Hematopathology
Invivoscribe focuses on developing tests for hematopathology and hematology/oncology, which are exciting fields in terms of the rapid evolution and impact of personalized medicine. Invivoscribe manufactures diagnostic kits used to detect clonal gene rearrangements, gene translocations, and gene mutations. Products include CE-Marked IVD products that are used extensively for diagnosis and prognosis outside North America, and Analyte Specific Reagents (ASRs), which are used by CLIA-accredited high-complexity laboratories here in the United States to develop their Laboratory Developed Tests.
One of Invivoscribe's standardized tests determines the mutation status of FLT3, an internationally recognized prognostic biomarker, which is used to stratify and determine treatment for patients with acute myelogenous leukemia (AML). FLT3 is a tyrosine kinase expressed at high levels in AML. Determining the mutation status of FLT3 has a significant prognostic value, as FLT3 mutation status is used to help determine if conventional treatment or other options might be considered for each individual patient. Our research focuses on results that enable physicians and patients to make the most informed and coherent treatment decisions. Working with hospitals and patient care facilities, as well as pharmaceutical companies, we play an important role in helping physicians provide a higher quality of customized care to their patients, while assisting pharmaceutical drug development.
In vivo cDNA synthesis Technologies
Our proprietary in vivo cDNA synthesis technologies are an exciting next-generation approach that may resolve and eliminate many of the problems associated with delivery of healthcare in this 21st century. In our quest for standardization and harmonization of test results it is absolutely essential that we standardize specimen collection, stabilization, and transport. This is particularly true of tests that interrogate gene activity and endeavor to make determinations based upon their findings. Cancers are not homogeneous cell populations, they are heterogeneous collections of cells and they are almost invariably collected with various numbers of normal cells. Normal cells invariably complicate the analyses of studies done on cancer that look at RNAs, as normal cells contribute to the overall signal for each RNA. So, to achieve consistent, valid gene expression profiles it would be wonderful if we could stabilize all RNAs, and then remove the contribution from normal cells. Our proprietary in vivo cDNA synthesis technologies hold the promise of achieving this goal.