled these patients’ median time to progression over what would be expected without use of the test. In addition, the earlier announcement demonstrated successful clinical use of the targeted agent dabrafenib in two patients that were not identified by genetic sequencing. By identifying successful response to drugs that would have been missed by today’s testing, KIYATEC’s results expanded the successful treatment options for these patients.

    “Decision making in our framework is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is administered creates options that were not previously available when it comes to treatment,” said Matthew Gevaert, PhD, CEO of KIYATEC.

    Versus other approaches, tests developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In newly diagnosed ovarian cancer patients, KIYATEC’s test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.

    About KIYATEC
    KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The platforms are positioned to address the gap-defining limitations of current cancer drug selection. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. 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
    Greenwood Genetic Center project receives grant to expand access for genetics services see more

    The Greenwood Genetic Center (GGC), through the Self Regional Healthcare Foundation, has been awarded a grant of $899,000 from The Duke Endowment for 'Genetics Access for All,' a project to expand access to genetics services for patients and providers.

    "In this current era of genomic medicine, there is an increasing demand for clinical genetics services, but our workforce is insufficient to meet this demand, and our current work flows are inefficient," said Mike Lyons, MD, Director of Clinical Services at GGC and lead on the funded project. "This leads to families facing long waits to be evaluated and tested, and subsequent delays in managing and treating their child's condition."

    GGC has provided clinical genetics services since 1974; however, with the increase in demand for services, and inability of genetics training programs to keep up with the ensuing workforce demand, patients often wait for six months or longer to be seen.

    "This is not just a GGC issue. Genetics clinics around the country are facing wait times that are as long or longer than ours," said Steve Skinner, MD, GGC Director. "And we have found that as genomic technology has been evolving at such a rapid pace, many non-genetics providers do not feel comfortable ordering and interpreting genetic tests on their own."

    'Genetics Access for All' proposes a new standard of genetics care by optimizing access for patients and employing a new system of communication to transform how non-genetics providers engage with genetics providers in order to better manage their patients.

    In 2019, GGC and the Medical University of South Carolina (MUSC) signed an affiliation agreement with the goal of improving access to genetic services for patients across SC.

    One initiative that has grown out of this affiliation is a pilot project with the MUSC Center for Telehealth to develop an electronic consult (e-consult) system for genetics referrals. The project initially offered the option only to a limited number of referring providers in the MUSC system. Funding from The Duke Endowment will allow that project to expand on a much larger scale.

    During the first year of the funded project, GGC will implement e-consults through an online platform to allow non-genetics providers to upload patient information, and receive clinical impressions and testing recommendations within two business days. E-consults will help avoid unnecessary referrals, improve communication with non-genetic providers, and enhance efficiency by decreasing the amount of time needed for in-person and telemedicine visits.

    In year two, GGC plans to expand the concept to provide electronic patient visits (e-visits) allowing patients to upload their information electronically and quickly receive clinical feedback and recommendations. The goal of e-visits is not to replace in-person or telegenetics visits, but to provide another care option that improves communication with and access for patients.

    Lyons says that the ultimate goal of this project is to change the model of genetics care from a long diagnostic odyssey to a more efficient system that decreases unnecessary referrals, expedites diagnoses, and decreases wait times for appointments.

    "Through e-consults, we'll be able to more quickly identify patients who need genetic testing and facilitate the appropriate testing," he said. "A rapid diagnosis will allow for more timely and precise management and treatment for all patients impacted by a genetic disorder."

    GGC expects to see significant improvements in patient care as the project expands. "Our goals are to complete 50 outpatient and 25 inpatient e-consults and 25 e-visits per month by the end of the grant cycle," said Lyons. "We anticipate this project to dramatically improve wait times for all types of visits, and hope that our success can be translated into a new model for genetics care in clinics nationwide."

