We work with diagnostic companies—especially those developing point-of-care molecular tests—to accelerate product development and regulatory readiness. Whether you’re preparing for FDA submission or refining assay performance, we bring deep scientific and regulatory expertise to support your innovation pipeline.
Why Partner With Us?
End-to-End Support: From feasibility studies to FDA submission.
Tailored Solutions: Customized validation plans and regulatory pathways.
Experienced Team: Expertise in molecular diagnostics, pathology, and regulatory compliance.
Flexible Collaboration Models: Whether you need short-term consulting or long-term partnerships, we adapt to your needs.
We have expertise in ctDNA biomarker assays for DICER1 related tumors and Diffuse Midline Glioma, large sequencing panels for oncogenes and expression analysis.
We like to foster strong partnerships with academic and clinical institutions. We have a significant relationship with Rutgers University for PCR technology.
