ihcDirect(R) SOX10, first of 5 new IVD IHC assays for Mohs dermatology use

Hayward, CA (Viz Release) August 3, 2020 - - Novodiax Inc. is excited to announce the release of a truly RAPID 12-minute ihcDirect SOX10 assay for in vitro diagnostic (IVD) use. Novodiax is driven to become "The" leader of intra-procedural immunohistochemistry (IHC) testing.  Now, with the release of this SOX10 assay, an important milestone in melanoma testing can be achieved. According to Jianfu Wang, PhD, CEO of Novodiax, "we've been working for years to perfect a truly rapid SOX10 assay. In making this breakthrough for SOX10 and the use of the new product ihc Enhancer, we are now also poised to release dozens of relevant antibody assays that previously couldn't achieve our stringent requirements for speed and functionality in fresh frozen tissues." In addition to SOX10, Novodiax is preparing to release 4 additional assays in the next month: PRAME, p40, EpCAM, and Desmin.

ihcDirect(R) SOX10, first of 5 new IVD IHC assays for Mohs dermatology use
SOX10 stain in frozen skin tissue

The ihcDirect SOX10 assay requires no special handling such as heat pretreatment or antigen retrieval of the tissue. The assays is truly convenient to use and is the fastest SOX10 IHC test on the market. This means that the assay will fit neatly into current dermatology practices.  Novodiax oncology assays can help drive efficiencies within medical institutions by providing rapid turnaround of histology results on frozen or formalin-fixed paraffin-embedded (FFPE) tissues. Rapid histology tests improve patient care by providing added sensitivity and specificity over H&E tests. Greatly reduced histology test turnaround times and improved workflows may translate into better patient care by helping physicians make more informed decisions, reducing surgeon wait times for vital results, potentially reduce the required volume of tissue extractions needed for a procedure and/or help to eliminate the need for subsequent follow up visits and surgeries.

ihcDirect(R) SOX10 Ab is intended for in vitro diagnostic (IVD) use. ihcDirect SOX10 is a polyHRP conjugated anti-human rabbit monoclonal antibody (Clone R1008) IHC reagent for use on frozen and FFPE. SOX10 is a transcription factor known to be crucial in the specification of the neural crest and maintenance of Schwann cells and melanocytes. It is expressed in nuclei of melanocytes, peripheral nerve sheath cells, and breast myoepithelial cells. Positive nuclear staining for SOX10 is seen in breast basal-like, unclassified triple negative, and metaplastic carcinoma. SOX10 also shows an increased specificity for soft tissue tumors of neural crest origin compared with S100. SOX10 along with other markers like MITF1 may be useful in differentiating melanoma in situ from actinic keratosis with melanocytic hyperplasia. Test results for all ihcDirect products should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information, and proper controls.

Novodiax's patented polyHRP technology is simple to use because the test procedures are rapid and generally require fewer steps to complete. The polymer provides added assay sensitivity which can help improve performance under a microscope or shorten incubation times when compared to traditional IHC test methods. This ready-to-use antibody is conveniently packaged in two different configurations, ihcDirect SOX10 antibody with ihc Enhancer and antibody only in 5mL, 2x5mL, 15mL and 2x15mL sizes. This assay and the other 4 future ihcDirect assays mentioned above are expected to be available outside of the US in September, 2020.

About Novodiax:

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 cytology and companion diagnostics. For further information visit our website at www.novodiax.com.

For inquiries please contact:
Novodiax, Inc.
3517 Breakwater Ave
Hayward, CA 94545, USA
Toll Free: +1 (888) 439-2716
Phone: +1 (510) 342-3043