Novodiax launches ihcDirect® CD20 and ihcDirect Vimentin antibody assays.
Hayward, CA, December 16, 2018– Novodiax Inc., a leader in intraoperative immunohistochemistry (IHC) technology, announces the availability of two new ihcDirect staining kits for in vitro diagnostic (IVD) use: CD20 and Vimentin. “These two new products demonstrate our commitment to deliver rapid 10-minute IHC test results on frozen tissues to improve patient care for hospitals and clinicians,” said Jianfu Wang, PhD, CEO of Novodiax.
ihcDirect Oncology assays can help reduce surgeon wait times for histology results from hours to minutes, thus speeding the clinical interpretation of tissue staining patterns and helping to improve efficiencies in medical institutions, while often eliminating subsequent follow up visits and surgeries.
- The ihcDirect CD20 Ab (B-lymphocyte antigen) is present in a majority of B-cells in peripheral blood and lymphoid tissues. The antibody is used in several biomarker test panels to help differentiate B-cell lymphoma from other neoplasms. It may also be used in conjunction with other markers such as CD45 to gain a broader understanding of leukocytes to help identify B-cell and T-cell lymphomas.
- The ihcDirect Vimentin assay is an intermediate filament protein found in a variety of mesenchymal cells, including melanocytes, lymphocytes, endothelial cells and fibroblasts. ihcDirect Vimentin assay is often used in the differential diagnosis of undifferentiated neoplasms including melanoma, lymphoma and sarcoma as Vimentin is found in many types of sarcomas and lymphomas. Positive staining for Vimentin is seen in most cells of fibrosarcoma, liposarcomas, malignant fibrous histocytomas, angiosarcomas, chondrosarcomas and lymphomas.
Novodiax’s patent pending technology reduces the number of test steps when compared to traditional IHC test methods by eliminating the need for secondary antibodies and subsequent wash steps. All Novodiax ihcDirect reagents and test kits use the same 10-minute test turnaround protocol for frozen tissues. All currently available tests can also be performed using formalin-fixed paraffin-embedded (FFPE) tissues. These ready-to-use immunohistochemistry reagents and antibody test kits can be purchased as individual reagents or as a complete test kit. Test results for these products should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls. These products are intended for in vitro diagnostic (IVD) use.
Novodiax, Inc. is a privately held company founded in 2009 and dedicated to advancing tissue-based and cell-based diagnostics and immunoassays. The company developed the innovative ihcDirect platform allowing rapid determination of tissue during intraoperative procedures and is exploring applications for companion diagnostics. For further information visit our website at www.novodiax.com.
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