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 ⟶
  SEARCH PRODUCT DOCUMENTS & IFUs ⟶
- Next-Generation Sequencing
  CE-IVD
  Illumina®
  Thermo Fisher®
  RUO
  Illumina®
  Thermo Fisher®
  MRD Clonality
- Companion Diagnostics (CDx)
  CE-IVD
  IVD (USA)
- ABI Fluorescence Detection
  CE-IVD
  Clonality
  FLT3
  RUO
  Clonality
  FLT3
  Translocations
- 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
- 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
  August 13th, 2020
  Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia
  VIEW PUBLICATION ⟶
- Latest Publications
  August 13th, 2020
  Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia
  VIEW PUBLICATION ⟶
  October 1st, 2019
  Stability and uniqueness of clonal immunoglobulin CDR3 sequences for MRD tracking in multiple myeloma
  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
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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.

August 13th, 2020 Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

August 13th, 2020 Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

October 1st, 2019 Stability and uniqueness of clonal immunoglobulin CDR3 sequences for MRD tracking in multiple myeloma

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.

August 13th, 2020
Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

August 13th, 2020
Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

October 1st, 2019
Stability and uniqueness of clonal immunoglobulin CDR3 sequences for MRD tracking in multiple myeloma