Company – Experts in Molecular Products and Services For Oncology Testing2021-04-12T19:05:17+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 highlight a few of our company’s accomplishments from last year and identify a few of the many projects we will address in the coming year.

The pandemic that became apparent to us in the first quarter of 2020 understandably had a significant impact on our entire international staff and all of our customers worldwide last year. However, our executive and human resources team anticipated and prepared for teams working offsite, and our supervisors, LabPMM clinical, and Invivoscribe teams worldwide rapidly implemented and adjusted to new workflows, new schedules to address social distancing on site, and working with their families to adjust to keeping our business processes and momentum going while working from home. So, despite COVID-19-precipitated challenges, Invivoscribe remained focused and productive, completing, on time, projects for our partners, advancing internal projects, all combining to achieve high double-digit year over year revenue growth for the company.

To highlight just a few of the accomplishments our team members achieved in 2020:

To offer timely screening for our onsite employees, as well as to expand test availability in our local community, our team at LabPMM launched RT-qPCR COVID-19 testing at our CLIA/CAP, NY State Licensed reference laboratory in San Diego, CA.

Invivoscribe (IVS) received FDA regulatory approval for LeukoStrat® CDx FLT3 Mutation Assay as a distributable kit, providing customers with a choice to use this internationally-standardized signal ratio assay for in-house testing.  The ability to perform efficient, accurate, and objective FLT3 testing at regional laboratories, cancer treatment centers, and hospitals is expected to improve the management of patients diagnosed with acute myelogenous leukemia (AML).

We completed the buildout and launch of our wholly-owned laboratory in Shanghai, China. The laboratory was completed, equipped, and staff were hired and trained just as the pandemic was starting to impact travel, so tours of our new facility and opening ceremonies were done remotely. The lab personnel expand and complement our international LabPMM team beyond the staff in the US, Germany and Japan. Testing is already underway, and will soon offer the entire menu of PCR capillary assays, NGS tests, gene panels, bioinformatics, and multiparameter flow cytometry screening and MRD panels that will also be offered in LabPMM laboratories around the world.

Our new drug development entity, Invivoscribe Therapeutics, in-licensed a small molecule program from a UK based drug discovery service provider Domainex. This program has a first in class compounds that target novel pathways critical for myeloid malignancies like AML. Invivoscribe Therapeutics has already advanced the program to define the therapeutic rationale using pharmacology models and in vitro testing using primary tumor specimens from patient samples. GLP studies and compound manufacturing for clinic are on track. As a part of pipeline expansion, we are now actively conducting diligence to in-license a second program that is Phase 2 ready.

Invivoscribe expanded its R&D team in San Diego by 30% to develop a variety of assays. We 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.

Our flow cytometry team, working in concert with our clinical laboratories and our therapeutics division, developed screening and viability assays for a variety of hematologic malignancies as well as a standardized MRD panel to track AML. These panels will be available both in San Diego and China starting early this year and will be used for both internal and external drug development projects. We expanded collection, flow and genomic cataloging and viable freezing of primary tumor specimens for in vitro drug viability, drug panel screening, and IC50 drug studies.

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 by an online seminar at AMP.

We developed novel gene expression assays for ABI7500 Dx platform to support internal and external pharmaceutical partners, and we are developing 2nd generation MyAML® and MyMRD® gene panels with more genes and better sensitivity to discover and monitor variants such as TP53 in myeloid malignancies including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and myelodysplastic syndromes (MDS).

Finally, as always, I want to acknowledge that our growth and progress over these past 26 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 2021.

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 highlight a few of our company’s accomplishments from last year and identify a few of the many projects we will address in the coming year.

The pandemic that became apparent to us in the first quarter of 2020 understandably had a significant impact on our entire international staff and all of our customers worldwide last year. However, our executive and human resources team anticipated and prepared for teams working offsite, and our supervisors, LabPMM clinical, and Invivoscribe teams worldwide rapidly implemented and adjusted to new workflows, new schedules to address social distancing on site, and working with their families to adjust to keeping our business processes and momentum going while working from home. So, despite COVID-19-precipitated challenges, Invivoscribe remained focused and productive, completing, on time, projects for our partners, advancing internal projects, all combining to achieve high double-digit year over year revenue growth for the company. 

To highlight just a few of the accomplishments our team members achieved in 2020:

To offer timely screening for our onsite employees, as well as to expand test availability in our local community, our team at LabPMM launched RT-qPCR COVID-19 testing at our CLIA/CAP, NY State Licensed reference laboratory in San Diego, CA.

Invivoscribe (IVS) received FDA regulatory approval for LeukoStrat® CDx FLT3 Mutation Assay as a distributable kit, providing customers with a choice to use this internationally-standardized signal ratio assay for in-house testing.  The ability to perform efficient, accurate, and objective FLT3 testing at regional laboratories, cancer treatment centers, and hospitals is expected to improve the management of patients diagnosed with acute myelogenous leukemia (AML).

We completed the buildout and launch of our wholly-owned laboratory in Shanghai, China. The laboratory was completed, equipped, and staff were hired and trained just as the pandemic was starting to impact travel, so tours of our new facility and opening ceremonies were done remotely. The lab personnel expand and complement our international LabPMM team beyond the staff in the US, Germany and Japan. Testing is already underway, and will soon offer the entire menu of PCR capillary assays, NGS tests, gene panels, bioinformatics, and multiparameter flow cytometry screening and MRD panels that will also be offered in LabPMM laboratories around the world.

Our new drug development entity, Invivoscribe Therapeutics, in-licensed a small molecule program from a UK based drug discovery service provider Domainex. This program has a first in class compounds that target novel pathways critical for myeloid malignancies like AML. Invivoscribe Therapeutics has already advanced the program to define the therapeutic rationale using pharmacology models and in vitro testing using primary tumor specimens from patient samples. GLP studies and compound manufacturing for clinic are on track. As a part of pipeline expansion, we are now actively conducting diligence to in-license a second program that is Phase 2 ready.

Invivoscribe expanded its R&D team in San Diego by 30% to develop a variety of assays. We 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.

Our flow cytometry team, working in concert with our clinical laboratories and our therapeutics division, developed screening and viability assays for a variety of hematologic malignancies as well as a standardized MRD panel to track AML. These panels will be available both in San Diego and China starting early this year and will be used for both internal and external drug development projects. We expanded collection, flow and genomic cataloging and viable freezing of primary tumor specimens for in vitro drug viability, drug panel screening, and IC50 drug studies.

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 by an online seminar at AMP.

We developed novel gene expression assays for ABI7500 Dx platform to support internal and external pharmaceutical partners, and we are developing 2nd generation MyAML® and MyMRD® gene panels with more genes and better sensitivity to discover and monitor variants such as TP53 in myeloid malignancies including acute myeloid leukemia (AML), myeloproliferative neoplasms (MPN) and myelodysplastic syndromes (MDS).

Finally, as always, I want to acknowledge that our growth and progress over these past 26 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 2021.

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.