     

    About Greenwood Genetic Center

    The Greenwood Genetic Center (GGC), founded in 1974, is a nonprofit organization advancing the field of medical genetics and caring for families impacted by genetic disease and birth defects.  At its home campus in Greenwood, South Carolina, a talented team of physicians and scientists provides clinical genetic services, diagnostic laboratory testing, educational programs and resources, and research in the field of medical genetics.  GGC’s faculty and staff are committed to the goal of developing preventive and curative therapies for the individuals and families they serve.  GGC extends its reach as a resource to all residents of South Carolina with satellite offices in Charleston, Columbia, Florence and Greenville. For more information about GGC please visit www.ggc.org.

     

    About The Duke Endowment

    Based in Charlotte and established in 1924 by industrialist and philanthropist James B. Duke, The Duke Endowment is a private foundation that strengthens communities in North Carolina and South Carolina by nurturing children, promoting health, educating minds and enriching spirits. Since its founding, it has distributed more than $4 billion in grants. The Endowment shares a name with Duke University and Duke Energy, but all are separate organizations.

  • sam patrick posted an article
    First release of 3D-PREDICT clinical study data fuels momentum of company’s glioblastoma program see more

    GREENVILLE, SC – December 17, 2020 – KIYATEC, Inc. today announced the first clinical use of its response-prediction test to improve outcomes in relapsed brain cancer patients. Test results that measure the effect of cancer drugs on a patient’s live cancer cells are available in just seven days, thereby enabling oncologists to select drugs informed by patient-specific evidence of response before treatment begins.

    Lindsay Lipinski, MD, Assistant Professor of Oncology and a neurosurgeon at Roswell Park Comprehensive Cancer Center (Buffalo, NY), presented her and her colleagues’ findings at the 2020 Society of Neuro-Oncology meeting in November. A case series of seven patients with recurrent high-grade gliomas – six with glioblastoma multiforme (GBM) and one with anaplastic astrocytoma – was detailed.

    “In this early experience, tools that can predict a tumor cell’s responsivity to a variety of chemotherapy or other therapeutic agents have already been extremely valuable in guiding treatment decision-making for patients with recurrent high-grade gliomas at our center,” said Dr. Lipinski. “Our results show that we are far along in the paradigm shift toward individualized medicine.”

    Today, when these cancers return following a patient’s initial treatment, oncologists do not have evidence-based guidelines to choose which drug therapy to use next. Across several drug options, the typical expectation for the time in which these recurrent patients will remain cancer-free (i.e., median progression free survival or PFS) is only 4 months. The use of KIYATEC’s test results to inform drug selection approximately doubled the typical expectation, achieving a group median PFS of 7.9 months, a significant improvement over expected PFS in these patients.

    KIYATEC’s test results informed two of the seven patients’ successful treatment with dabrafenib, a targeted agent. Notably, neither had a typically associated genetic mutation, demonstrating that the test can uncover effective drug options that would have normally been missed.

    “Our vision is to successfully translate these study findings into the GBM population at large, including newly diagnosed patients – a population that we’re also actively enrolling and testing in our study,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Today’s positive results in relapsed patients, with a median age of 60 and some having had two or even three relapses, paves the way to do this.” 

    This first release of data from KIYATEC’s active 3D-PREDICT (ClinicalTrials.gov ID NCT03561207) clinical study coincides with the continued addition of new sites at which high-grade glioma patients can enroll, bringing this study to nine institutions across the United States.
     

    About KIYATEC, Inc.
    KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. 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.

     

    Citation:

    Lindsay Lipinski, et al., INNV-16. Clinical applicability of individualized drug response profiling utilizing ex-vivo tissue-derived 3D cell culture assays in high-grade glioma: a single institution case series using 3D-PREDICT results, Neuro-Oncology, Volume 22, Issue Supplement_2, November 2020, Pages ii119–ii120, https://doi.org/10.1093/neuonc/noaa215.499.

