OVER 28 YEARS EXPERIENCE
Improving Lives with Precision Diagnostics®
OVER 28 YEARS EXPERIENCE
Improving Lives with
Precision Diagnostics®
INDUSTRY PIONEERS
We are the foremost experts in providing molecular products and services for oncology testing.
Invivoscribe offers a full range of oncology testing products and services (B- and T-cell clonality, NGS gene panels, MRD assays, and comprehensive bioinformatics software), all developed under ISO 13485 design control and manufactured in our cGMP facility.
MESSAGE FROM THE CEO
Dear Colleagues:
As we begin 2023, I want to take a moment to express gratitude to our customers for your hard work and dedication and, further, your feedback on our products that you have provided over the past year. Our mission is to improve patient lives by providing standardized, innovative precision diagnostics. Improving the quality of healthcare worldwide is not easy, and it cannot be achieved alone, so – Thank you!
As in previous years, I am taking this opportunity to highlight a few of our company’s many accomplishments in 2022 and identify a few of the many projects we will address in the year ahead.
In May, we announced that we’ve entered into a strategic partnership with Hitachi High-Tech (HHT). Together, we will advance precision medicine by providing solutions that improve the efficiency and accuracy of cancer diagnosis, prognosis and monitoring throughout the patient’s life.
We are pleased to have been selected as a partner for the Foundation for the National Institutes of Health (fNIH) Biomarkers Consortium on a new project to quantify and standardize MRD as a predictor of relapse for patients with acute myeloid leukemia (AML), and we look forward to participating using a combination of both next-generation sequencing (NGS), and multiparametric flow cytometry (MFC) assays. Our NGS assays are standardized and available worldwide; they target both FLT3 and NPM1, the most prevalent and important biomarkers in AML.
In addition, our 4 tube, CAP/CLIA validated AML MRD Assay on the 12-Color BD FACS Lyric has received great reviews testing blind peripheral blood and bone marrow specimens sent by pharma partners down to ~0.005% (LAIP dependent). This MFC assay identifies more than 20 surface markers on AML blasts from background hematopoietic cells with high sensitivity and specificity.
To fulfill an unmet need for FLT3 MRD, we introduced a next-generation sequencing (NGS)-based RUO FLT3 ITD MRD Assay, a 24-index kit and Dockerized FLT3 ITD MRD RUO software, enabling high-throughput laboratories to automate and streamline data analyses. This year we will also release an NGS-based RUO NPM1 MRD Assay with Dockerized NPM1 MRD RUO software. We also currently also offer RUO Dockerized LymphoTrack® Enterprise Software compatible with our RUO LymphoTrack clonality assays, enabling large laboratories to establish fully automated data pipelines.
In October, we filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for newly diagnosed AML patients with the FLT3-ITD mutation for Daiichi Sankyo’s investigational drug quizartinib.
This year we will be aligning our service offerings worldwide, including NGS tests, gene panels, bioinformatics, multiparametric flow cytometry assays and measurable residual disease (MRD) applications to support clinical and pharma partners around the world. To support continued growth in Asia, the Laboratory for Personalized Molecular Medicine (LabPMM) obtained ISO 15189 accreditation in Japan and Invivoscribe Diagnostic Technologies (Shanghai), Co., Ltd. in China obtained CAP accreditation in early 2023. Our China laboratory is our CRO hub for setting up, monitoring, and testing services in China. Central labs in China are expected to have accredited quality management systems to support registrational drug trials. By obtaining CAP accreditation at our China laboratory, Invivoscribe improved its ability to provide drug developers with a premium resource for molecular and flow-based oncology testing.
A new NGS-based service with unprecedented sensitivity, the B-cell MRD Assay, is now available across the LabPMM global network to monitor therapeutic response and serve as a surrogate endpoint in clinical trials.
In our endeavor for continuous improvement, our bioinformatics and R&D teams partnered together to develop an innovative approach of duplexed sequencing and tag-based error correction method in a myeloid gene panel assay to improve sequencing accuracy. Our bioinformatics team also developed SNPrint, a customizable genotyping application developed for our NGS-based gene panels, MyAML®, and MyMRD® to minimize the risk of sample mix-ups.
This year we returned to live conferences, attending multiple conferences across the world where we were able to meet with many of you for the first time in years. We are happy to report that research has commenced in laboratories across the world and our customers generated nearly 50 peer-reviewed scientific publications generated using Invivoscribe products.
