Diagnostic Development Services

As a leading preclinical CRO, Alfa Cytology is at the forefront of advancing personalized cancer care through the development of innovative diagnostic solutions. One of our key focus areas is the diagnostics for Poly(ADP-ribose) polymerase (PARP) inhibitors, a promising class of targeted cancer therapies.

Introduction to Diagnostic Development for PARP Inhibitor

Emerging research has highlighted the complex landscape of DNA damage response (DDR) pathways and the multiple mechanisms of homologous recombination defects (HRDs) that can predispose tumor cells to PARP inhibition. These mechanisms include not only germline and somatic mutations in BRCA1/2, but also alterations in other HRR genes, as well as genomic scars or features indicative of HRD phenotypes. Accurate identification and validation of these biomarkers is essential to expand the use of PARP inhibitors. However, the development of reliable diagnostic tools is a major challenge for the oncology community.

Fig. 1 Candidate genomic biomarkers for PARP inhibitors (PARPis) in cancer. (Dong Q., et al. 2021)

Our Services

At Alfa Cytology, our team of experts leverages a multidisciplinary approach to address these challenges. We employ a deep understanding of the DDR pathways, utilize state-of-the-art genomic profiling and functional assays, and collaborate with our client to develop robust biomarker solutions.

IVD Product Development Service

Developing robust, clinically-validated in vitro diagnostic (IVD) assays for the identification of biomarkers associated with PARP inhibitor response.
Leveraging state-of-the-art genomic profiling technologies, including next-generation sequencing, PCR-based, and functional HRD assays.
Comprehensive assay development, optimization, and validation to ensure analytical and clinical performance.
Ensuring alignment with regulatory requirements for IVD product commercialization.

Point-of-Care Test Development Service

Designing user-friendly, rapid point-of-care (POC) diagnostic tests for PARP inhibitor biomarkers.
Optimizing test platforms for ease of use, reduced turnaround time, and suitability for clinical settings.
Ensuring reliable and reproducible results through rigorous analytical and clinical validation.
Facilitating the seamless integration of POC tests into clinical workflows to support timely treatment decisions.

Companion Diagnostics Development Service

Collaborating closely with pharmaceutical partners to co-develop and validate companion diagnostic tests for their PARP inhibitor programs.
Aligning the companion diagnostic with the specific drug indications and regulatory requirements.
Providing end-to-end support, from biomarker identification and assay development to clinical validation and regulatory submission.
Ensuring the optimal utilization of PARP inhibitors through the implementation of reliable, clinically-validated diagnostic solutions.

PARPi Responsive Biomarker Discovery Service

PARPi Resistant Biomarker Discovery Service

Imaging Service of PARP

PARP Activity Assay Service

Our Services Workflow

By leveraging this comprehensive suite of services, Alfa Cytology is committed to empowering precision oncology through the development of innovative diagnostic solutions for PARP inhibitor therapy. Contact us to learn more about how our comprehensive services can support your diagnostic development for PARP.

Reference

Dong Q., Liu M., and et al. Revealing biomarkers associated with PARP inhibitors based on genetic interactions in cancer genome. Comput Struct Biotechnol J. 2021, 19: 4435-4446.

For research use only. Not intended for any clinical use.