     

  • sam patrick posted an article
    U.S. News & World Report releases annual national rankings see more

    MUSC Health University Medical Center in Charleston was named by U.S. News & World Report for the sixth year in a row as the No. 1 hospital in South Carolina, with three of the MUSC Health,  Charleston Division, specialty areas ranking among the best in the entire country: ear, nose and throat; gynecology; and cancer. Six other MUSC Health programs based in Charleston are considered “high performing” in the 2020-2021 U.S. News & World Report rankings: gastroenterology and GI surgery; nephrology; neurology and neurosurgery; orthopedics; rheumatology and urology. In addition, MUSC Health Florence Medical Center is designated “high performing” in chronic obstructive pulmonary disease (COPD) and heart failure, and MUSC Health Lancaster Medical Center is designated  “high performing” in COPD and heart failure.

    “These six consecutive years of recognition demonstrate that our teams remain committed to keeping the needs of patients as the focal points of what we deliver every day,” said Patrick J. Cawley, M.D., MUSC Health CEO and vice president for Health Affairs, University. “With all the pressures bearing on the health care industry right now, especially during this pandemic, yet again earning this level of recognition as the leading health care organization in the Charleston area, the Lowcountry and the state engenders a tremendous sense of accomplishment and pride in our teams’ abilities to change what’s possible for those we serve.”

    The Best Hospitals 2020-2021 https://health.usnews.com/best-hospitals report is designed to help patients with life-threatening or rare conditions identify hospitals that excel in treating the most difficult cases. The annual report includes consumer-friendly data and information on 4,500 medical centers nationwide in 16 specialties, 10 procedures and conditions. In the 16 specialty areas, 134 hospitals were ranked in at least one specialty. In rankings by state and metro area, U.S. News & World Report recognizes hospitals as high performing across multiple areas of care.

    “It is particularly gratifying to see two of the newest hospitals within the MUSC Health system, in our Florence and Lancaster Divisions, recognized in this year’s report,” Cawley said. “Our teams statewide are engaged in delivering health care that is built on quality, safety and innovation at every level.” The Florence and Lancaster hospitals joined the MUSC Health system in March 2019 when MUSC Health acquired four community hospitals.

    The U.S. News & World Report Best Hospitals methodologies, in most areas of care, are based largely or entirely on objective measures such as risk-adjusted survival and readmission rates, volume, patient experience, patient safety and quality of nursing, among other care-related indicators.

    “For more than 30 years, U.S. News & World Report has been helping patients, along with the help of their physicians, identify the Best Hospitals in an array of specialties, procedures and conditions,” said Ben Harder, managing editor and chief of health analysis at U.S. News. “The hospitals that rise to the top of our rankings and ratings have deep medical expertise, and each has built a track record of delivering good outcomes for patients.”

    U.S. News & World Report produces its Best Hospitals rankings with RTI International, a leading research organization based in Research Triangle Park, N.C.

  • sam patrick posted an article
    KIYATEC adds to its Board of Directors see more

    KIYATEC, Inc. today announced the appointment of Bruce Nash, MD, MBA, to its Board of Directors. Dr. Nash brings over 30 years of executive-level healthcare experience in the managed care, hospital and medical group practice settings. Currently, he serves as Chief Physician Executive and Senior Vice President at Blue Cross Blue Shield of Massachusetts, one of the nation’s leading health insurance plans. During his career, Dr. Nash has held executive leadership positions in both managed care (Kaiser Permanente, Capital District Physicians’ Health Plan) and healthcare (Northern Berkshire Health System, North Adams Regional Hospital) organizations. 

    Dr. Nash serves on the boards of the Blue Cross Blue Shield Foundation and the Network for Excellence in Health Innovation (NEHI), while also serving on the Board of Strategic Advisors at the Excel Venture Management Fund and the Clinical Advisory Group at the Blue Venture Fund.  He is a board-certified physician who completed his residency training at Duke University. Bruce earned his MBA in Health Sector Management from Duke University's Fuqua School of Business.