The remarkable people at Invivoscribe and LabPMM continue to relentlessly push the limits, working to provide very progressive milestones in the upcoming year:
We expect to be one of the first companies in the world to receive IVDR approval in the EU for our LeukoStrat CDx FLT3 Mutation Assay and the team is generating IVDR validation packages for multiple capillary and NGS assays for submission to the notified body. Additionally, an NGS-based RUO NPM1 MRD Assay kit will be coming to market —enabling in-house therapeutic monitoring of AML patients.
Our teams are working to introduce a powerful, 11-color multiparametric flow cytometry (MFC) panel, the CLL MRD Assay, which will be provided as a CLIA-validated service throughout our LabPMM global network. The CLL MRD assay will be followed by an array of upcoming MFC-based MRD assays, targeting e.g., B-ALL and Multiple Myeloma.
Finally, I want to acknowledge that our growth and accomplishments over nearly 30 years, would not be possible without your feedback and support. We look forward to continued collaboration with research and clinical colleagues to ensure that we can continue to offer you cutting edge products and services for decades to come.
We wish you, your colleagues, and your families a safe, joyful, productive, and successful 2023.
Sincerely Yours,
Jeffrey Edward Miller, Ph.D.
Founder, Chief Scientific Officer, Chief Executive Officer & Chairman
INDUSTRY PIONEERS
We are the foremost experts in providing molecular products and services for oncology testing.
Invivoscribe offers a full range of oncology testing products and services (B- and T-cell clonality, NGS gene panels, MRD assays, and comprehensive bioinformatics software), all developed under ISO 13485 design control and manufactured in our cGMP facility.
Dear Colleagues:
As we begin 2023, I want to take a moment to express gratitude to our customers for your hard work and dedication and, further, your feedback on our products that you have provided over the past year. Our mission is to improve patient lives by providing standardized, innovative precision diagnostics. Improving the quality of healthcare worldwide is not easy, and it cannot be achieved alone, so – Thank you!
As in previous years, I am taking this opportunity to highlight a few of our company’s many accomplishments in 2022 and identify a few of the many projects we will address in the year ahead.
In May, we announced that we’ve entered into a strategic partnership with Hitachi High-Tech (HHT). Together, we will advance precision medicine by providing solutions that improve the efficiency and accuracy of cancer diagnosis, prognosis and monitoring throughout the patient’s life.
We are pleased to have been selected as a partner for the Foundation for the National Institutes of Health (fNIH) Biomarkers Consortium on a new project to quantify and standardize MRD as a predictor of relapse for patients with acute myeloid leukemia (AML), and we look forward to participating using a combination of both next-generation sequencing (NGS), and multiparametric flow cytometry (MFC) assays. Our NGS assays are standardized and available worldwide; they target both FLT3 and NPM1, the most prevalent and important biomarkers in AML.
In addition, our 4 tube, CAP/CLIA validated AML MRD Assay on the 12-Color BD FACS Lyric has received great reviews testing blind peripheral blood and bone marrow specimens sent by pharma partners down to ~0.005% (LAIP dependent). This MFC assay identifies more than 20 surface markers on AML blasts from background hematopoietic cells with high sensitivity and specificity.
To fulfill an unmet need for FLT3 MRD, we introduced a next-generation sequencing (NGS)-based RUO FLT3 ITD MRD Assay, a 24-index kit and Dockerized FLT3 ITD MRD RUO software, enabling high-throughput laboratories to automate and streamline data analyses. This year we will also release an NGS-based RUO NPM1 MRD Assay with Dockerized NPM1 MRD RUO software. We also currently also offer RUO Dockerized LymphoTrack® Enterprise Software compatible with our RUO LymphoTrack clonality assays, enabling large laboratories to establish fully automated data pipelines.
In October, we filed a supplemental Pre-Market Approval (sPMA) submission with the U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) for the use of the LeukoStrat® CDx FLT3 Mutation Assay as the companion diagnostic for newly diagnosed AML patients with the FLT3-ITD mutation for Daiichi Sankyo’s investigational drug quizartinib.
