Commercialization of Intellectual Property

Invivoscribe is currently working on a number of new products and technologies for hematology/oncology. We welcome learning of new licensing opportunities for intellectual property around biomarkers and technologies that have demonstrated clinical utility in hematology/oncology, personalized molecular diagnostics, and personalized molecular medicine. We are the world leader in developing, commercializing, and adding value to intellectual property in these fields, and we have committed and will continue to commit significant resources to enhancing the value and breadth of coverage of our patents and patents we in-license from others.

Invivoscribe strives to keep current with advances in molecular diagnostics. In 2006 a group from our company traveled to Japan to secure a worldwide exclusive license (ex-Japan) to a series of patents that allow us to offer FLT3 mutation testing. This laboratory test is used to determine the mutation status of the FLT3 gene, which has demonstrated ability to predict a patient's likelihood to benefit from therapy as well as their risk of experiencing a disease recurrence. Assessment of FLT3 mutation status is recommended for all patients with acute myelogenous leukemia (AML) by the National Comprehensive Cancer Network (NCCN) and World Health Organization (WHO) clinical practice guidelines. In fact, FLT3 mutation testing is designated a "Standard of Care" for patients diagnosed with AML.

In December 2008 LabPMM, a subsidiary of Invivoscribe obtained a license to perform NPM1 mutation testing. Accordingly, NPM1 mutation testing complements LabPMM's exclusive license to test for FLT3 activating mutations. Assessment of FLT3 and NPM1 mutation status has become an internationally recognized Standard of Care for patients with acute myeloid leukemia. LabPMM is the leading provider of FLT3 screening, and the only clinical reference lab licensed to perform FLT3 testing outside of Japan.

Many studies have shown that AML patients with FLT3 mutations have poor cure rates due to relapse. Fortunately, clinical trials involving FLT3 inhibitors are being performed by several pharmaceutical companies. For inclusion in the trials, most require testing to confirm the presence of the FLT3 mutation.

LabPMM's license includes the ability to monitor patients using ultra-sensitive minimal residual disease (MRD) tests. Presence of NPM1 mutations in patients with karyotype normal acute myeloid leukemia (AML) portends a more favorable prognosis than patients that lack NPM1 mutations. While presence of FLT3 activating mutations portends a very poor prognosis for patients with AML, when FLT3 and NPM1 mutations are both present the overall prognosis for the patient is somewhat more favorable. Testing the mutation status of both of these biomarkers is necessary for disease stratification and optimal treatment selection for patients with AML.

FLT3 Mutation Detection
NPM1 Mutation Detection
AML Test Panel