Company – Experts in Molecular Products and Services For Oncology Testing2025-07-16T16:56:53-07:00
30 YEARS EXPERIENCE

Improving Lives with Precision Diagnostics®

30 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
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.

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 standardized 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 standardized 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 standardized 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 standardized 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.