Company2020-09-17T01:03:10+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 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:

I am pleased to take this opportunity to share some of last year’s accomplishments.

Total year over year revenue grew over 30%, supported by new tests, menu items, adoption of our suite of LymphoTrack® assays that include bioinformatics software, and our LeukoStrat® FLT3 CDx Mutation Assay.

Invivoscribe (IVS) received several regulatory approvals for the internationally-standardized FLT3 signal ratio test, including approval of the CDx claim for quizartinib in Japan. We submitted a CDx distributable kit package to the US FDA so we anticipate we will be able to sell a FLT3 CDx kit in the US later this year. We also finalized several new CDx partnership projects: one for a new CDx assay on the 7500 Fast Dx instrument, and one with a previous partner. We will announce these deals early in 2020.

IVS participated in over 30 conferences and tradeshows worldwide, presenting 8 posters and publishing 2 scientific papers with participation from our R&D, LabPMM and bioinformatics groups. A number of scientific papers and posters were also published or presented by customers using our products.

IVS launched MRD controls for both B- and T-cell assays with our comprehensive suite of LymphoTrack Clonality Assays, including LymphoTrack® software for Illumina® NGS platforms. These assays 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 users 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. These RUO assays are being used with accompanying minimal residual disease (MRD) bioinformatics software in international studies of a wide range of hematologic malignancies, including multiple myeloma and acute lymphoblastic leukemia. The assays will be submitted for review via the US FDA’s 510(k) process and with the appropriate regulatory authorities worldwide.

We also finished development of a TRG MiSeqDx 510(k) assay; released LymphoTrack® Dx assays for ThermoFisher NGS platforms, and started working under an exclusive agreement with the BIOMED-2 /EuroClonality Consortium in Europe to develop and commercialize their NGS-based assays.

In addition, we made substantial progress building out a new wet lab in Shanghai to add further capabilities for clinical programs to support our pharma partners in China, expanded operations and capabilities at our clinical labs in the US, Japan, the EU, and established an entirely new line of business: setting up a flow cytometry lab so we can soon offer both flow- and NGS-based MRD testing intramurally on exactly the same primary specimens.

We developed a number of engineered cell lines using CRISPR technology, a highly sensitive assay on a digital droplet PCR platform, and filed a number of patents. Still further, we launched a wholly-owned drug development company, Invivoscribe Therapeutics, that has already started testing a small molecule that targets myeloid malignancies.

In 2019 our entire range of tests, including MyAML®, and MyMRD® gene panels with our MyInformatics® bioinformatics pipeline, received increased traction and use by more than three dozen pharmaceutical partners. These tests are available as RUO and/or CLIA/CAP listed tests through our LabPMM clinical laboratories in the USA, Europe, and Asia.

Finally, I want to acknowledge that our continued growth and progress over these past 25 years would not be possible without our customer’s feedback and support. We look forward to continued interaction with the research and clinical communities so we can offer you the best products for decades to come and we wish you, your colleagues, and your families a joyful, productive, and successful 2020.

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 take this opportunity to share some of last year’s accomplishments.

Total year over year revenue grew over 30%, supported by new tests, menu items, adoption of our suite of LymphoTrack® assays that include bioinformatics software, and our LeukoStrat® FLT3 CDx Mutation Assay.

Invivoscribe (IVS) received several regulatory approvals for the internationally-standardized FLT3 signal ratio test, including approval of the CDx claim for quizartinib in Japan. We submitted a CDx distributable kit package to the US FDA so we anticipate we will be able to sell a FLT3 CDx kit in the US later this year. We also finalized several new CDx partnership projects: one for a new CDx assay on the 7500 Fast Dx instrument, and one with a previous partner. We will announce these deals early in 2020.

IVS participated in over 30 conferences and tradeshows worldwide, presenting 8 posters and publishing 2 scientific papers with participation from our R&D, LabPMM and bioinformatics groups. A number of scientific papers and posters were also published or presented by customers using our products.

IVS launched MRD controls for both B- and T-cell assays with our comprehensive suite of LymphoTrack Clonality Assays, including LymphoTrack® software for Illumina® NGS platforms. These assays 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 users 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. These RUO assays are being used with accompanying minimal residual disease (MRD) bioinformatics software in international studies of a wide range of hematologic malignancies, including multiple myeloma and acute lymphoblastic leukemia. The assays will be submitted for review via the US FDA’s 510(k) process and with the appropriate regulatory authorities worldwide.

We also finished development of a TRG MiSeqDx 510(k) assay; released LymphoTrack® Dx assays for ThermoFisher NGS platforms, and started working under an exclusive agreement with the BIOMED-2 /EuroClonality Consortium in Europe to develop and commercialize their NGS-based assays.

In addition, we made substantial progress building out a new wet lab in Shanghai to add further capabilities for clinical programs to support our pharma partners in China, expanded operations and capabilities at our clinical labs in the US, Japan, the EU, and established an entirely new line of business: setting up a flow cytometry lab so we can soon offer both flow- and NGS-based MRD testing intramurally on exactly the same primary specimens.

We developed a number of engineered cell lines using CRISPR technology, a highly sensitive assay on a digital droplet PCR platform, and filed a number of patents. Still further, we launched a wholly-owned drug development company, Invivoscribe Therapeutics, that has already started testing a small molecule that targets myeloid malignancies.

In 2019 our entire range of tests, including MyAML®, and MyMRD® gene panels with our MyInformatics® bioinformatics pipeline, received increased traction and use by more than three dozen pharmaceutical partners. These tests are available as RUO and/or CLIA/CAP listed tests through our LabPMM clinical laboratories in the USA, Europe, and Asia.

Finally, I want to acknowledge that our continued growth and progress over these past 25 years would not be possible without our customer’s feedback and support. We look forward to continued interaction with the research and clinical communities so we can offer you the best products for decades to come and we wish you, your colleagues, and your families a joyful, productive, and successful 2020.

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.