ihcDirect(R) PRAME Rapid IHC test ready for use

Hayward, CA (Viz Release) October 12, 2020 – – Novodiax Inc. is very excited to announce the release of our rapid ihcDirect PRAME (Preferentially expressed Antigen in Melanoma) assay for in vitro diagnostic (IVD) immunoassay test. PRAME is an important new marker that has recently demonstrated utility for melanoma and cancers like childhood acute myeloid leukemia.

According to Jianfu Wang, PhD, Novodiax CEO, “our company continues to drive development of novel rapid histology assays especially for Mohs and dermatology applications. Like our SOX10, our ihcDirect PRAME assay requires just 12 minutes to complete on frozen tissue sections. When combined with H&E tests and our other Mart-1 and SOX10 these tests can better support physicians making important decisions about surgical margins on frozen tissue sections for melanoma.” The ihcDirect PRAME assay utilizes the proprietary Novodiax polymerized HRP chemistry which helps to improve sensitivity and increase test speed.

Novodiax Inc. rapid ihcDirect PRAME (Preferentially expressed Antigen in Melanoma) assay for in vitro diagnostic (IVD)

ihcDirect PRAME in frozen skin tissue section

ihcDirect PRAME is a polymerized horseradish peroxidase (pHRP) conjugated rabbit monoclonal antibody (clone R1009). PRAME is predominantly expressed in human melanomas and recognized by cytolytic T lymphocytes. The antibody may also have a role in acute leukemias and in preventing the growth or metastasis of breast cancer cells. A loss of PRAME may also promote the growth and invasion of breast cancer cells.

The ihcDirect PRAME assay needs no special handling such as heat-induced epitope retrieval (HIER) pretreatment or antigen retrieval of the tissue prior to running frozen tissue sections. This assay is very convenient manually but can be easily adapted to open automated IHC platforms. This means that this new test can fit neatly into dermatology practices, hospitals or clinics.

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 can help improve patient care in a number of ways:

– By providing added sensitivity and specificity over H&E tests.
– By improving practitioner and patient workflows via vastly shortened histology test turnaround times.
– Improved workflows help physicians to make earlier and more informed decisions, reducing surgeon waiting times for vital results.
– Better decisions may translate into preservation of vital tissues, e.g. on face during Mohs procedure so fewer tissues are extracted and the use of these antibodies may also help to eliminate the need for subsequent follow up visits and surgeries.

This ready-to-use antibody is conveniently packaged in two packing options, ihcDirect PRAME antibody with ihc Enhancer for use with frozen tissues and the PRAME antibody only for FFPE tissue use.

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