Predicine Company Profile

Background

Predicine, Inc. is a molecular insights company dedicated to advancing precision medicine in oncology and infectious diseases. Founded in 2015, the company specializes in developing proprietary cell-free DNA (cfDNA) and cell-free RNA (cfRNA) liquid biopsy technologies. These innovations enable minimally invasive molecular diagnostics for early cancer detection, treatment selection, therapy monitoring, minimal residual disease (MRD) detection, and disease progression assessment. Predicine's mission is to empower the global healthcare ecosystem through innovation, with a vision to transform patient care by providing accessible and accurate genomic profiling solutions.

Key Strategic Focus

Predicine's strategic objectives include:

Development of Comprehensive Genomic Profiling Assays: Creating next-generation sequencing (NGS) assays for blood, urine, and tissue samples to detect a wide range of genomic alterations.

Global Expansion: Establishing a presence in key international markets to support global clinical trials and patient testing.

Companion Diagnostics (CDx) Development: Collaborating with pharmaceutical companies to develop assays that identify patients who may benefit from targeted therapies.

Technological Innovation: Advancing liquid biopsy technologies to improve the sensitivity and specificity of cancer diagnostics.

Financials and Funding

As a privately held company, specific financial details and funding history for Predicine are not publicly disclosed. The company has demonstrated growth through strategic partnerships and product development initiatives.

Pipeline Development

Predicine's key products and developments include:

PredicineCARE™ NGS Kit: A research-use-only NGS kit for genomic profiling across various cancers, utilizing cfDNA from liquid biopsy samples and genomic DNA from formalin-fixed paraffin-embedded (FFPE) tissues. This kit received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) in August 2022.

PredicineCARE™ cfDNA Assay: A CE-marked assay for genomic profiling in blood and urine, targeting 152 genes associated with cancer. It has been utilized in global clinical trials, patient testing, and companion diagnostics development.

PredicineALERT™: A methylation-based MRD detection assay designed to monitor therapy response and detect minimal residual disease.

PredicineBEACON™: A personalized MRD monitoring assay that tracks specific genomic alterations in individual patients.

Technological Platform and Innovation

Predicine's technological innovations include:

Proprietary Liquid Biopsy Technology: Enables the detection of cfDNA and cfRNA from blood and urine samples, facilitating non-invasive cancer diagnostics.

Comprehensive NGS Assays: Capable of detecting single nucleotide variants (SNVs), insertions and deletions (indels), DNA rearrangements (fusions), copy number variations (CNVs), and gene deletions across multiple cancer-associated genes.

Decentralized Testing Solutions: The PredicineCARE™ NGS Kit allows for standardized genomic profiling in decentralized laboratory settings, supporting global clinical trials and patient testing.

Leadership Team

Shidong Jia, MD, PhD: Founder, Chairman, and CEO. Dr. Jia has extensive experience in oncology biomarker strategies and drug-diagnostics co-development, having held senior positions at Genentech, Novartis Institutes for BioMedical Research, and Harvard University.

Pan Du, PhD: Co-founder, President, and Chief Technology Officer. Dr. Du is an expert in next-generation sequencing, bioinformatics, and oncology diagnostics, with previous roles at Roche Diagnostics, Genentech, and Northwestern University.

Leadership Changes

As of the latest available information, there have been no recent significant changes or appointments within Predicine's leadership team.

Competitor Profile

Market Insights and Dynamics

The liquid biopsy market is experiencing significant growth, driven by the increasing demand for non-invasive cancer diagnostics and personalized medicine. Advancements in NGS technologies and the rising prevalence of cancer contribute to the market's expansion.

Competitor Analysis

Key competitors in the liquid biopsy and genomic profiling space include:

Guardant Health: Specializes in blood-based comprehensive genomic profiling for cancer patients.

Foundation Medicine: Offers tissue and liquid biopsy tests for comprehensive genomic profiling.

Natera: Provides cfDNA testing for cancer detection and monitoring.

Caris Life Sciences: Develops molecular profiling assays for cancer diagnostics.

These companies focus on various aspects of liquid biopsy and genomic profiling, contributing to a competitive landscape in precision oncology diagnostics.

Strategic Collaborations and Partnerships

Predicine has established several significant collaborations:

Janssen Pharmaceutica NV: In January 2024, Predicine partnered with Janssen to develop the PredicineCARE™ urine cfDNA NGS assay as a companion diagnostic for localized bladder cancer.

Apollomics, Inc.: In April 2024, Predicine collaborated with Apollomics to develop the PredicineCARE™ blood cfDNA NGS assay for identifying non-small cell lung cancer patients eligible for targeted therapy.

Epic Sciences, Inc.: In October 2020, Predicine entered a strategic partnership with Epic Sciences to offer biopharmaceutical companies access to both Predicine’s ctDNA-based testing and Epic’s circulating tumor cell (CTC)-based testing, enabling comprehensive cancer profiling from a single blood draw.

Operational Insights

Predicine's strategic considerations include:

Global Laboratory Network: Operating CAP-accredited and CLIA-certified laboratories in the United States and China to support global clinical trials and patient testing.

Decentralized Testing Solutions: Offering the PredicineCARE™ NGS Kit to enable standardized genomic profiling in decentralized laboratory settings worldwide.

Focus on Liquid Biopsy Innovation: Advancing cfDNA and cfRNA technologies to improve the sensitivity and specificity of non-invasive cancer diagnostics.

Strategic Opportunities and Future Directions

Predicine's strategic roadmap includes:

Regulatory Approvals: Pursuing FDA approvals for its assays to expand their clinical applications and market reach.

Expansion into Early Cancer Detection: Developing assays for early detection of various cancers to improve patient outcomes.

Enhanced Companion Diagnostics: Strengthening collaborations with pharmaceutical companies to develop companion diagnostics for targeted therapies.