December 28, 2020 (Viz Release) – – Novodiax has followed-up the recent launch of its rapid p40 antibody for immunohistochemistry (IHC) testing with two new rapid ihcDirect(R) antibody assays: TTF1 and Napsin A for in vitro diagnostic (IVD) use. TTF1 is a transcription factor protein primarily expressed in lung and thyroid glands with critical functions in differentiation of these organs and Napsin A is an enzyme involved in surfactant protein maturation and is expressed in type II pneumocytes and in the majority of lung adenocarcinomas. When these antibodies are paired with antibodies such as p40, can be highly sensitive and specific1 for distinguishing different forms of lung cancer.
Novodiax is pioneering rapid IVD histology and rapid cytology testing and working to make it possible for clinicians to impact patient care via releasing very fast IHC tests that have under 20 minutes from excision-to-actionable result turnaround times. Today, ihcDirect(R) assays are being employed by many physicians who want to more efficiently manage patient workflows and the corresponding workloads in their institutions. TTF1, Napsin A and p40 further cement the company’s franchise in this 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(R) assays may also be used to support clinical decisions such as being able to help justify removal of fewer lymph nodes during surgery and/or the reducing the frequency of required follow-up surgeries due to incomplete excision.
The ihcDirect(R) TTF1 and Napsin A assays utilize the proprietary Novodiax polymerized HRP chemistry which helps to improve staining sensitivity and increases test speed.
ihcDirect(R) TTF1 is a polyHRP conjugated rabbit monoclonal antibody (clone R373). TTF1 is a transcription factor with a 38 kDa homeodomain region that is primarily expressed in lung and thyroid glands with critical functions in differentiation of these organs. It is also expressed in the CNS regions differentiated from the diencephalic region. TTF1 is commonly used to distinguish primary non-squamous lung carcinoma from metastatic carcinoma. Other applications of TTF1 include differentiating between lung adenocarcinoma and squamous cell carcinoma. Additionally, it distinguishes subependymal giant cell astrocytoma from gemistocytic astrocytoma and ganglioglioma which demonstrate similar histopathological features.
ihcDirect(R) Napsin A (Novel aspartic protease in the pepsin family) is an enzyme involved in surfactant protein maturation and is expressed in type II pneumocytes and in the majority of lung adenocarcinomas. Napsin A is helpful for confirming lung origin in carcinomas of unknown primary and for distinguishing lung adenocarcinomas from other pulmonary neoplasms, such as squamous cell carcinoma and mesothelioma. The combined use of Napsin A and thyroid transcription factor-1 (TTF-1) improve the sensitivity and specificity for identification of molecular markers of pulmonary adenocarcinoma.
ihcDirect(R) TTF1, Napsin A, and p40 assays are all ready-to-use and perform equally well in FFPE histology as well as frozen tissue 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. This means that ihcDirect(R) TTF1, Napsin A, and p40 can fit neatly into most any hospital lab or clinic setting. Additional assays planned for the near future include: Chromogranin A, Galectin-3, PTH, TPO and TROP2.
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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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