Company – Experts in Molecular Products and Services For Oncology Testing2022-05-12T15:32:39+00:00
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 in years past, I am taking this opportunity to highlight a few of our company’s many accomplishments in 2021 and identify a few of the many projects we will address in the coming year.

To highlight just a few of the accomplishments our team members achieved in 2021:

Invivoscribe evolved its Quality Management System (QMS) to meet the IVDR requirements and submitted the first class C CDx package for IVDR review to our notified body, helping cement our role as a leader in ensuring state of the art targeted therapies are supported in the EU.

Invivoscribe’s software and bioinformatics teams finalized development and launched updated MRD Software that allows simultaneous tracking of up to five separate biomarkers using our LymphoTrack® assays.

Our bioinformatics team, working with our flow team and under direction of our chief medical officer, developed and presented new machine learning algorithms to facilitate and complement manual interpretation of flow cytometry data by hematopathologists. Initial data from the algorithms were presented in a supplemental issue of Blood and in a poster at ASH.

We began work on moving bioinformatics software pipeline and reporting features to the cloud. When complete, we expect our portal will revolutionize and expand our commercial platform, providing access to bioinformatics pipeline and software for data analysis, interpretation for pharma partners and customers worldwide. In addition, we have started licensing an enterprise version of Invivoscribe’s LymphoTrack® Software to streamline data management at key cancer centers.

Invivoscribe expanded R&D, bioinformatics and software teams in San Diego in order to develop a variety of assays and furthered our collaboration with a number of clinical pharmaceutical partners using LymphoTrack IGH and TCR assays to support minimal residual disease (MRD) detection in international clinical studies of a wide range of hematologic malignancies, including multiple myeloma (MM), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), peripheral T-cell lymphomas (PTCL). A number of scientific papers and posters were also published or presented by clinical cancer centers using LymphoTrack® MRD assays. We had 34 peer-reviewed scientific papers published by global customers conducted using Invivoscribe products and participated in 13 international conferences.

LabPMM, our international clinical laboratory arm, expanded capabilities across sites via obtaining CAP/CLIA listing for flow in the US, validating additional flow lab and molecular testing capabilities in China, moving our EU lab to a larger more sophisticated facility in Munich, and submitting for ISO 15189 accreditation in Japan.  This year we will be offering an even more complete menu of PCR capillary assays, NGS tests, gene panels, bioinformatics, and multiparameter flow cytometry screening and MRD panels to support clinical and pharma partners in the LabPMM laboratories around the world.

Our flow cytometry team developed screening assays for hematologic malignancies. The CLIA-accredited 10-color Hematolymphoid Screening Panel provides a comprehensive approach to evaluate bone marrow and peripheral blood for the presence or absence of hematolymphoid malignancies. The team also developed and launched a 12-color flow MRD test for AML that tracks 21 biomarkers. These panels are currently being run in San Diego, but reagent set and software validations with the addition of cGMP manufacturing ensure that we can make these assays available in China and other LabPMM sites in the near future.

We are developing a pan cancer gene panel, and 2nd generation MyAML® and MyMRD® gene panels with more genes and better sensitivity to identify and monitor variants such as TP53 in solid tumors, myeloid malignancies, including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and myelodysplastic syndromes (MDS).

Some key Invivoscribe and LabPMM milestones that will be met this year include:

The team will be submitting for CAP accreditation of our Shanghai laboratory; finishing our ISO 15189 accreditation for our lab in Japan; earning our IVDR QMS accreditation at our San Diego headquarters; receiving LeukoStrat CDx FLT3 Mutation Assay approval through the new IVDR system in the EU; and generating IVDR validation packages for multiple capillary and NGS assays in the queue for submission to our notified body.  Additionally, we will be finalizing development and release an NGS-based B-cell MRD Assay, an MRD Myeloid Assay, and machine learning algorithms to assist in streamlining flow analyses in our clinical laboratories worldwide.

Finally, I want to acknowledge that our growth and progress over these past 28 years would not be possible without your feedback and support. We look forward to continued interaction with research and clinical colleagues to ensure we can continue to offer you the best products for decades to come.

We wish you, your colleagues, and your families a safe, joyful, productive, and successful 2022.

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:

I am pleased to introduce Invivoscribe’s 2022 Product Catalog.  As in years past, I am taking this opportunity to highlight a few of our company’s many accomplishments in 2021 and identify a few
of the many projects we will address in the coming year.

To highlight just a few of the accomplishments our team members achieved in 2021:

Invivoscribe evolved its Quality Management System (QMS) to meet the IVDR requirements and submitted the first class C CDx package for IVDR review to our notified body, helping cement our role as a leader in ensuring state of the art targeted therapies are supported in the EU.

Invivoscribe’s software and bioinformatics teams finalized development and launched updated MRD Software that allows simultaneous tracking of up to five separate biomarkers using our LymphoTrack® assays.

Our bioinformatics team, working with our flow team and under direction of our chief medical officer, developed and presented new machine learning algorithms to facilitate and complement manual interpretation of flow cytometry data by hematopathologists. Initial data from the algorithms were presented in a supplemental issue of Blood and in a poster at ASH.

