Two new rapid ihcDirect(R) IVD assays, CK19 and CK20 ready for use from Novodiax

Hayward, CA (Viz Release) July 21, 2020 - - Novodiax Inc. is excited to announce the release of two new rapid ihcDirect reagent tests: CK19 and CK20. Novodiax is driven to be the leader of intra-procedural immunohistochemistry (IHC) testing and with the release of these new ihcDirect staining kits for in vitro diagnostic (IVD) use, the company continues to demonstrate its commitment to rapid histology testing. According to Jianfu Wang, PhD, CEO of Novodiax, "These new products are positioned to support rapid IHC testing on frozen tissues such as breast, lung, thyroid and kidney," to provide timely and relevant markers for pathologists.

Two new rapid ihcDirect(R) IVD assays, CK19 and CK20 ready for use from Novodiax

Novodiax oncology assays can help drive efficiencies within medical institutions by providing fast 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 may also translate into better patient care from reduced surgeon waiting times for vital results. Novodiax is pleased to release ihcDirect CK19 and CK20. We are continuing to work to provide convenient, timely and relevant markers that can not only help speed clinical decision-making but help to eliminate the need for subsequent follow up visits and surgeries.

- ihcDirect CK19 Ab is a polyHRP conjugated antibody. CK19 is often coexpressed with CK7 and present in both simple and complex epithelium. Staining for CK19 can be seen in both normal and malignant tissues, such as, breast cancer, endometrial cancer, hepatoid adenocarcinoma, renal carcinoma, urothelial carcinoma, lung cancer, Paget’s disease, pancreatic ductal carcinoma, squamous cell carcinoma and thyroid papillary carcinoma. The antibody may also be useful with other markers as part of thyroid cancer panels, to confirm a diagnosis of thyroid carcinoma from follicular adenoma and Grave's disease.

- The ihcDirect CK20 Ab is an important epithelial marker. Because there are a limited number of cancers where CK20 stains positively, the marker is often performed with other markers such as CK7 to help differentiate several types of cancers. CK20 has been used in colon cancer, gastric cancer, hepatocellular cancer, ovarian cancer, and prostate cancers. When used in combination with CK7, the assays may help differentiate neoplasms such as carcinomas of the bile duct, lung-mucinous bronchioloalveolar, pancreas and upper GI tract, carcinomas of bile duct, breast, endocervical and endometrial adenocarcinoma, esophagus, lung, salivary, as well as mesothelioma.

These products are intended for in vitro diagnostic (IVD) use.

Test results for these 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 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. These ready-to-use antibodies are conveniently packaged with color-matched lids available in 5mL, 10mL, 15mL and 30mL sizes.

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 companion diagnostics. For further information visit our website at

For inquiries please contact:

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