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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 ⟶
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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 ⟶
- Companion Diagnostic (CDx) Tests
  CDx – USA
  CDx – Germany
  CDx – Japan
- NGS Cancer Panels
  MyAML
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DISEASES
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  Lymphoma
  Lymphoma is a cancer that starts in cells that are part of the body’s immune system. Knowing which type of lymphoma you have is important because it affects your treatment options and your outlook (prognosis).
  
  LEARN MORE ⟶
- Myeloid
  Myelodysplastic Syndromes (MDS)
  Acute Myeloid Leukemia (AML)
  Myeloproliferative Neoplasms (MPNs)
  
  Myeloma
  Multiple myeloma is a cancer of plasma cells. Normal plasma cells are found in the bone marrow and are an important part of the immune system.
  
  LEARN MORE ⟶
- 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
  
  November 17th, 2020
  Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing
  VIEW PUBLICATION ⟶
- Latest Publications
  
  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
  VIEW PUBLICATION ⟶
  
  November 17th, 2020
  Routine Evaluation of Minimal Residual Disease in Myeloma Using Next-Generation Sequencing Clonality Testing
  VIEW PUBLICATION ⟶
  
  VIEW ALL PUBLICATIONS ⟶
COMPANY
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  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 ⟶
- Clinical Lab Locations
  
  LabPMM, LLC (USA)
  
  San Diego, CA, US
  
  CONTACT US ⟶
  
  LabPMM, GmbH (Germany)
  
  Munich, Germany
  
  CONTACT US ⟶
  
  LabPMM, GK (Japan)
  
  Kawasaki, Japan
  
  CONTACT US ⟶
  
  Invivoscribe Diagnostic Technologies,(Shanghai) Co.,Ltd.
  
  Shanghai, China
  
  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 ⟶

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- 1 x 50 µL
- 10 x 100 uL
- 1000 µL
- 12 indices per FR region – 5 reactions each
- 12-index Kit (60 reactions)
- 24 indices per FR region – 5 reactions each
- 24-index Kit (120 reactions)
- 6 x 100 uL
- 6 x 50 uL
- 6 x 50 µL
- 7 x 100 uL
- 8 indices per FR region – 5 reactions each
- 8-index Kit (40 reactions)
- MegaKit (300 Reactions)
- MegaKit (300/330 reactions)
- MegaKit (330 reactions)
- Regular Kit (30 Reactions)
- Regular Kit (30/33 reactions)
- Regular Kit (33 reactions)
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Quality Management System: ISO 13485

Marketing2018-12-02T23:06:34+00:00December 2nd, 2018|Categories: Certificates|

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INVIVOSCRIBE

Invivoscribe, Inc. (USA)

San Diego, CA, US

Invivoscribe Therapeutics, Inc. (USA)

San Diego, CA, US

Invivoscribe, SARL (France)

La Ciotat, France

Invivoscribe Diagnostic Technologies, (Shanghai) Co., Ltd.

Shanghai, China

CLINICAL LAB LOCATIONS

LabPMM, LLC (USA)

San Diego, CA, US

LabPMM, GmbH (Germany)

Munich, Germany

LabPMM, GK (Japan)

Kawasaki, Japan

Invivoscribe Diagnostic Technologies, (Shanghai) Co., Ltd.

Shanghai, China

PRIVACY/TERMS & CONDITIONS

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End User License Agreement

THIS END USER LICENSE AGREEMENT MUST BE ACCEPTED BY AN AUTHORIZED REPRESENTATIVE OF THE END USER OF THIS PRODUCT PRIOR TO USING THE LYMPHOTRACK® DX SOFTWARE(the “Software”). BY USING THE LYMPHOTRACK® DX SOFTWARE, YOU ASSERT THAT YOU ARE AN AUTHORIZED REPRESENTATIVE OF THE END USER WITH AUTHORITY TO ENTER INTO THIS AGREEMENT. PLEASE READ THIS AGREEMENT CAREFULLY. BY USING THE SOFTWARE, YOU ARE AGREEING TO BE BOUND BY THE TERMS OF THIS AGREEMENT. IF YOU DO NOT AGREE TO THE TERMS OF THIS AGREEMENT, PLEASE DISCONTINUE USAGE. IF YOU DO AGREE TO THE TERMS OF THIS AGREEMENT ON BEHALF OF YOURSELF AND/OR THE ENTITY YOU REPRESENT YOU MAY CONTINUE USAGE.

This End User License Agreement (“EULA”) is made and entered into by and between INVIVOSCRIBE, INC, a California corporation. (“Licensor”) and you, as the user of the Software (either you as an individual or a legal entity), the “Licensee” for the licensing and usage of the Licensor’s Software. Licensee acknowledges and agrees that Licensee’s right to use the Software in any manner shall be controlled by this EULA and that such use shall be strictly in accordance with the terms and conditions of this EULA.

1. GRANT OF LICENSE. Licensor grants to Licensee a non-exclusive, non-transferable, limited license, without the right to sublicense, to use the Software and any accompanying written materials and any documents or other content embodying information contained within the Software (collectively, the “Product”) solely for Licensee’s own internal use. Except as agreed in a document signed by Licensor, the Software license granted in the preceding sentence is limited to use with Licensor’s LymphoTrack® Dx Assays purchased from Licensor or from an authorized distributor of Licensor. Licensor reserves all rights not expressly granted to Licensee or to Licensee. The limited license granted by this EULA and Licensee’s payment of the license fee give Licensee the right to use the Product only in accordance with the terms of this EULA. This license is not a sale of the original software or any copy thereof.

