There is a movement on Greenville’s medical horizon – a rapidly growing emphasis on the personalization of treatment. And some of Greenville’s top innovative minds are taking the challenge down to a new level – a molecular level to be exact. New technologies are being developed that strip horrible ailments such as cancer, infectious diseases, even hereditary illnesses down to their genetic core and then use that DNA material to derive diagnostic tests and treatments that are working to change everything we thought we knew about the diseases. They are discovering methods for earlier diagnosis, more accurate treatments, and more targeted drug therapies. And it all boils down to this – better diagnostic information means better outcomes for sick patients. Companies like Lab21, along with research, academic and healthcare organizations, are leading the charge and bringing Greenville to the forefront of innovative medical care.
Lab21 in America
Lab21’s story in America begins in 2006 when Michael Bolick, CEO of Selah Technologies, LLC licensed molecular imaging nanotechnology from Clemson University. Selah developed this technology, known now as Selah Dots®, into a tool to make cancer “light up.” Bolick’s team focused the Selah business plan to help surgeons more clearly distinguish margins in breast conservation surgery for breast cancer patients. To realize this goal, Selah engaged a collaborative network of folks from Clemson University, University of South Carolina (USC), Medical University of South Carolina (MUSC) and Oak Ridge National Lab. Bolick received investment support from South Carolina Research Authority (SCRA), SC Launch, and angel investors, including angels from the Upstate Carolina Angel Network. In May 2009, Bolick was introduced to Graham Mullis, the CEO of Lab21, by Nexus Medical Partners, one of the most active venture capital firms in South Carolina. Lab21, a rapidly growing healthcare diagnostics business based in the United Kingdom, provides state-of-the-art molecular diagnostic products and services in personalized medicine to a wide range of healthcare organizations, clinical laboratories and pharmaceutical companies worldwide. By the end of 2009, Selah was acquired by Lab21 as a launching pad for the company in the U.S. and the Selah Dots® technology was integrated into Lab21’s product development effort to facilitate the creation of new testing kits to revolutionize early screening and disease detection. Bolick, now president of Lab21, Inc., says, “Lab21 is a vertically integrated diagnostics firm made up of two distinct divisions: Products and Services. In our Services Division, we license promising technology, clinically validate it in the form of a Lab Developed Test (LDT) and then offer it as a service from our CLIA registered laboratory. Often, market pressures will demand that these LDTs be converted to a product form which can be used in labs around the world. Our Products Division can respond by translating the LDT into kit form, filing for regulatory approval and then selling and distributing the kit through our network into more than 120 countries worldwide. Of course, we collaborate with other parties as makes sense along the way.”
Becton Dickinson Collaboration
As a case example, in August 2011, Becton Dickinson Diagnostics, a segment of Becton Dickinson, joined forces with Lab21 to develop a cutting-edge molecular diagnostic assay to detect the presence of the deadly Aspergillus fungus via the fully automated BD MAX Molecular Testing System. Aspergillus is a leading cause of infectious death in people with compromised immune systems, with an estimated 10 million people affected worldwide annually. While mortality rates associated with this fungal infection have been estimated at 90 percent, studies have shown that diagnosis and intervention treatment within a 10 day timeframe can dramatically reduce this number to 40 percent. The statistics speak for themselves and point to an obvious need for more rapid and efficient testing measures – that’s where BD Max comes in. The real-time PCR-based test can detect the presence of Aspergillus fungus in the infected person’s blood with greater accuracy than that of current culturing techniques. The new diagnostic test offers faster and more accurate screening measures, arming physicians with the necessary knowledge to make a definitive diagnosis and craft a treatment plan in record time – an improvement that will equate to lives saved.
Drivers for Personalized Medicine
Berwyn Clarke, Lab21’s founder and chief scientific officer says “Lack of efficacy and the associated side effects have been the main drivers for personalized medicine and this is one of the fastest growing areas in medicine. It has been known for many years that one-size-fits-all generic medicine is an inefficient approach to patient management, but the tools have not been readily available to do anything about it. Recently, this situation has changed radically, particularly in the areas of virology and oncology.”
“In virology, many of the foundation stones of personalized medicines were laid down with the recognition that viruses can respond to drugs by mutating their replicative enzymes, so that they become resistant to the therapy. Consequently an HIV patient (for example) that is treated with a specific drug for 6 months may no longer be responsive to that drug, and a new drug needs to be introduced. Techniques of molecular genotyping of the virus have therefore been developed to routinely monitor patients for the appearance of these mutations, so that the drugs can be changed as soon as the mutations appear.”
As one example of such a technique, in July, Lab21 launched an HIV-1 Tropism by Genotype service for Proviral DNA, which identifies the probable co-receptor used by a patient’s HIV-1 virus, enabling patients to be prescribed the appropriate co-receptor antagonist therapy.
Clarke continues, “In oncology, the classic example has been the introduction of herceptin as a therapy for breast cancer but only in patients whose tumors possess the Her-2 biomarker on their surfaces as an indication that the drug target is actually present, and that the tumor is likely to respond to the therapy. More recently, other oncology drugs have followed similar routes as a result of observations that in clinical trials only specific cohorts of patients have responded to particular drugs.”
“The consequence of these findings has been that these drugs have been approved for prescription only to those patients whose tumors have been genotyped to analyze the nature of their targets. The new concept of companion diagnostics has arisen since these drugs require the companion assay to be available commercially at the same time as the drug is licensed. This a major step forward in personalized medicine, because it now means that patients are more frequently treated with a drug that will actually work for them, and if they are not suitable for that therapeutic then an alternative treatment can be used. The availability of the tools to identify and profile these tumors is a complete shift in medical practice that has enormous implications throughout healthcare.”
Game Changing Diagnostic Tools
Lab21 is marshaling these advanced diagnostic tools to provide pharmaceutical companies with information to help identify clinical trial patients who are most likely to gain therapeutic benefit from a given drug. By introducing such patient stratification into trials, these companies are able to reduce the numbers of patients required, the speed of the trial (usually) and importantly the overall cost of the trial. Bolick says, “The FDA is now issuing guidance that in the future, where possible, new therapeutics will be required to have associated companion diagnostics biomarker data available as part of the drug submission package. This means that clinical diagnostics are beginning to adopt a far more important role in medicine.”
When the Institute for Translational Oncology Research (ITOR) of the Greenville Hospital System University Medical Center (GHS) was launched in 2010, Lab21 initiated a collaborative agreement to provide molecular diagnostic support services for new drug development and personalized patient care initiatives within the Institute.
When ITOR announced this summer the creation of its Innovation Zone, a unique high-tech laboratory, Lab21 was one of the first private companies to engage, strategically moving its Selah Dots® product development effort into the space. Bolick says, “We see significant advantage in being co-located in a translational environment with others dedicated to furthering medical diagnostic and treatment technology. There are great synergies which come from working together in such an environment, especially given the close proximity to a top notch biorepository tissue bank.”
Bolick concludes, “We are thankful for the strong relationship forged with GHS and ITOR and the opportunity to be a part of the rising tide in a cutting-edge cancer research atmosphere. We also appreciate the strong rapport and collaboration shared with other hospital systems and research organizations throughout the area, including Self Regional, Spartanburg Regional, AnMed Health System and Bon Secours St. Francis Health System. We intend to partner with these folks as a first step towards establishing Lab21 as a national brand of excellence and innovation. We are thrilled that we have the opportunity to launch this with the U.S. headquarters right here in beautiful Greenville, South Carolina.”