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Biobusiness Next-Generation Sequencing Will Soon Be Essential to Cancer Care Protocols Jonathan Witonsky The molecular diagnostics market continues to be the fastest growing segment of the overall in vitro diagnostics market. However, the mo- lecular tests that drove the highest growth rates less than five years ago—for example, for hu- man papillomavirus (HPV) testing and methi- cillin-resistant Staphylococcus aureus (MRSA) screening—are beginning to stagnate. To compete in these gradually saturat- ing segments, vendors are forced to further broaden their molecular testing menus while offering competitive costs. The resulting pric- ing pressures further erode margins on what were once incredibly high-margin tests. In or- der to make up for the stabilizing infectious disease molecular diagnostic market, vendors are increasingly focusing their attention to the markets for oncology molecular diagnostics. Global revenues from the sales of oncol- ogy molecular diagnostics are growing at more than 20% and currently account for approximately 10% of the roughly $5 bil- lion molecular diagnostics market. While Jonathan Witonsky is a principal analyst for the life sciences group at Frost & Sullivan. For more information contact Britni Myers (britni.myers@frost.com). revenues from oncology molecular diagnos- tics currently make up less than 5% of to- tal cancer testing revenue, this percentage is likely to reach 10% over the next five years. Molecular diagnostics for breast and colorec- tal cancer are likely to remain the two largest market segments. However, other oncology molecular diagnostics, including those for prostate cancer, lung cancer, bladder cancer, pancreatic cancer, and ovarian cancer, repre- sent significant market growth opportunities. Molecular tests for oncology enable ex- tremely targeted cancer diagnosis as well as early detection through screening programs. Additionally, with highly sensitive and ex- tremely specific protocols, oncology molecu- lar diagnostics support accurate and appro- priate therapy selection. Oncology molecular diagnostics have had the greatest impact on the diagnosis and treatment of breast and colorectal cancer, with multiple tests widely incorporated in clinical practice. More impor- tantly, these novel oncology molecular diag- nostics have reduced mortality due to cancer. Oncology molecular diagnostic tests are reimbursed at very high levels—as much as several thousands of dollars—when com- pared to other in vitro diagnostics. Higher reimbursement is based on value and cost- savings that can be achieved through the pro- BIOMARKET TRENDS NGS On Way to Becoming Critical Dx Platform Advances in technology will allow clinical labs to carry out oncology molecular diagnostic testing in a high-throughput manner. Chitra Tatachar/Fotolia vision of laboratory-developed tests (LDTs). Laboratory-Developed Tests LDTs allow suppliers to skip the lengthy time for U.S. Food and Drug Administra- tion regulatory review and instead oper- ate as a Clinical Laboratory Improvement Amendments (CLIA)-regulated laboratory, performing tests in-house and marketing services to the medical community imme- diately. Moreover, suppliers can avoid Cur- rent Procedural Terminology (CPT) coding and negotiate with each payer to set prices individually, a long and enduring process to get coverage and market to all potential pa- tients and physicians. Finally, the provision of LDTs allows for suppliers to continually support prognostic clinical trials and collect data for payers to examine. The greatest driver of the oncology mo- lecular diagnostics market is the growing de- mand for targeted clinical sequencing panels that necessitate next-generation sequencing technology. While the use of sequencing in clinical applications is at its nascent stage, it is expected to increase as the cost of sequencing further decreases toward the $1,000 genome milestone. The market price per genome for whole genome sequencing is expected to hover around $4,000 for the full year 2012. However, by next year, many of the CLIA- certified diagnostic laboratories that were previously barred from the technology due to its high costs are expected to incorporate next-generation sequencing clinical tests. With next-generation sequencing, labo- ratories will be able to perform very sensi- tive oncology molecular diagnostic testing in an incredibly high-throughput fashion. The rapid evolution of clinical sequencing using next-generation technology will also lead to the very rapid development of many new clinical biomarkers and tests. Although challenges associated with data manage- ment and analytics are likely to remain a hurdle, these laboratories recognize that the incorporation of next-generation sequenc- ing is essential to their cancer care protocols. Next-generation sequencing will ulti- mately become an essential diagnostic plat- form among molecular pathologists. Fit- tingly, technology vendors are aggressively pursuing the market with expectations that as much as half of their next-generation se- quencing related revenues will come from clinical applications by 2015. CORPORATE PROFILE SciLog Continued from page 14 feedback loops and automation. The result is the SciFlex and SciPure product lines, used for GMP liquid handling. The third main area is single-use precali- brated sensors. "The biotech industry has embraced single- use technology. They want closed systems to minimize contamination risk," says Juliette. SciLog offers disposable manifolds with sensors, tubing, connectors, bags, and filters that are gamma irradiated to insure sterility. In fact, the growth of single-use products spurred SciLog's move to larger offices in March, according to Juliette. A key feature of SciLog's product phi- losophy is open architecture, which means customers can use filters, tubing, and other disposables made by various vendors. A number of other manufacturers of hardware and manifolds require customers to buy one type of filter, tubing, or bag. "This doesn't give customers the freedom to choose a source. They are married to one vendor, and if that vendor cannot deliver, production schedules can be upset," Juliette points out, noting that open architecture eliminates supply chain risk and keeps pro- duction on schedule. Flexible open architec- ture design allows for the seamless addition and removal of components, and it offers an adaptable process flow design with plug- and-go operation, she adds. New Products and Old Standbys Juliette emphasizes that SciLog lis- tens closely to its customers to design new products and accessories. The SciLog Weigh Station uses a fluid handling platform that permits customers to fill or empty single-use bags gravimetrically. "Some of our customers indicated that they wanted something more," says Juliette So SciLog developed multiple configurations with slide-in-place accessories, including filter hold- ers, tubing holders, trays, and work platforms. The Weigh Station platform supports multiple hanging bags and can be rolled around to easily move media from one lo- cation to another. When pumps are added, a complete, quantitatively monitored work station for single-use technology becomes available. "It's really caught on because of the versatility, mobility, small footprint, and accessories we added," says Juliette. SciLog's products largely focus on down- stream purification applications. Now a new product line, called MabTech, targets upstream processes. MabTech manages, au- tomates, and documents bioreactor feeding and recirculation tasks. Some applications, like generating high density cell cultures, may take weeks or months, and MabTech performs these long-term tasks with high precision, according to Juliette. "MabTech starts with a client's current cell culture systems, then enhances them. No major reinvestment is required to optimize what you have," she says. Although not new, SciFlex and SciPure products are aggressively priced workhorses, which provide automation and documenta- tion. When paired with SciLog's precalibrat- ed, single-use manifolds, a mobile system with a compact footprint performs tangen- tial flow filtration, normal flow filtration, and perfusions. A touch screen asks the op- erator questions specific to their process, and the answers given by the operator generate a flow path and programs that give complete process documentation for the user. "This is a device for process development and batch transfers," says Schick. A receptionist answers all phone calls and connects callers to a SciLog expert. There are no phone trees to navigate. "We pride ourselves in rapid response times," explains Juliette. 16 | October 1, 2012 | genengnews.com | Genetic Engineering & Biotechnology News At-a-Glance SciLog Location 801 Deming Way Madison, WI 53717 Phone 608-824-0500 Website www.scilog.com Principals co-founder, CEO, and president Juliette Schick, Ph.D. co-founder and chairman Karl Schick, Ph.D. Number of Employees 30 Focus SciLog designs, manufactures, and sells computer-controlled bioprocess- ing instruments and software for biopharmaceutical laboratories.