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

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

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

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

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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Partnership Inquiries

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

PARTNERSHIPS

Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML for Treatment with VANFLYTA

Invivoscribe Marketing2023-07-20T17:27:41-07:00July 21st, 2023|2023 Press Releases, Press Releases|

Invivoscribe Partners with Complete Genomics to Develop and Commercialize Biomarker Tests for Oncology and Cancer Research

Invivoscribe Marketing2023-06-05T12:37:16-07:00June 2nd, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces Updated Reimbursement for the LeukoStrat CDx FLT3 Mutation Assay to Select Newly Diagnosed FLT3-ITD Positive AML Patients Eligible for VANFLYTA in Japan

Invivoscribe Marketing2023-05-25T17:09:22-07:00May 25th, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces IVDR Approval of the LeukoStrat CDx FLT3 Mutation Assay

Invivoscribe Marketing2023-05-11T03:12:47-07:00May 11th, 2023|2023 Press Releases, Press Releases|

Clonal Characterization and Somatic Hypermutation Assessment by Next-Generation Sequencing in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

wmm2023-04-10T20:22:16-07:00March 23rd, 2023|2023 Publications, Featured Publications, Publications|

ALL RELATED ARTICLES ⟶

PARTNERSHIPS

Invivoscribe Announces FDA Approval of the LeukoStrat CDx FLT3 Mutation Assay to Select Patients with FLT3-ITD Positive AML for Treatment with VANFLYTA

Invivoscribe Marketing2023-07-20T17:27:41-07:00July 21st, 2023|2023 Press Releases, Press Releases|

Invivoscribe Partners with Complete Genomics to Develop and Commercialize Biomarker Tests for Oncology and Cancer Research

Invivoscribe Marketing2023-06-05T12:37:16-07:00June 2nd, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces Updated Reimbursement for the LeukoStrat CDx FLT3 Mutation Assay to Select Newly Diagnosed FLT3-ITD Positive AML Patients Eligible for VANFLYTA in Japan

Invivoscribe Marketing2023-05-25T17:09:22-07:00May 25th, 2023|2023 Press Releases, Press Releases|

Invivoscribe Announces IVDR Approval of the LeukoStrat CDx FLT3 Mutation Assay

Invivoscribe Marketing2023-05-11T03:12:47-07:00May 11th, 2023|2023 Press Releases, Press Releases|

Clonal Characterization and Somatic Hypermutation Assessment by Next-Generation Sequencing in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma

wmm2023-04-10T20:22:16-07:00March 23rd, 2023|2023 Publications, Featured Publications, Publications|

ALL RELATED ARTICLES ⟶

The Laboratory for Personalized Molecular Medicine® (LabPMM®) at Invivoscribe offer internationally standardized testing of novel and proprietary biomarkers that are critically important for patient care.

Lymphoma

Myeloma

Browse our comprehensive menu of product & testing services.

A proven strategy to accelerate drug approvals

Design Controls, Bioinformatics Software, Identify & Track, Custom Development, and Complementary MRD Assays

cGMP Compliant, CE-marked IVDs & CDx Manufacturing, Assay Development, and Controls & Reagents

Clinical Lab Experience, Internationally Standardized, Comprehensive Panels, Complementary MRD Assays, and Worldwide Enrollment

Accredited & Proven, Registered Medical Device Establishment, Multiple CDx Approvals, CE-marked IVDs, and Marketing Authorization Holder (MAH)

We take pride in expanding the science that bridges personalized medicine with quality healthcare.

Personalized Molecular Medicine® is use of genomics and patient specific information to identify optimal treatment for each patient.

November 17th, 2020 Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing

April 20th, 2021 Validation of a Next-Generation Sequencing-based T-Cell Receptor Gamma Gene Rearrangement Diagnostic Assay: Transitioning from Capillary Electrophoresis to Next-Generation Sequencing

November 17th, 2020 Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing

Lymphoma

Myeloma

Browse our comprehensive menu of product & testing services.

PARTNERSHIPS

Streamlined CDx

PARTNERSHIPS

Streamlined CDx

A proven strategy to accelerate drug approvals

A proven strategy to accelerate drug approvals

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

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

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.

Partnership Inquiries

PARTNERSHIPS

Related Articles

PARTNERSHIPS

Related Articles

Title

The Laboratory for Personalized Molecular Medicine^® (LabPMM^®) at Invivoscribe offer internationally standardized testing of novel and proprietary biomarkers that are critically important for patient care.

Personalized Molecular Medicine^® is use of genomics and patient specific information to identify optimal treatment for each patient.

November 17th, 2020
Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing

April 20th, 2021
Validation of a Next-Generation Sequencing-based T-Cell Receptor Gamma Gene Rearrangement Diagnostic Assay: Transitioning from Capillary Electrophoresis to Next-Generation Sequencing

November 17th, 2020
Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing

Streamlined
CDx

Comprehensive LymphoTrack^® Dx clonality with bioinformatics software

LabPMM^{^®}

LabPMM^{^®}

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