KEYTRUDA is approved by the FDA to treat patients with metastatic NSCLC whose tumors express PD-L1 as determined by the companion diagnostic assay
and who have disease progression on or after platinum-containing chemotherapy.
Graham Mullis, CEO of Lab21, commented: "We are pleased to enter into a new companion diagnostic assay
partnership with a major pharma company to develop and co-brand this assay.
Mara G Aspinall, stated : "In line with our mission to improve the lives of all patients afflicted with cancer, our collaboration with Pfizer and the launch of the VENTANA ALK IHC companion diagnostic assay
is another strong example of our commitment to enabling Personalized Healthcare for patients worldwide and being the Pharma Partner of Choice".
The association allows further development of Eutropics proprietary BH3 profiling diagnostic assay
for personalized medicine approaches in patient management of AML, a cancer of the blood and bone.
Finally, an important aspect in developing a diagnostic assay
is to use a rapid and easily automated system that works on virtually all persons who carry the disease.
Improper normalization can affect the magnitude and even the direction (up or down) of change in miRNA gene expression in diseased clinical samples, such as tumor specimens, and is critical for the development of robust and reliable research and diagnostic assays
The acquisition is a natural next step on our path in entering diagnostic assay
control and calibrator manufacturing, and mirrors Fujirebio Diagnostics' strategy to provide its diagnostic industry customers with the tools and services that will revolutionize how disease is diagnosed and managed.
Asuragen's business model of providing GLP molecular biology services, CLIA testing capabilities, and GMP diagnostic assay
development and manufacture is uniquely suited to collaborate with pharmaceutical partners in the clinical validation of drugs in development and the potential future companion diagnostic tests," said Matt Winkler, Ph.
Title: "Development and validation of a microRNA-based diagnostic assay
for the classification of renal cell tumors" Abstract number: 802 Summary: This poster describes the development and validation of the miRview[sup.
The Mayo Clinic, one of the premier healthcare and research institutions in the world, and the Company are jointly conducting a broad validation study of Biomoda's patented technology, a non-invasive cytology based lung cancer diagnostic assay
where he and the team transformed the company from a research and market development focus to full commercialization of a novel molecular diagnostic assay
in a Clinical Laboratory Improvements Amendments (CLIA) certified laboratory.
We're inviting researchers to participate in this open access online community so we all might better understand the meaning and value of diagnostic assay
results - all in a secure, members-only forum.
With this agreement, we expand availability of Saladax's My5-FU diagnostic assay
in the global market.
Centers for Disease Control and Prevention (CDC) to develop a unique multi-analyte Point-Of-Care (POC) diagnostic assay
for Influenza in support of the US Government's efforts to strengthen its readiness for a potential influenza pandemic.
Nephroscreen(TM) is an RUO diagnostic assay
based on the detection of adenosine deaminase binding protein (ABP), which is released from brush border epithelial cells into the urine as a consequence of renal disease and damage to the proximal tubules.