About Novodiax
Novodiax is dedicated to advancing tissue-based diagnostics and immunoassays through innovations that deliver high quality test results with less effort and in much less time than traditional methods. Our signature technology platforms are directed towards anatomical pathology, small reference labs such as dermatopathology, and medical doctor’s offices, e.g. Mohs dermatology surgeons. Each exciting tool builds off of our proprietary polymer-based (pHRP) detection system, the amazing Q-STAIN® X Autostainer, and the new DewaxAR™, our unique antigen retrieval and deparaffinization system.
We have developed a series of immunohistochemistry (IHC) assays based upon the highly sensitive polymer conjugates. These antibody-based reagents are delivered to the market via our branded ihcDirect® and pHRP™ labeled products. Similar corresponding reagent lines are branded for the Q-STAIN X platform and include QSX™ automated reagents and our ihc antibody reagent lines for manual uses.
Soon we will offer a new line of ancillary products such as frioBlock™ and frioFix™ and DewaxAR™ buffers. These products will further enhance the quality of test results to for instance help overcome such common laboratory challenges as IHC peroxidase staining from endogenous peroxidase within tissue specimens. These new product lines may also help to serve as a means of delivering formalin-fixed paraffin-embedded (FFPE) stain intensities via frozen tissue specimens going forward. If users are able to make this transition in the future, this could solve many intransigent laboratory workflow challenges and bring valuable benefits to routine histology testing.
Further, these novel histology products address several unmet needs across a wide range of other applications and markets. Some of these applications include: a) rapid intraoperative testing for surgical pathology such as in breast pathology, b) efficient testing of biopsies in small reference labs using FFPE tissues, c) the novel applications in cytology for biopsies such as fine-needle aspirate (FNA) biopsies and early diagnosis of diseases such as breast, lung, or lymph nodes, and d) the efficient operation of medical clinics like Mohs dermatological doctors offices surgeries.
In the future, we anticipate that rapid frozen tissues or biopsy specimens may prove useful as a means of facilitating the next generation of ultra-sensitive companion diagnostic tests, such as HER2, PDL1 and many others.
Finally, each Novodiax product, whether an antibody reagent or device is designed to operate as simply as possible. In developing each of these products, we’ve carefully considered the hands-on and operational characteristics required for each product by users. We understand the pressures of performing tests under the stresses of a stringent timeline and all of our products reflect this understanding. From the simple use of multi-colored reagent lids to help manual users immediately know what reagent they are utilizing to chromogen reagents that require minimal preparation time, to the highly integrated Q-STAIN X System and its GUI software, we have given much thought to each step in the testing process and considered its impact upon the next step.
It is our fondest wish that you come to experience these products and come to love both the quality of results each product delivers matched with the simplicity that is evidently designed into these products.
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Q-STAIN® X Autostainer
The Q-STAIN X Autostainer is a small system that delivers a lot. The system greatly improves the reproducibility and consistency of IHC testing while performing routine mundane tasks of IHC testing that require labor and tedious hands-on time. This novel system efficiently produces IHC tests while keeping assay test turnaround times to a minimum.
Some benefits of Q-STAIN X include:
- Small size and powerful features make this system a natural fit to most any histology laboratory.
- Q-STAIN X automates a majority of hands-on processes for frozen tissues and other immunohistochemistry testing applications, e.g. FFPE.
- Q-STAIN X QSX reagents minimize hands-on time via integrated barcoded reagent cartridges. This integrated with the Q-STAIN X software helps to speed user hands-on times when programming test runs.
- Chromogen reagents are ready-to-use and require minimal preparation time. These reagents when mixed are stable for 3-7 days depending upon the configuration.
- Novodiax’s proprietary pHRP is integrated into the device and helps the system drive assay sensitivities and/or reduces tests turnaround times.
- Six (6) bulk reagent locations serve a variety of functions, e.g. on-board peroxide specimen pretreatment.
QSX Reagents
QSX Reagents are fully integrated within the Q-STAIN X Autostainer platform. These reagents are barcoded which greatly simplifies the processes required to program the Q-STAIN X instrument. QSX reagents are designed to be similar to the proprietary applications of pHRP described below in the ihcDirect discussion. Every QSX reagent is designed to perform well on frozen tissues, FFPE and may be also used in other applications such as cytology when paired with an appropriate fixative.
ihcDirect®
ihcDirect antibodies are conjugated with a patented polymerized horseradish peroxidase (pHRP) that is revolutionary. This technology directly attaches polymerized HRP molecules onto antibodies to gain function and sensitivity. Each antibody has been screened and developed and optimized to fit a variety of applications, especially frozen tissues and FFPE testing. Direct conjugation of antibodies deliver results by driving assay sensitivity that can help to facilitate the use of certain assays functional performance. This added sensitivity can also be applied to increasing test speeds and the simplification of test protocols by reducing the total numbers of steps.
ihc
Novodiax use the lower case “ihc” to describe our family of reagents for ancillary reagents, e.g. ihc Wash Buffer but are also now used to describe antibody and ancillary reagents that are fitted onto the Q-STAIN X but applied to manual applications or to describe some reagents that may be sold to be placed upon competitive system platforms. A QSX formulated antibody may be labeled as ihc plus the antibody name when it is applied a test performed manually and with the use of ihc Enhancer.
CDx and Services
Novodiax is developing a novel technology that can enable companion diagnostic testing using frozen tissues and/or cytology specimens. Novodiax offers services to pharmaceutical and strategic partner studies and connects in a variety of ways. Our novel technology can enable:
- Early testing to determine the binding profile on cancer tissues in early development stage.
- Applied to tissue cross-reactivity testing in late pre-clinical stages. May include toxicity screening or tissue compatibility. Simply put, there could be advantages to early human testing by directly conjugating the new drug entitiy NDE and testing it on human tissues with IHC.
- Supporting the promotion and release of companion diagnostic tests within the clinical market. Novodiax is developing a novel technology in this space and is open to working with collaborators.
Our Commitment to Quality
The Novodiax Quality Policy is to develop and deliver safe, effective and reliable in vitro diagnostic products through compliance with regulatory requirements, meeting customer needs, and maintaining the effectiveness of the quality management system.