FDA Archives - Invivoscribe

PRODUCTS
- Products Overview
  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.
  EXPLORE PRODUCTS ⟶
- Next-Generation Sequencing
  CE-IVD
  Illumina®
  Thermo Fisher®
  RUO
  Illumina®
  Thermo Fisher®
  MRD Clonality
- ABI Fluorescence Detection
  CE-IVD
  Clonality
  FLT3
  RUO
  Clonality
  FLT3
  Translocations
  Companion Diagnostics
- Gel Detection
  CE-IVD
  Clonality
  FLT3
  Translocations
  RUO
  Clonality
  FLT3
  Translocations
- Controls
  Master Mix Controls
  DNA Controls
  RNA Controls
  MRD Controls
- Reagents
  ASRs
  Enzymes
  Hi-Di Formamide
- Companion Diagnostics (CDx)
- NEW! 2020 Product Catalog
CLINICAL LAB SERVICES
- Clinical Lab Services Overview
  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.
  EXPLORE SERVICES ⟶
- CORONAVIRUS
  COVID-19 TESTING
  
  Performed with real-time reverse transcription polymerase chain reaction (RT-PCR) to detect nucleic acid from SARS-CoV-2.
  
  LEARN MORE ⟶
- NGS Cancer Panels
  MyMRD
  MyAML
  MyHEME
- MRD NGS Tests
  Clonality
  FLT3 ITD
  NPM1
- Targeted Genes
  FLT3
  NPM1
- Clonality NGS Tests
  SHM
  IGH
  IGK
  TRG
  TRB
DISEASES
- Lymphoid
  Mature B-cell
  Mature T-cell
- Myeloid
  Myelodysplastic Syndromes (MDS)
  Acute Myeloid Leukemia (AML)
  Myeloproliferative Neoplasms (MPNs)
- Hematological Testing Menu
  Browse our comprehensive menu of product & testing services.
  EXPLORE MENU ⟶
PARTNERSHIPS
- Partnerships Overview
  A proven strategy to accelerate
  drug approvals
  EXPLORE PARTNERSHIPS ⟶
- Product Development
  Design Controls, Bioinformatics Software, Identify & Track, Custom Development, and Complementary MRD Assays
  EXPLORE ⟶
- Manufacturing
  cGMP Compliant, CE-marked IVDs & CDx Manufacturing, Assay Development, and Controls & Reagents
  EXPLORE ⟶
- LabPMM®
  Clinical Lab Experience, Internationally Standardized, Comprehensive Panels, Complementary MRD Assays, and Worldwide Enrollment
  EXPLORE ⟶
- Global Regulatory Expertise
  Accredited & Proven, Registered Medical Device Establishment, Multiple CDx Approvals, CE-marked IVDs, and Marketing Authorization Holder (MAH)
  EXPLORE ⟶
SCIENCE
- Science Overview
  We take pride in expanding the science that bridges personalized medicine with quality healthcare.
  EXPLORE OUR SCIENCE ⟶
- Personalized Medicine
  Personalized Molecular Medicine^® is use of genomics and patient specific information to identify optimal treatment for each patient.
  EXPLORE PERSONALIZED MEDICINE ⟶
PUBLICATIONS
- Featured Publication
  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
  VIEW PUBLICATION ⟶
- Latest Publications
  August 25th, 2018
  A next-generation sequencing–based assay for minimal residual disease assessment in AML patients with FLT3-ITD mutations
  VIEW PUBLICATION ⟶
  August 22nd, 2018
  Simple deep sequencing-based post-remission MRD surveillance predicts clinical relapse in B-ALL
  VIEW PUBLICATION ⟶
  VIEW ALL PUBLICATIONS ⟶
COMPANY
- Company
  About Us
  Leadership Team
  Board of Directors
  Newsroom
  Global Distributors
  Licensure and Certifications
  Search Career Openings
- Invivoscribe Locations
  
  Invivoscribe, Inc. (USA)
  San Diego, CA, US
  CONTACT US ⟶
  
  Invivoscribe Therapeutics, Inc. (USA)
  San Diego, CA, US
  CONTACT US ⟶
  
  Invivoscribe, SARL (France)
  La Ciotat, France
  CONTACT US ⟶
  
  Invivoscribe Diagnostic Technologies,(Shanghai) Co.,Ltd.
  Shanghai, China
  CONTACT US ⟶
- LabPMM Locations
  
  LabPMM, LLC (USA)
  San Diego, CA, US
  CONTACT US ⟶
  
  LabPMM, GmbH (Germany)
  Martinsried, Germany
  CONTACT US ⟶
  
  LabPMM, GK (Japan)
  Kanagawa 210-0821, Japan
  CONTACT US ⟶
- Support
  
  Invivoscribe, Inc. (USA)
  CONTACT US ⟶
  
  Invivoscribe, SARL (France)
  CONTACT US ⟶
  
  Invivoscribe Diagnostic Technologies,(Shanghai) Co.,Ltd.
  CONTACT US ⟶
  
  LabPMM, LLC (USA)
  CONTACT US ⟶
  
  LabPMM, GmbH (Germany)
  CONTACT US ⟶
  
  LabPMM, GK (Japan)
  CONTACT US ⟶
Search
- Search Articles & Publications
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- Search Product & Service Catalog
  CATALOG SEARCH ⟶

Invivoscribe To Present At Biotech Showcase™ 2019 In San Francisco

wmm2019-07-04T21:02:41+00:00January 3rd, 2019|Categories: Press Releases|Tags: CDx, Companion Diagnostics, Dr. Jeffrey E. Miller Ph.D., EMA, FDA, PMDA, Streamlined CDx|

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

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, [...]

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 - [...]

Novartis drug PKC412 (midostaurin) receives Breakthrough Therapy designation from the FDA for newly-diagnosed FLT3-mutated acute myeloid leukemia (AML)

wmm2019-07-04T21:30:56+00:00February 18th, 2016|Categories: Press Releases|Tags: Acute Myeloid Leukemia, AML, FDA, FLT3, FLT3-mutated AML, Midostaurin, Novartis, Novartis drug PKC412|

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

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.

CORONAVIRUS COVID-19 TESTING Performed with real-time reverse transcription polymerase chain reaction (RT-PCR) to detect nucleic acid from SARS-CoV-2.

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

Invivoscribe To Present At Biotech Showcase™ 2019 In San Francisco

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

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

Novartis drug PKC412 (midostaurin) receives Breakthrough Therapy designation from the FDA for newly-diagnosed FLT3-mutated acute myeloid leukemia (AML)

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.

CORONAVIRUS
COVID-19 TESTING

Performed with real-time reverse transcription polymerase chain reaction (RT-PCR) to detect nucleic acid from SARS-CoV-2.

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