Press Releases Archives - Page 2 of 3

Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit.

wmm2019-07-04T21:14:04+00:00August 1st, 2017|Categories: Press Releases|Tags: CDx, CE-Marked, CE-marked IVD Assay, FLT3, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

FDA approves new combination treatment for acute myeloid leukemia

wmm2019-07-04T21:14:53+00:00April 28th, 2017|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, Combination Treatment, FDA, FDA Approval|

⟵ PRESS RELEASES PRESS RELEASE SILVER SPRING, [...]

Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML

wmm2019-07-04T21:16:10+00:00April 28th, 2017|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, CDx, Companion Diagnostics, FDA, FDA Approval, LeukoStrat, LeukoStrat® CDx FLT3 Mutation Assay, Rydapt®|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

Invivoscribe Expands Business into Solid Tumors with Assays and Services to Identify and Monitor CAR-T and TCR Immuno-Therapies

wmm2019-07-04T21:17:23+00:00March 28th, 2017|Categories: Press Releases|Tags: Assays, CAR-T, CAR-T and TCR Immuno-Therapies, Immuno-Therapies, Services, Solid Tumors, TCR|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

Invivoscribe Expands Ion PGM NGS Platform Menu: Releases Additional CE-IVD Clonality Kits with Bioinformatics Software and RUO Kits with MRD Software

wmm2019-07-04T21:19:54+00:00February 28th, 2017|Categories: Press Releases|Tags: Bioinformatics, Bioinformatics Software, CE-IVD, CE-IVD Clonality Kits, Clonality, Ion PGM, Ion PGM NGS Platform Menu, Minimal Residual Disease, MRD, MRD Software, Next-Generation Sequencing, NGS, Research Use Only, RUO|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

Invivoscribe Announces Long-Term Collaboration Agreement with Illumina and Plans Release of NGS-based IVD Assay Kits

wmm2019-07-04T21:21:15+00:00February 14th, 2017|Categories: Press Releases|Tags: Illumina, IVD, IVD Assay Kits, Next-Generation Sequencing, NGS|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

Invivoscribe Expands Long-Term Collaboration Agreement to Release FLT3 Mutation and Clonality Assay Kits

wmm2019-07-04T21:25:15+00:00January 31st, 2017|Categories: Press Releases|Tags: Clonality, Clonality Assay Kits, FLT3, FLT3 Mutations, Internal Tandem Duplication, ITD, Next-Generation Sequencing, NGS, NGS Based Assays, TKD, Tyrosine Kinase Domain|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis

wmm2019-07-04T21:27:37+00:00November 14th, 2016|Categories: Press Releases|Tags: Acute Myeloid Leukemia, Advanced Systemic Mastocytosis, AML, FDA, FDA Priority Review, FLT3, FLT3-mutated AML, Midostaurin, Novartis, Novartis drug PKC412|

⟵ PRESS RELEASES PRESS RELEASE Basel - [...]

Ion Torrent Developers Alliance Program Designed to Speed Targeted NGS Assay Development

wmm2019-07-04T21:29:12+00:00May 31st, 2016|Categories: Press Releases|Tags: Developers Alliance Program, Ion Torrent, Next-Generation Sequencing, NGS, Targeted NGS Assay|

⟵ PRESS RELEASES PRESS RELEASE CARLSBAD, CA [...]

German Supreme Court Upholds and Strengthens Invivoscribe FLT3 Patent Position

wmm2019-07-04T21:29:37+00:00March 28th, 2016|Categories: Press Releases|Tags: FLT3, FLT3 Patent, Germany|

⟵ PRESS RELEASES PRESS RELEASE SAN DIEGO, [...]

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Invivoscribe provides a full range of standardized CE-marked in vitro diagnostic cGMP products for hematology-oncology, as well as RUO assays, analyte specific reagents (ASRs), and DNA & RNA controls.

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.

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.

March 21st, 2019
Establishment of Immunoglobulin Heavy (IGH) Chain Clonality Testing by Next-Generation Sequencing for Routine Characterization of B-Cell and Plasma Cell Neoplasms

August 25th, 2018
A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations

August 22nd, 2018
Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL

Invivoscribe® Releases LeukoStrat® CDx FLT3 Mutation Assay as CE-marked IVD Assay Kit.

FDA approves new combination treatment for acute myeloid leukemia

Invivoscribe® Receives FDA Approval for the LeukoStrat® CDx FLT3 Mutation Assay Companion Diagnostic Test for the Selection of Patients for Rydapt® and is the First Companion Diagnostic for AML

Invivoscribe Expands Business into Solid Tumors with Assays and Services to Identify and Monitor CAR-T and TCR Immuno-Therapies

Invivoscribe Expands Ion PGM NGS Platform Menu: Releases Additional CE-IVD Clonality Kits with Bioinformatics Software and RUO Kits with MRD Software

Invivoscribe Announces Long-Term Collaboration Agreement with Illumina and Plans Release of NGS-based IVD Assay Kits

Invivoscribe Expands Long-Term Collaboration Agreement to Release FLT3 Mutation and Clonality Assay Kits

Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis

Ion Torrent Developers Alliance Program Designed to Speed Targeted NGS Assay Development

German Supreme Court Upholds and Strengthens Invivoscribe FLT3 Patent Position

Invivoscribe provides a full range of standardized CE-marked in vitro diagnostic cGMP products for hematology-oncology, as well as RUO assays, analyte specific reagents (ASRs), and DNA & RNA controls.

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.

Browse our comprehensive menu of product & testing services.

A proven strategy to acceleratedrug 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.

March 21st, 2019 Establishment of Immunoglobulin Heavy (IGH) Chain Clonality Testing by Next-Generation Sequencing for Routine Characterization of B-Cell and Plasma Cell Neoplasms

August 25th, 2018 A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations

August 22nd, 2018 Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL

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.

A proven strategy to accelerate
drug approvals

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

March 21st, 2019
Establishment of Immunoglobulin Heavy (IGH) Chain Clonality Testing by Next-Generation Sequencing for Routine Characterization of B-Cell and Plasma Cell Neoplasms

August 25th, 2018
A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations

August 22nd, 2018
Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL