Seegene: Multiplex assays key to companion diagnostics
Seegene, Inc., a South Korea-based company, brings a depth of experience to molecular in vitro diagnostics (IVD) assay development with novel technologies designed to identify single and multiple analytes with high sensitivity and specificity. Founded in 2000, the company’s reputation for innovation is built upon a wide array of diagnostic tests that are today used for screening and diagnosis worldwide.
David L. Dolinger, VP, Head of Business Development Seegene, Inc.
Dr David Dolinger, Head of Business Development for Seegene, explained, “Our current assay menu spans from detection of the causative agents such as respiratory diseases, sexually transmitted diseases, gastroenteritis and cervical cancer, to screening for sexually transmitted diseases, Hepatitis virus A, B and C and multidrug resistance in Mycobacterium tuberculosis.” More than 480 internationally published papers underscore the strength of the Seegene’s technologies in pathogen identification, such as the MagicPlex™ Sepsis Test that is capable of detecting and distinguishing 90 sepsis pathogens and 3 antibiotic resistance genes in a simple two-step assay.
“Seegene’s molecular diagnostic kits are compatible with a wide range of instrumentation,” said Dolinger, “providing flexibility for customized development for partners considering diagnostic capabilities for companion diagnostics.”
Molecular IVDs offer many advantages in diagnosing and guiding the treatment of complex disease such as diabetes, cardiovascular and autoimmune diseases, but nowhere is the potential for enhanced treatment determination of the individual patient more immediately demonstrated than in cancer. Treatment and prognosis for breast cancer has been revolutionized by the introduction of molecular diagnostics, “yet the single-target approach is time- and tissue-consuming, and leaves at a minimum 25% of all breast cancer patients in the dark as to the best therapeutic treatment available,” remarked Dolinger. “With the shifting paradigm toward personalized medicine challenging the pharmaceutical industry, Seegene’s technology platforms are ideally suited to provide diagnostic capabilities through simultaneous determination of multiple analytes from limited patient samples, enhancing the safety and efficacy of new and existing cancer treatments by identifying those patients who will truly benefit from the new cancer therapeutics,” he added.
The advantage to the patient is obvious, but pharmaceutical partners will also benefit from defined patient populations for clinical trials. “Ultimately, the simultaneous profiling of these genetic markers from a single sample will produce a picture of the patient’s specific form or stage of the cancer, as well as factors predicting malignancy, metastatic risk and drug responsiveness. We look forward to partnering with the pharmaceutical industry to use our multiplex technology to develop effective diagnostic and therapeutic combinations in the co-development of effective cancer treatments, as well as assisting the medical community in personalized therapeutic options, instead of the ‘one-size-fits-all’ treatment approach,” Dolinger said.
“One of the first steps in the development of effective diagnostics is discovering true surrogate markers for diseases. Toward this end, Seegene has formed an alliance with Samsung Medical Research Center (SMRC) in Seoul to search for predictive markers in several refractory cancers, followed by development of a multiplex assay based on a subset of these predictive markers.
“The medical community has come to understand the complexity underlying ‘cancer,’ with specific molecular profiles defining malignancy and responsiveness to various drug therapies. The collaboration with SMRC Seoul will provide Seegene with access to invaluable clinically-relevant tissue samples, allowing identification and validation of multiple genetic markers to differentiate and classify various cancers,” said Dolinger.
New areas for partnerships
However, there’s still a lot of work that needs to be done in order to go from validated molecular markers to a validated multiplex molecular assay. While the regulatory community recognizes the value of surrogate biomarkers defining therapeutic efficacy and outcome, the challenges of developing assays that are clinically validated, consistently reproducible and that meet regulatory agency standards are still a substantial hurdle. This is particularly true for the development of multiplex IVDs. “The pharmaceutical industry as well as regulatory agencies should demand the same level of rigorous clinical validation and manufacturing standard for the companion diagnostic as is expected of the therapeutic,” said Dolinger, adding that, “at Seegene, we believe in working closely with our partners from the beginning, to bring our high quality standards to the development of predictive and validated assays.”
To this point, partnering for Seegene has focused on developing strategic alliances with instrumentation companies and commercialization partners for its ever-growing menu of molecular diagnostic assays.
As it prepares for a submission to the US Food and Drug Administration for clearance of a number of panel based assays, Seegene is in intensive discussions with potential lab instrument partners. There is a level of risk for both parties in the partnership as the clinical trials represent a new level of review for the FDA.
A third area for partnering at Seegene is to respond to an unmet need in developing regions for screening disease.
“We have tests available today that can say whether a person is infected with a given pathogen, and then provide that patient’s resistance profile to give guidance on how to treat the patient,” said Dolinger.
“There is a need for cost-containment, of course, but also for testing that requires an ease of use with a low level of training so that people are required only to add the sample,” said Dolinger.
Good co-development starts with genomics
Returning further upstream toward the vision of co-developing companion diagnostics, Dolinger said, “Currently pharmaceutical companies understand companion diagnostics as a way of salvaging an existing drug, rather than true co-development of a new drug entity.” Seegene is seeking a partner who is “ready for a true marriage of diagnostics with drug discovery, a parallel path forward,” he said.
“We can start working with a pharma discovery group today if they have a new chemical entity. We can help with whatever ‘-omics’ the team requires,” said Dolinger.
His preference, however, is to start with genomics.
“If we can get the process back to genetics, then we can start forward in the most efficient way for development, truly starting from the beginning,” he said. “This way we will be able to identify the diagnostic assays required, as well as the targets to be hit from a pharmaceutical standpoint. We can ferret out even more surrogates to be measured, which will not only stratify patients but also indicate the efficacy of treatment.
“This path will both reduce development risk and increase the success rate for new drugs reaching the market. Needless to say, this approach helps to bring the patient to the fore in drug development, right where they should be,” he concluded.
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