Hayward, CA, March 06, 2019– Novodiax Inc. continues to demonstrate leadership in the intraoperative immunohistochemistry (IHC) testing market by releasing two new ihcDirect staining kits for in vitro diagnostic (IVD) use: Ki67 and EMA. “These two new products are positioned to support rapid 10-minute IHC testing on frozen tissues such as breast, prostate and glands,” said Jianfu Wang, PhD, CEO of Novodiax .
Novodiax oncology assays can help reduce surgeon wait times for histology results from hours or days to minutes, thus speeding the clinical interpretation of tissue staining patterns. These tests can also help improve efficiencies in medical institutions by speeding decisions and helping to eliminate subsequent follow up visits and surgeries.
- ihcDirect® Ki67 Ab is a polyHRP conjugated antibody. Ki67 is a nuclear protein expressed in all proliferating cells and is a widely used biomarker to estimate the proportio n of dividing cells to help grade human tumor cells. Ki67 has often been used as a marker of proliferation for tumor cells of the breast and
- The ihcDirect® EMA Ab is a broad-spectrum antibody conjugate that recognizes Epithelial Membrane Antigen, a large cell surface mucin O-glycosylated protein expressed by glandular and ductal epithelial cells and some hematopoietic cell lines for tissues that form mucous barriers on epithelial
- EMA, also known as MUC1, is present in many types of adenocarcinoma and can be useful in recognizing epithelial derivation of poorly differentiated malignant tumors. EMA is strongly positive for breast and skin adnexal tumors and is expressed by meningiomas, synovial sarcoma, epithelioidsarcoma, lymphocyte-predominant Hodgkin lymphoma, and anaplastic large-cell lymphomas (ALCL).
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 16 of the currently available tests can also be performed using formalin-fixed paraffin- embedded (FFPE) tissues. These ready-to-use immuno-histochemistry reagents and antibody test kits are available in convenient sizes. 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.
For further information visit our website at www.novodiax.com.