We began work on moving bioinformatics software pipeline and reporting features to the cloud. When complete, we expect our portal will revolutionize and expand our commercial platform, providing access to bioinformatics pipeline and software for data analysis, interpretation for pharma partners and customers worldwide. In addition, we have started licensing an enterprise version of Invivoscribe’s LymphoTrack® Software to streamline data management at key cancer centers.

Invivoscribe expanded R&D, bioinformatics and software teams in San Diego in order to develop
a variety of assays and furthered our collaboration with a number of clinical pharmaceutical partners using LymphoTrack IGH and TCR assays to support minimal residual disease (MRD) detection
in international clinical studies of a wide range of hematologic malignancies, including multiple myeloma (MM), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), peripheral
T-cell lymphomas (PTCL). A number of scientific papers and posters were also published or presented by clinical cancer centers using LymphoTrack® MRD assays. We had 34 peer-reviewed scientific papers published by global customers conducted using Invivoscribe products and participated in 13 international conferences.

LabPMM, our international clinical laboratory arm, expanded capabilities across sites via obtaining CAP/CLIA listing for flow in the US, validating additional flow lab and molecular testing capabilities
in China, moving our EU lab to a larger more sophisticated facility in Munich, and submitting for ISO 15189 accreditation in Japan.  This year we will be offering an even more complete menu of PCR capillary assays, NGS tests, gene panels, bioinformatics, and multiparameter flow cytometry screening and MRD panels to support clinical and pharma partners in the LabPMM laboratories around
the world.

Our flow cytometry team developed screening assays for hematologic malignancies. The CLIA-accredited 10-color Hematolymphoid Screening Panel provides a comprehensive approach
to evaluate bone marrow and peripheral blood for the presence or absence of hematolymphoid malignancies. The team also developed and launched a 12-color flow MRD test for AML that tracks
21 biomarkers. These panels are currently being run in San Diego, but reagent set and software validations with the addition of cGMP manufacturing ensure that we can make these assays available in China and other LabPMM sites in the near future.

We are developing a pan cancer gene panel, and 2nd generation MyAML® and MyMRD® gene panels with more genes and better sensitivity to identify and monitor variants such as TP53 in solid tumors, myeloid malignancies, including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN), and myelodysplastic syndromes (MDS).

Some key Invivoscribe and LabPMM milestones that will be met this year include:

The team will be submitting for CAP accreditation of our Shanghai laboratory; finishing our ISO 15189 accreditation for our lab in Japan; earning our IVDR QMS accreditation at our San Diego headquarters; receiving LeukoStrat CDx FLT3 Mutation Assay approval through the new IVDR system in the EU; and generating IVDR validation packages for multiple capillary and NGS assays in the queue for submission to our notified body.  Additionally, we will be finalizing development and release an NGS-based B-cell MRD Assay, an MRD Myeloid Assay, and machine learning algorithms to assist in streamlining flow analyses in our clinical laboratories worldwide.

Finally, I want to acknowledge that our growth and progress over these past 27 years would not be possible without your feedback and support. We look forward to continued interaction with research and clinical colleagues to ensure we can continue to offer you the best products for decades to come.

We wish you, your colleagues, and your families a safe, joyful, productive, and successful 2022.

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.

Products

Best in class assays and reagents

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.

Clinical Lab Services

LabPMM offers clinical services with global reach

The Laboratory for Personalized Molecular Medicine® (LabPMM®) at Invivoscribe offer internationally harmonized testing of novel and proprietary biomarkers that are critically important for patient care.

Partnerships

CDx Turn-Key Collaboration

Invivoscribe provides a proven strategy to accelerate drug approvals, offering Product Development, Manufacturing, Clinical Lab Services and Global Regulatory Expertise.

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.

Products

Best in class assays and reagents

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.

Clinical Lab Services

LabPMM offers clinical services with global reach

The Laboratory for Personalized Molecular Medicine® (LabPMM®) at Invivoscribe offer internationally harmonized testing of novel and proprietary biomarkers that are critically important for patient care.

Partnerships

CDx Turn-Key Collaboration

Invivoscribe provides a proven strategy to accelerate drug approvals, offering Product Development, Manufacturing, Clinical Lab Services and Global Regulatory Expertise.

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.

20-30% of patients with acute myeloid leukemia have mutations of the FLT3 biomarker that make them eligible for several FLT3-targeted small molecule therapies currently in late stage clinical trials. Interim results indicate that FLT3-targeted drugs may improve survival and “obviate the need for allogeneic stem cell transplantation”. If these results are confirmed and one or more of these FLT3-targeted drugs become approved by the FDA, testing for the FLT3 biomarker may eliminate the need for thousands of patients to undergo stem cell transplantation (each allogeneic transplant costs hundreds of thousands of dollars and place recipients at grave risk of infection and other complications such as Graft vs. Host disease). Accordingly, the companion diagnostic FLT3 diagnostic test will provide access to a FLT3small molecular inhibitor, which could result in improved survival coupled with cost savings of tens of thousands of dollars per AML patient. As there are more than thirty thousand new AML patients identified each year, this could result in hundreds of millions of dollars per year in potential cost savings. Further, these targeted therapies generally have substantively reduced side effects relative to those of standard chemotherapy, so the quality of life for the patient is potentially much improved.

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