Company2019-08-07T06:26:46+00:00
25 YEARS EXPERIENCE

Improving Lives with Precision Diagnostics®

25 YEARS EXPERIENCE

Improving Lives with
Precision Diagnostics®

INDUSTRY PIONEERS

We are the foremost experts in providing molecular products and services for leukemia and lymphoma testing.

Invivoscribe offers a full range of hematology-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:

I would like to take this opportunity to share some of our 2018 accomplishments and some of our future plans at Invivoscribe, starting with an update on companion diagnostics.

In 2018 we employed our Streamlined CDx program to quickly follow up on the 2017 FDA approval of our LeukoStrat® CDx FLT3 Mutation Assay in the US as a companion diagnostic (CDx) for patients with AML for whom the Novartis drug, midostaurin treatment is being considered, with use of this internationally standardized CDx to support two new pharmaceutical partners with two new targeted drugs. We received approval in both the US and Japan for the Astellas drug, gilteritinib, and we completed submissions in both the US and Japan for the Daiichi Sanko drug, quizartinib. We also received national reimbursement from the MHLW in Japan for this LeukoStrat® CDx.

In addition, we completed development and release of the entire suite of LymphoTrack® Assays and now offer a comprehensive menu of LymphoTrack Clonality Assays along with LymphoTrack software for Illumina® NGS platforms (RUO on page 43, and CE-IVD on page 28). LymphoTrack assays are used to identify and track clonal rearrangements within the antigen receptor loci (IGH, IGK, TRG, TRB). The 24 ID format (48 indices for the IGH FR1 Assay) allows customers to significantly reduce costs, as you can run any combination of the 7 assays (up to 178 samples with 14 controls) simultaneously on one chip, as the accompanying bioinformatics software automatically sorts and interprets the data for each targeted region and sequence ID.

Our team enjoys seeing our RUO assays also being used in concert with accompanying minimal residual disease (MRD) bioinformatics software, for the study of MRD in a wide range of hematologic malignancies, including multiple myeloma and acute lymphoblastic leukemia. These clonality assays will be submitted for review via the US FDA’s 510(k) process.

Our MyAML®, MyMRD®, and MyHeme® gene panels, combined with our custom MyInformatics® bioinformatics pipeline are receiving more and more traction and use by pharmaceutical partners. They are available as RUO and/or CLIA/CAPlisted tests through our LabPMM clinical laboratories in the USA, Europe and Asia.

Our continued growth and progress would not be possible without your feedback and support. We look forward to continued interaction with the research and clinical communities so we can offer you the best molecular products for decades to come. We wish you, your colleagues, and your families a joyful, productive, and successful 2019.

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 leukemia and lymphoma testing.

Invivoscribe offers a full range of hematology-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 would like to take this opportunity to share some of our 2018 accomplishments and some of our future plans at Invivoscribe, starting with an update on companion diagnostics.

In 2018 we employed our Streamlined CDx program to quickly follow up on the 2017 FDA approval of our LeukoStrat® CDx FLT3 Mutation Assay in the US as a companion diagnostic (CDx) for patients with AML for whom the Novartis drug, midostaurin treatment is being considered, with use of this internationally standardized CDx to support two new pharmaceutical partners with two new targeted drugs. We received approval in both the US and Japan for the Astellas drug, gilteritinib, and we completed submissions in both the US and Japan for the Daiichi Sanko drug, quizartinib. We also received national reimbursement from the MHLW in Japan for this LeukoStrat® CDx.

In addition, we completed development and release of the entire suite of LymphoTrack® Assays and now offer a comprehensive menu of LymphoTrack Clonality Assays along with LymphoTrack software for Illumina® NGS platforms (RUO on page 43, and CE-IVD on page 28). LymphoTrack assays are used to identify and track clonal rearrangements within the antigen receptor loci (IGH, IGK, TRG, TRB). The 24 ID format (48 indices for the IGH FR1 Assay) allows customers to significantly reduce costs, as you can run any combination of the 7 assays (up to 178 samples with 14 controls) simultaneously on one chip, as the accompanying bioinformatics software automatically sorts and interprets the data for each targeted region and sequence ID.

Our team enjoys seeing our RUO assays also being used in concert with accompanying minimal residual disease (MRD) bioinformatics software, for the study of MRD in a wide range of hematologic malignancies, including multiple myeloma and acute lymphoblastic leukemia. These clonality assays will be submitted for review via the US FDA’s 510(k) process.

Our MyAML®, MyMRD®, and MyHeme® gene panels, combined with our custom MyInformatics® bioinformatics pipeline are receiving more and more traction and use by pharmaceutical partners. They are available as RUO and/or CLIA/CAPlisted tests through our LabPMM clinical laboratories in the USA, Europe and Asia.

Our continued growth and progress would not be possible without your feedback and support. We look forward to continued interaction with the research and clinical communities so we can offer you the best molecular products for decades to come. We wish you, your colleagues, and your families a joyful, productive, and successful 2019.

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 700 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 700 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.