March 5, 2021 (Viz Release) – – Novodiax is excited to announce the release of four new assays intended to expand our rapid immunohistochemistry (IHC) thyroid panel for in vitro diagnostic (IVD) use. The new assays include: Galectin-3 (GAL3), parathyroid hormone (PTH), thyroperoxidase TPO and calcium signal transducer 2 (Trop2). These assays build off of other recently release assays: Chromogranin A (CgA,), CK19, Synaptophysin, and TTF1 that can also be used as a part of a thyroid cancer testing panel.
Novodiax continues to innovate and pioneer within the rapid IVD histology testing market working to make it possible for clinicians to impact patient care by providing very fast IHC tests to complete the whole testing process from tissue excision-to-actionable decision making in under 20 minutes. Today, ihcDirect(R) assays are being employed by many medical institutions and physicians wanting to gain valuable patient insights that only a rapid IHC antibody test can provide, especially related to identifying surgical margins, differential diagnosis or to more efficiently make medical decisions. CgA, CK19, GAL3, PTH, Synaptophysin, TPO, TROP2, and TTF1 can all be performed in 10-13 minutes all important market segment and demonstrate continued commitment to surgical pathology and cytology markets.
Adding rapid immunoassay tissue testing may help pathologists and surgeons more rapidly assess cancers of unknown origin, expand understanding past the typical H&E tests used for morphology assessment to provide more clear reading in certain tissue sections that may appear to be ambivalent or unclear. Novodiax ihcDirect assays may also be used to support clinical decisions such as being able to help justify tissue sparing protocols and/or fewer follow-up surgeries due to incomplete excision.
New ihcDirect assay Images
The ihcDirect GAL3, PTH, TPO and TROP2 assays utilize the proprietary Novodiax polymerized HRP chemistry which helps to improve staining sensitivity and increases test speed.
ihcDirect(R) GAL3 is normally distributed in epithelia of several organs, in inflammatory cells such as dendritic cells, macrophages and is associated with cell growth as well as adhesion, inflammation, mRNA processing, and apoptosis. GAL3 has been shown to be related to malignancies and metastasis of carcinomas in thyroid, breast and colon tissues. GAL3 when used with morphologic and other thyroid markers such as TROP2, TPO, CD56, and CK19 may be useful in differentiating between benign and malignant thyroid neoplasms.
ihcDirect(R) PTH Ab or parathyroid hormone is secreted from the chief cells of parathyroid glands and is the most important endocrine regulator of calcium and phosphorus concentrations in extracellular fluid. The cells of normal parathyroid gland, hyperplasia and adenoma are positive to PTH. The IHC staining of PTH is very useful in the diagnosis and differential diagnosis of tumors and hyperplasia of the parathyroid gland, as well as in localizing hyperfunctioning parathyroid tissue. PTH antibody is also useful to distinguish parathyroid hyperplasia/neoplasms from thyroid and metastatic neoplasms.
ihcDirect(R) Thyroid Peroxidase (TPO) Ab is a thyroid-specific enzyme involved in thyroid hormone synthesis and its gene expression is regulated by thyroid stimulating hormone. TPO is located in normal thyroid and thyroid carcinoma of papillary and follicular type. In normal thyroid tissue, expression of TPO may produce a diffuse, fine, granular cytoplasmic stain in follicular cells. TPO may aid pathologists to better differentiate benign from malignant thyroid neoplasms.
ihcDirect(R) TROP2 (calcium signal transducer 2) is a transmembrane glycoprotein and functions as an intracellular calcium signal transducer. It promotes cell regeneration, proliferation, invasion and survival in normal tissues. Trop2 mutations may result in gelatinous drop-like corneal dystrophy and it can be overexpressed in carcinomas which may promote increased tumor aggressiveness and metastasis. TROP2 may be found in colorectal, gastric and pancreatic cancers, squamous cell cancers of the oral cavity, non–small cell cancers of the lung, as well as endometrial and ovarian malignancies.
All of the ihcDirect(R) assays are ready-to-use and perform equally well in FFPE as well as frozen tissue histology sections. None of the assays requires any special handling such as heat-induced epitope retrieval (HIER) pretreatment or antigen retrieval of the tissue prior to running frozen tissue sections. These assays are convenient to perform manually but can be easily adapted to open automated IHC systems or the soon to be released Novodiax Q-STAIN(R) X System. This means that most any ihcDirect(R) assay can fit neatly into most any hospital lab or clinic setting. Additional ihcDirect(R) assays planned for the near future include: CDX2, E-Cadherin, p120 and WT1.
Please contact us at www.novodiax.com to learn more!
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(R) platform allowing rapid determination of tissue during intraoperative procedures and is exploring applications for cytology and companion diagnostics. For further information visit our website at www.novodiax.com.
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