    “We are delighted to welcome Dr. Nash to KIYATEC’s Board of Directors,” said Robert Silverman, Chairman of the Board of Directors of KIYATEC. “Bruce’s relevant experience and vision as both a clinician and an expert in managed care will provide tremendous value as KIYATEC moves forward in the development of our predictive clinical tests to improve cancer patient care and outcomes.”

    The addition of Dr. Nash to the KIYATEC Board of Directors comes as the company’s evidence development efforts continue to gain momentum:

     

    About KIYATEC, Inc.

    KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory.  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
    KIYATEC growth supports upcoming programs to better predict patient response to oncology drugs see more

    GREENVILLE, SC. – May 29, 2018 – KIYATEC, Inc., a privately held company changing the future of cancer care by predicting patient response to oncology drugs prior to treatment, today announced an expansion of its leadership team with the appointment of two industry veterans. Charlene Knape has joined the company as Vice President of Clinical Affairs, and Timothy Decker as Vice President Commercial Operations.

    Mr. Decker, a twenty year industry leader with a proven track record of developing and commercializing oncology diagnostic services and pharmaceuticals, has assumed responsibility for pre-launch commercial strategic development along with tactical planning and execution to drive clinical product launches. Mr. Decker held roles of increasing responsibility in strategic and tactical marketing for a decade at G.D. Searle and Abbott Laboratories before joining Genomic Health, Inc.  Over an eight year span, he played a lead role as Director and Senior Director in the global launch, marketing, reimbursement and sales of Oncotype DX molecular diagnostic tests in breast, colon and prostate cancers. Mr. Decker subsequently served as Vice President of Marketing at Castle Biosciences, Inc., where he drove corporate and pipeline strategy, as well as in-line product strategy and revenue growth for its molecular diagnostic tests in melanoma. He joins the company from Mexico City-based Grupo Fármacos Especializados, where he served as Division Head, Oncology Diagnostics, responsible for developing reimbursement pathways and securing positive coverage decisions among public and private sector payers.

    With more than 25 years of experience working with diagnostic companies, Ms. Knape is responsible for leading the clinical development programs and clinical operations for KIYATEC’s pipeline for ovarian cancer, glioblastoma, rare tumors and triple negative breast cancer. She most recently served as Senior Director, Clinical Development for Inivata, a clinical cancer genomics company utilizing liquid biopsies for comprehensive genomic profiling of tumors. Prior to this, Ms. Knape served in Becton Dickinson’s Corporate Clinical Development group, responsible for global clinical quality and contracts. Ms. Knape spent five years with Micell Technologies as Senior Director of Clinical Affairs where she managed all global clinical activities for first-in-human and CE Marking studies for an implantable cardiovascular device from initiation through successful regulatory submission. As the company’s lead in clinical operations, Ms. Knape also built the team and initiated a 1,400-patient study in Europe and a 400-patient study in China. Previously, Ms. Knape served as Vice President, Clinical Affairs at EndoTex Interventional Systems, led the clinical functions for Avocet Medical and Somnus Medical Technologies and held clinical affairs positions in the Companion Diagnostics and Biorepository at LabCorp.

    “At this pivotal time in the company’s growth, we are thrilled to welcome Charlene and Tim to KIYATEC. These two newly created positions are critical as we expand our clinical programs in key therapeutic areas and further strengthen our plan for the broad adoption of our patient-specific response prediction tests,” said Dr. Matthew Gevaert, CEO of KIYATEC. “Their expertise and industry knowledge is unparalleled and they will be instrumental as KIYATEC continues toward its path of changing the future of cancer care by predicting patient response to chemotherapy before treatment begins. I’m so glad to have Tim and Charlene on our team as we move toward our goal of commercialization and helping patients receive optimal treatment at the earliest possible time.”

    KIYATEC will be attending the American Society of Clinical Oncology (ASCO) meeting being held June 1-5 in Chicago.

    About KIYATEC, Inc.

    KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to chemotherapy drugs before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to accurately predict treatment response prior to beginning treatment.