Innovative immunodiagnostic assays for the lab market

Jan. 23, 2017
Douglas Kurth President,Binding Site, Inc.


I joined Binding Site in 2012. Prior to Binding Site I worked at Dako and Abbott Diagnostics in various leadership positions. I have been involved in the global IVD market for my entire career.

I attended the University of Rhode Island and earned the degrees of BS in Biology and MS in Microbiology, with a concentration in Molecular Genetics.

I enjoy fishing, hiking, biking, and travel. My wife and I support Compassion International, a child-advocacy ministry that helps children in poverty. We sponsor two children through this organization: Liseth from Ecuador, who is 15, and Rio from Indonesia, who is 17.

If you were explaining Binding Site, Inc., to someone who is not familiar with the organization, how would you characterize its primary areas of expertise? Binding Site is a Special Protein company committed to the research, development, manufacture, and distribution of innovative immunodiagnostic assays for the global laboratory market. With extensive expertise in antibody specificity technology, Binding Site gives clinicians and laboratory staff the tools to significantly improve diagnosis and management of patients across a range of blood cancers and immune system disorders.

What are the major categories of solutions that the company provides for the clinical lab? The major categories include innovative special protein assays (e.g., Freelite, Hevylite, and Ig subclasses), and special protein analyzers. The Freelite assays are sensitive and specific polyclonal antibody tests that measure kappa (Κ) and lambda (λ) free light chains (FLCs) in the serum and urine. Freelite provides rapid and highly sensitive results to aid in the diagnosing and monitoring of monoclonal gammopathies, including multiple myeloma. The Hevylite assays complement Freelite for monitoring multiple myeloma patients.
Binding Site also offers to the clinical lab its latest innovation in special protein testing—the Optilite Special Protein Analyzer. We believe this is the future of special protein testing.

How would you define the term “specialized medical diagnostics,” generally? What are the broad trends in specialized diagnostics today? Specialized medical diagnostics is the expertise, focus, knowledge, and training in a very specific area in medical diagnostics; for example, our focus in special proteins and disease states such as multiple myeloma and immunodeficiency. Specialized diagnostics have become more specific, sensitive, and personalized, and our innovative assays are highly sensitive, enabling clinicians to make more informed decisions about patient care.

Can you give a thumbnail description of the technology behind Binding Site’s antibody assays? Binding Site’s antibody assays are based on highly specific sheep polyclonal antisera that recognize the widest variety of epitopes, allowing accurate sample measurement.

Free light chains (FLCs) found in monoclonal gammopathies are highly polymorphic, showing a wide variation in kappa and lambda epitopes. The polyclonal Freelite assay is able to detect close to 100 percent of cases of light chain multiple myeloma due to its ability to recognize this wide variation. In many of our assays, high analytical sensitivity is achieved using latex-enhanced polyclonal antisera.

Returning to the Hevylite assays: Binding Site recently announced FDA clearance of those assays on the SPAplus and Optilite platforms for monitoring multiple myeloma (MM) patients. How will this product enhance lab efficiency and patient care? The Hevylite assay improves lab efficiency by reducing ambiguity associated with other testing methodologies such as serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE). Efficiency is also improved because Hevylite is an automated, quantitative assay that requires less manual hands-on time than other methods to identify and quantify the monoclonal protein.

Hevylite allows for enhanced clinical decision-making about patient care. For example, measuring IgA monoclonal proteins that co-migrate in the β region is often complex to interpret, making it difficult to monitor disease. Hevylite overcomes the difficult measurement of IgA monoclonal proteins. This improved accuracy in measurement gives physicians data to help clinicians make more informed decisions.

How does the Freelite test identify patients with MM? Can it also be used in the monitoring of response to treatment? Freelite is an automated assay that measures free kappa and free lambda light chains in the serum and urine—not only at elevated, abnormal levels, but also within the normal serum ranges. An abnormal kappa/lambda ratio is a sensitive and specific marker for monoclonal gammopathies.

Freelite is used in both diagnosing MM and monitoring response to treatment. The short half-life of FLCs can allow for earlier indication of response to treatment compared to other traditional methods such as serum protein electrophoresis (SPE).

What are some key features of the Optilite special protein analyzer that make it attractive to clinical labs? The key features of the Optilite include high throughput; the continuous loading and unloading of samples, reagents, and disposable cuvettes; on-board refrigeration of reagents; and optimized assay protocols with wide measuring ranges and large dilution steps, eliminating the need for manual dilutions. The Optilite also uses three different methods of antigen access protection to provide consistently accurate results. These features work in harmony and will optimize the lab’s workflow and provide our customers enhanced efficiency.

What broad industry trends do you see that may affect your company in the future? How are you preparing to address them? Binding Site believes that laboratories will continue to seek ways of being increasingly efficient—doing more with the same or fewer resources.  For this reason, we have focused our development efforts on special protein systems that yield the highest possible efficiency that will positively impact laboratory workflow. Our new Optilite special protein analyzer and optimized protein assays are examples.

We also anticipate that laboratories will play an increasingly important role in communicating the clinical relevance of laboratory results to physicians. Labs are moving to provide additional guidance to enhance the clinicians’ ability to interpret and use test results. Binding Site is working with our customers to create language that can be added to lab reports reinforcing guideline-driven testing algorithms—for example, the use of Freelite along with SPE when screening for multiple myeloma.