This year we will be aligning our service offerings worldwide, including NGS tests, gene panels, bioinformatics, multiparametric flow cytometry assays and measurable residual disease (MRD) applications to support clinical and pharma partners around the world. To support continued growth in Asia, the Laboratory for Personalized Molecular Medicine (LabPMM) obtained ISO 15189 accreditation in Japan and Invivoscribe Diagnostic Technologies (Shanghai), Co., Ltd. in China obtained CAP accreditation in early 2023. Our China laboratory is our CRO hub for setting up, monitoring, and testing services in China. Central labs in China are expected to have accredited quality management systems to support registrational drug trials. By obtaining CAP accreditation at our China laboratory, Invivoscribe improved its ability to provide drug developers with a premium resource for molecular and flow-based oncology testing.
A new NGS-based service with unprecedented sensitivity, the B-cell MRD Assay, is now available across the LabPMM global network to monitor therapeutic response and serve as a surrogate endpoint in clinical trials.
In our endeavor for continuous improvement, our bioinformatics and R&D teams partnered together to develop an innovative approach of duplexed sequencing and tag-based error correction method in a myeloid gene panel assay to improve sequencing accuracy. Our bioinformatics team also developed SNPrint, a customizable genotyping application developed for our NGS-based gene panels, MyAML®, and MyMRD® to minimize the risk of sample mix-ups.
This year we returned to live conferences, attending multiple conferences across the world where we were able to meet with many of you for the first time in years. We are happy to report that research has commenced in laboratories across the world and our customers generated nearly 50 peer-reviewed scientific publications generated using Invivoscribe products.
The remarkable people at Invivoscribe and LabPMM continue to relentlessly push the limits, working to provide very progressive milestones in the upcoming year:
We expect to be one of the first companies in the world to receive IVDR approval in the EU for our LeukoStrat CDx FLT3 Mutation Assay and the team is generating IVDR validation packages for multiple capillary and NGS assays for submission to the notified body. Additionally, an NGS-based RUO NPM1 MRD Assay kit will be coming to market —enabling in-house therapeutic monitoring of AML patients.
Our teams are working to introduce a powerful, 11-color multiparametric flow cytometry (MFC) panel, the CLL MRD Assay, which will be provided as a CLIA-validated service throughout our LabPMM global network. The CLL MRD assay will be followed by an array of upcoming MFC-based MRD assays, targeting e.g., B-ALL and Multiple Myeloma.
Finally, I want to acknowledge that our growth and accomplishments over nearly 30 years, would not be possible without your feedback and support. We look forward to continued collaboration with research and clinical colleagues to ensure that we can continue to offer you cutting edge products and services for decades to come.
We wish you, your colleagues, and your families a safe, joyful, productive, and successful 2023.
Sincerely Yours,
Jeffrey Edward Miller, Ph.D.
Founder, Chief Scientific Officer, Chief Executive Officer & Chairman
As a leading industry pioneer in the molecular diagnostic field, we are dedicated to improving the standard of healthcare worldwide.
We offer clinical laboratories, pharmaceutical companies, physicians, patients, and researchers high quality, reliable, and innovative molecular diagnostic solutions. These solutions range from CDx biomarker identification and patient stratification to assay development and reagent manufacturing, to the commercialization of these assays either as services at our harmonized clinical laboratories or as kits available to laboratories in over 160 countries.
As a leading industry pioneer in the molecular diagnostic field, we are dedicated to improving the standard of healthcare worldwide.
We offer clinical laboratories, pharmaceutical companies, physicians, patients, and researchers high quality, reliable, and innovative molecular diagnostic solutions. These solutions range from CDx biomarker identification and patient stratification to assay development and reagent manufacturing, to the commercialization of these assays either as services at our harmonized clinical laboratories or as kits available to laboratories in over 160 countries.
We strive to unlock and make accessible, the full potential of personalized molecular medicine, as we know the molecular basis behind each person’s disease is different.
As a reagent manufacturer, we offer a comprehensive selection of gel, capillary, and next-generation sequencing PCR assays for gene rearrangement, chromosome translocation, and gene mutation detection. These products are available through our global distribution network and are currently used in over 700 laboratories.
We strive to unlock and make accessible, the full potential of personalized molecular medicine, as we know the molecular basis behind each person’s disease is different.
As a reagent manufacturer, we offer a comprehensive selection of gel, capillary, and next-generation sequencing PCR assays for gene rearrangement, chromosome translocation, and gene mutation detection. These products are available through our global distribution network and are currently used in over 700 laboratories.
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The Latest Publications, News, Articles and Press Releases
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Invivoscribe Newsroom
The Latest News, Articles, and Press Releases from Invivoscribe
