PARTNERSHIPS

Streamlined CDx® Development

PARTNERSHIPS

Streamlined
CDx® Development

A proven strategy to accelerate drug approvals

Companion Diagnostics represents a critical milestone in precision medicine and plays a pivotal role in the validation of targeted therapies. Traditional CDx development models involve multiple partners adding complexity and increasing risk that could affect drug approvals. Our Streamlined CDx® program has demonstrated value, accelerating the international approvals of new targeted therapies for several pharmaceutical companies.

A proven strategy to accelerate drug approvals

Companion Diagnostics represents a critical milestone in precision medicine and plays a pivotal role in the validation of targeted therapies. Traditional CDx development models involve multiple partners adding complexity and increasing risk that could affect drug approvals. Our Streamlined CDx® program has demonstrated value, accelerating the international approvals of new targeted therapies for several pharmaceutical companies.

Product Development

Product Development

Design Controls

All biomarker assays & software developed under design controls

Bioinformatics Software

Comprehensive LymphoTrack® Dx clonality with bioinformatics software

Identify & Track

Multiple NGS gene panels that identify and track clinically-actionable biomarkers

Custom Development

Development of custom biomarker assays

Complementary MRD Assays

Complementary MRD assays for all biomarkers – potential for surrogate endpoints per agency inputs

Manufacturing

Manufacturing

cGMP Compliant

US FDA/CDRH registered, EN ISO 13485:2016 certified manufacturing facility based in San Diego

CE-marked IVDs & CDx Manufacturing

PMA companion diagnostics (CDx) for US and Japan, inclusion of CDx in ARTG Australia and >50 CE-IVDs (NGS assays include bioinformatics software)

Assay Development

IUO and RUO assays, CE-marked IVDs, and CDx development

Controls & Reagents

DNA / RNA controls, ASRs, GPRs, MRD controls & proficiency panels

LabPMM®

LabPMM®

Clinical Lab Experience

A dozen years of clinical reference lab experience

Internationally Standardized

Internationally standardized CDx and biomarker testing with internationally accredited labs serving the US, Europe, and Asia.

Comprehensive Panels

Comprehensive LymphoTrack® clonality/MRD assays and NGS MyGene™ panels identify clinically-actionable biomarkers

Complementary MRD Assays

Complementary MRD assays for all biomarkers – potential for surrogate future endpoints per agency inputs

Worldwide Enrollment

Testing services have supported hundreds of enrollment sites worldwide

Global Regulatory Expertise

Global Regulatory Expertise

Accredited & Proven

EN ISO 13485:2016 accredited. Experienced staff & proven Quality Management System.

Registered Medical Device Establishment

Registered Medical Device Establishment with the US FDA, KFDA, Saudi Arabia, and the MHLW/PMDA.

Multiple CDx Approvals

Multiple CDx approvals supporting various drugs: by the FDA (US), PMDA/MHLW (Japan), and TGA (Australia). CDx CE-marked IVD in the EU.

CE-marked IVDs

>50 CE-marked IVDs available in the EU and select ROW markets; >60 tests included in the ARTG in Australia.

Marketing Authorization Holder (MAH)

Marketing Authorization Holder (MAH) and national reimbursement for CDx in Japan.

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