Partnerships2019-07-10T23:44:04+00:00
PARTNERSHIPS

Streamlined CDx

PARTNERSHIPS

Streamlined
CDx

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 which could affect drug approvals. Our Streamlined CDx™ program has demonstrated value, accelerating the international approvals of multiple new targeted therapies for multiple 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 which could affect drug approvals. Our Streamlined CDx™ program has demonstrated value, accelerating the international approvals of multiple new targeted therapies for multiple 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

Custom biomarker assay development

Complementary MRD Assays

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

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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 & RUO assays, CE-marked IVDs, & CDx

Controls & Reagents

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

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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

Partnership Inquiries

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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.

Partnership Inquiries

Please fill out the form below, and we will respond within 24 hours during a normal business week.

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