About Our Clinical Testing Services

A direct approach to pre-treatment, patient-specific drug response prediction

The promise of personalized medicine (i.e., right patient, right drug, right time) is only truly fulfilled when a cancer patient responds to a test-recommended drug.

We applaud the emergence of molecular diagnostic tests that describe an individual patient’s cancer and corresponding eligibility for specific therapies.  However, many of these tests infer potential benefit from therapy based on population-based data and/or 3rd party drug makers’ pivotal Phase III studies.

Real-world clinical evidence demonstrates that being eligible for a drug and responding clinically to that drug are not one in the same.  For example, among patients who test positive for PD-L1, only about 30% of them experience a response to PD-1/L1 inhibitors. (see reference below)

At KIYATEC, we believe that cancer patients, clinicians and payers deserve better.

We have developed, have published on, and are further validating a direct and objective approach to clinical drug response prediction leveraging our decade’s accumulated  experience serving leading biopharmaceutical companies who have sought our 3D cell culture expertise to unlock response dynamics for their preclinical oncology drug candidates.  We conduct our clinical testing services inside our CLIA-certified clinical laboratory, co-located inside a cancer institute.

clinicalpathway

Our technology platform, known scientifically as ex vivo 3D cell culture, offers accurate, high-throughput and timely drug response prediction for clinical use.

  1. We utilize a patient’s live cancer cells harvested from an already-scheduled, standard of care biopsy or surgical resection.
  2. Using those live cells, we create and replicate patient-specific, living 3D tumor spheroids outside the body.
  3. We “treat” those 3D tumor spheroids with drugs commonly administered in clinical practice for a given cancer.
  4. We objectively assess cellular response (i.e., cell viability, cell death) to determine drug-specific response or non-response.

Reference: Estimation of the Percentage of US Patients With Cancer Who Are Eligible for and Respond to Checkpoint Inhibitor Immunotherapy Drugs, Alyson Haslam, PhD, Vinay Prasad, MD, MPH, JAMA Netw Open. 2019 May; 2(5): e192535.

Clinical Testing Focus & Evidence Development

We are prioritizing cancers with high clinical unmet need.

  • Chronic, prone to recurrence, in which disease control is the primary clinical objective
  • Sub-optimal response rates to first line and follow-on cancer therapies
  • Absence of, or low utility of, prognostic and/or predictive biomarkers and panels to inform and/or guide drug therapy selection

Based on promising published evidence from our prospective pilot study (see below), we are currently prospectively validating two clinical assays that meet this criteria:

  • Epithelial ovarian cancer, newly diagnosed and recurrent
  • High-grade glioma, newly diagnosed and recurrent

Because our clinical assays use live cancer cells, our outcomes data is 100% prospective.  Our validation efforts are designed to meet the following objectives:

  • Accurate prediction of true responders and non-responders to cancer drugs
  • Correlation between test-predicted response and clinical outcome (i.e., progression-free survival, treatment-free interval)

Pilot Study in Ovarian Cancer Provides Compelling Proof of Concept

We conducted a prospective, multi-center pilot study among 44 newly diagnosed ovarian cancer patients to assess the performance of a pre-treatment, patient-specific drug response profile using our ex vivo 3D cell culture platform.  The study, entitled “Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer,” was published in Scientific Reports (Nature Research) in August 2019.

pilotstudydata

Reference: Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer, Shuford S, Wilhelm C, Rayner M, Elrod A, Millard M, Mattingly C, Lotstein A, Smith AM, Guo QJ, O’Donnell L, Elder J, Puls L, Weroha SJ, Hou X, Zanfagnin V, Nick A, Stany MP, Maxwell GL, Conrads T, Sood AK, Orr D, Holmes LM, Gevaert M, Crosswell HE, DesRochers TM, Sci Rep. 2019 Aug 1;9(1):11153. doi: 10.1038/s41598-019-47578-7.

Prospective Validation of Clinical Tests for Ovarian Cancer and High-Grade Glioma

Our pivotal clinical validation study, “3D Prediction of Patient-Specific Response Using Ex Vivo Interrogation of Live Cells from Tumors” (NCT03561207) is open for new patient enrollment and site expansion.

We thank the following institutions who are currently enrolling patients in the 3D-PREDICT Study:

Capital Institute for Neurosciences
Inova Health System
OHSU Knight Cancer Institute
Prisma Health
Roswell Park Comprehensive Cancer Center
UAMS Winthrop P. Rockefeller Cancer Institute
UCSF Helen Diller Family Comprehensive Cancer Center
VA Portland Health Care System

For study information, contact Cecile Rose Vibat, PhD
Email:  cecilerose.vibat@kiyatec.com
Tel:  864-502-2013

Key Citations

Predictive Platform

  • Redefining Personalized Medicine by Drug Response Profiling of Patient-Derived Spheroids
  • Prospective Clinical Validation of Ex Vivo, Patient-Specific Response Prediction to First-Line Chemotherapy

Ovarian Cancer

  • Prospective Validation of an Ex Vivo, Patient-Derived 3D Spheroid Model for Response Predictions in Newly Diagnosed Ovarian Cancer

High-Grade Glioma

  • Prospective Validation of an Ex Vivo 3D Assay for Prediction of Temozolomide Response in Glioblastoma
  • Development of an in Vitro 3D Glioblastoma Model System for Patient-Specific Drug Response Profiling
  • A Complex 3D Model of Glioblastoma for Patient-Specific Drug Response Profiling

Contact Us for Access

Contact Us

We leverage our 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.

Drug Development Services:  We work with leading biopharmaceutical companies to unlock response dynamics (ex vivo efficacy) for their investigational cancer drug candidates in preclinical testing and subsequent clinical trials.

Clinical Testing Services (CLIA-certified laboratory):  In 2019 we published of our assay’s analytical validation and clinical evidence of its predictive performance.  Currently we are further validating drug response-predictive clinical assays as well as undertaking investigator-initiated studies in ovarian cancer, high-grade glioma, breast cancer and rare tumors.

KIYATEC
900-B West Faris Road
Greenville, SC  29605  USA
Tel:  864-502-2013
Email us:  customer.service@kiyatec.com
http://kiyatec.com/
https://www.linkedin.com/company/kiyatec-inc-/
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CLIA certification:  42D2130169