investigational cancer drugs

  • sam patrick posted an article
    Company making up to 71,000 RNA extractions available to testing laboratories see more

    GREENVILLE, S.C. – April 1, 2020 – KIYATEC, Inc., a clinical-stage leader in ex vivo 3D cell culture testing that supports cancer drug development and drug therapy decision-making, announced today that it is making high-throughput RNA extraction services available to clinical laboratories nationwide that are conducting COVID-19 testing. By creating additional capacity for RNA extraction, a critical component of the COVID-19 testing process, KIYATEC believes it will help testing laboratories normalize the processing and delivery of test results at a time of unprecedented testing demand and turnaround times.

    Most coronavirus tests rely on RNA extraction as the first technical step; without it, the test cannot be performed. Nationwide shortages and backlogs in the reagents and kits most often used to perform these extractions have created bottlenecks and delays that have impacted COVID-19 testing volume and throughput, thereby prompting the U.S. Food and Drug Administration (FDA) to approve alternate testing processes under Emergency Use Authorization (EAU) status. With an already CLIA-certified and operational high complexity lab, KIYATEC is joining the fight against this pandemic by offering its RNA extraction services to COVID-19 testing laboratories.

    While KIYATEC’s core business in oncology continues to occupy much of its laboratory testing capacity, the company has elected to make up to 71,000 RNA extractions available over the next two months, effective immediately, on a fee-for-service basis to COVID-19 testing laboratories nationwide. At a time when COVID-19 testing volume and turnaround times are surging, KIYATEC’s 24-hour turnaround time per RNA extraction could provide a cost-effective efficiency boost to laboratories performing these tests. Making RNA extraction services available to COVID-19 testing laboratories is consistent with KIYATEC’s core goals of improving patient care and outcomes.

    “Although KIYATEC traditionally serves the oncology community exclusively, we quickly determined that our existing technical infrastructure and capabilities in RNA extraction were ideally aligned to address this critical pressure point in the COVID-19 test process,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Following discussions with public health thought leaders and COVID-19 testing laboratories, we realized that offering RNA extraction services could provide immediate help to these laboratories in overcoming possible supply chain challenges and optimizing their volume and turnaround time potential.”

    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.

    Contacts

    KIYATEC Inc.
    Lillia Holmes, Chief Operating Officer, 864-502-2013
    customer.service@Kiyatec.com
    www.kiyatec.com

  • sam patrick posted an article
    KIYATEC advances published in Scientific Reports see more

    KIYATEC, Inc. today announces that results from its prospective, multi-center pilot study, to investigate their assay’s predictive accuracy and correlation to outcome among newly diagnosed ovarian cancer patients, have been published in Scientific Reports. Study findings represent both a preliminary clinical validation for the company’s ovarian cancer assay and a significant developmental milestone for the assay’s technology platform, known as Ex Vivo 3D Cell Culture (EV3D).

    “For ovarian cancer patients and their physicians, this study represents an important step in demonstrating our ability to deliver a robust predictive assay with the potential to positively support therapeutic decision-making and improve patient outcomes,” said Matthew Gevaert, CEO of KIYATEC. “Our mission is to optimize and leverage our EV3D cell culture technology to develop response-predictive clinical assays across a range of solid tumor types and make a difference in the future of cancer care.”

    In the study, primary tissue from 92 newly diagnosed ovarian cancer patients were prospectively collected and tested for response to National Comprehensive Cancer Network (NCCN)-recommended frontline chemotherapy drugs at KIYATEC’s central laboratory. Assay results were successfully generated for 83 (90%) patient samples. All 92 patients received standard of care chemotherapy (80% adjuvant, 20% neoadjuvant) independent of the KIYATEC drug response prediction test result.

    A total of 44 patients (of the 83 patients tested) met minimum follow-up time of 6 months post-chemotherapy for inclusion in this publication. The KIYATEC assay successfully predicted responders (i.e. platinum sensitive) and non-responders (i.e. platinum resistant) with an accuracy of 89% (39/44, p<0.0001).

    Investigators also assessed assay accuracy and correlation to outcome among the 35 of 44 (80%) patients who received adjuvant chemotherapy. In this cohort, the KIYATEC assay correctly predicted responders and non-responders with 89% accuracy (31/35, p=0.0004). From date of surgical debulk, progression free survival (PFS) among test subjects predicted to respond to the first line chemotherapy they received was over 20 months v. 9 months for patients predicted not to respond (p=0.01).

    “At present, clinicians have no way of knowing, prior to treatment, which of our newly diagnosed or relapsed ovarian cancer patients will respond or not to approved drug therapies,” said Larry Maxwell, MD, Chairman of Obstetrics and Gynecology and co-director of Inova’s Women’s Health Integrated Research Center (WHIRC), and an author of the study. “To predict a complex future result with very high accuracy is a meaningful achievement, especially given that sometimes these outcomes take months to define. Similar test performance in larger, follow-on studies would establish this as a go-to tool in cancer drug selection that should help improve patient outcomes in ovarian cancer.”

    Based on these promising findings, KIYATEC has opened a prospective, pivotal clinical study, 3D-PREDICT (NCT03561207), in 500 patients to further validate EV3D-enabled clinical assays for newly diagnosed and recurrent ovarian cancer (8-drug panel) and glioblastoma (12-drug panel). The study is currently open to enrollment.

    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.