2. CONFIDENTIALITY. Licensee agrees that the Product is owned by Licensor and is based on and includes the intellectual property of Licensor, including but not limited to one or more proprietary trade secrets, copyrights, patent applications, and/or granted patents (“Intellectual Property”) of Licensor. Licensee’s possession and use of the Product shall be strictly in accordance with this EULA, and receipt or possession does not convey any rights to divulge, reproduce, or allow others to use the Product outside the terms of this EULA without specific written authorization of Licensor. Licensee agrees not to disclose, publish, translate, release, or distribute copies of the Product or any portion thereof to others outside the terms of this EULA. Licensee may not modify, adapt, translate, reverse engineer, decompile, disassemble, or create derivative works based on the Product or any portion thereof, including any documents or other content produced using the software.

3. OWNERSHIP OF PRODUCT. Title to, ownership of, and all rights and interests in the Product, all copies thereof, and “Intellectual Property” relating thereto, remains at all times vested in Licensor, and this EULA does not grant any ownership rights to Licensee.

4. COPY RESTRICTIONS. The Product is copyrighted. Unauthorized copying or modification of the Product, including but not limited to the Software that has been modified, merged, or included with other software, is expressly forbidden. Licensee may be held legally responsible for any copyright infringement that is caused or incurred by Licensee’s failure to abide by the terms of this EULA.

5. TRANSFER RESTRICTIONS. This Product is licensed to Licensee, and may not be transferred to anyone without the prior written consent of Licensor. In no event may Licensee transfer, assign, rent, lease, sell, or otherwise dispose of the Product, or any portion thereof, on a temporary basis, except as expressly provided herein.

6. TERMINATION. This EULA will be terminated automatically without notice if Licensee fails to comply with any of its provisions.

7. LIMITED WARRANTY. THE PRODUCT, INCLUDING SOFTWARE AND ACCOMPANYING WRITTEN MATERIALS, INCLUDING INSTRUCTIONS FOR USE, ARE PROVIDED “AS IS,” WITHOUT WARRANTY OF ANY KIND, AND LICENSOR DISCLAIMS ALL OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, OR STATUTORY, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, TITLE, NON-INFRINGEMENT AND ANY WARRANTIES ARISING FROM COURSE OF DEALING OR COURSE OF PERFORMANCE REGARDING OR RELATING TO THE SOFTWARE, THE DOCUMENTATION OR ANY MATERIALS FURNISHED OR PROVIDED TO YOU UNDER THIS EULA. LICENSOR DOES NOT WARRANT THAT THE SOFTWARE WILL OPERATE UNINTERRUPTED OR THAT IT WILL BE FREE FROM DEFECTS OR THAT THE SOFTWARE WILL MEET (OR IS DESIGNED TO MEET) YOUR BUSINESS REQUIREMENTS.

8. LIMITED LIABILITY. TO THE MAXIMUM EXTENT PERMITTED BY LAW, IN NO EVENT SHALL LICENSOR BE LIABLE FOR ANY LOST PROFITS OR BUSINESS OPPORTUNITIES, LOSS OF USE, LOSS OFREVENUE, LOSS OF GOODWILL, BUSINESS INTERRUPTION, LOSS OF DATA, OR ANY OTHER INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES UNDER ANY THEORY OF LIABILITY, WHETHER BASED IN CONTRACT, TORT, NEGLIGENCE, PRODUCT LIABILITY, OR OTHERWISE. BECAUSE SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE PRECEDING LIMITATION MAY NOT APPLY TO LICENSEE. LICENSOR’S LIABILITY UNDER THIS EULA WILL NOT, IN ANY EVENT, REGARDLESS OF WHETHER THE CLAIM IS BASED IN CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE, EXCEED THE LICENSE FEES LICENSEE PAID FOR THE SOFTWARE, IF ANY. THE FOREGOING LIMITATIONS SHALL APPLY REGARDLESS OF WHETHER LICENSOR HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES AND REGARDLESS OF WHETHER ANY REMEDY FAILS OF ITS ESSENTIAL PURPOSE.

9. EXCLUSIVE REMEDY. Licensee’s exclusive remedy and Licensor’s entire liability for breach by Licensor of this EULA shall be limited, at Licensor’s sole and exclusive discretion, to: (i) replacement of any defective Software or related Documentation; or (ii) refund of the consideration paid to Licensor for the Software

10. GOVERNING LAW. This EULA shall be governed by the laws of the State of California, irrespective of its conflicts of laws principles, and Licensee consents to jurisdiction by the state and federal courts sitting in the State of California.

11. COMPLETE AGREEMENT. This EULA is the entire agreement between Licensor and Licensee with respect to the specific terms set forth herein concerning license and warranties of the Product and any other included term or obligation. This EULA replaces all prior understandings and agreements, whether written or oral. This EULA may not be modified unless Licensor and Licensee both agree to such modification in writing.

12. SEVERABILITY. If for any reason a court of competent jurisdiction finds any provision or part of any provision of this EULA unenforceable, that part or provision shall be enforced to the maximum extent permitted by law so as to affect the intent of the parties, and the remainder of the EULA shall continue in full force and effect.

©2021 Invivoscribe, Inc. All rights reserved. The trademarks mentioned herein are the property of Invivoscribe, Inc. and/or its affiliates, or (as to the trademarks of others used herein) their respective owners.

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Invivoscribe Announces Key Submission in the EU ⟶

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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.

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

Quality Management System: ISO 13485

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