Low-Cost Diagnostic Tools Allow Widespread Clinical Adoption

Next generation sequencing technologies are creating low-cost diagnostic tools that can enable widespread clinical adoption.

Next-generation DNA sequencing technology provides high throughput, ultra-low cost assays with high sensitivity and specificity for rapid multiplex identification of pathogens, such as methicillin resistant Staphylococcus aureus (MRSA) and human viruses. This multiplexing technology can target many pathogens simultaneously, greatly accelerating accurate diagnosis, from the current 4-10 days by culture, to under 24 hours, at less than a dollar per pathogen.

Low cost multiplexed diagnostic assays offer a solution to current healthcare reimbursement for nucleic acid tests, and can save millions of dollars of unnecessary single pathogen assays.

Harvard University (Cambridge, MA, USA) Prof. George Church will present Pathogenica (Cambridge, MA, USA) at the Next Generation Dx Summit (Washington, DC, USA; August 24-26, 2010) as a study in how next generation technologies such as the company's BioDetection (DxSeq) system are significantly faster and more affordable than current standards, thereby facilitating more widespread adoption by healthcare providers.

Low cost multiplexed diagnostic assays offer a convincing solution to questions over current healthcare reimbursement for nucleic acid tests, and can save millions of dollars of unnecessary single pathogen assays.

Prof. Church will outline Pathogenica's strategy toward Clinical Laboratory Improvement Amendments (CLIA) certification and the US Food and Drug Administration (FDA; Silver Spring, MD, USA)- approved diagnostic panels, present proof-of-concept application of Pathogenica's technology for detection of multiple pathogens in clinical samples, and discuss new approaches to diagnostic monitoring enabled by this low-cost technology.

In addition, he will discuss how the evolution of next generation sequencing technology is significantly enhancing the diagnostic landscape for infectious disease, and will offer a perspective on the need to demonstrate clear clinical benefits to achieve more wide spread adoption by healthcare organizations and clinicians.

Prof. Church cofounded Pathogenica in 2009, together with Dr. Adeyemi Adesokan. The company's mission is to pioneer commercial applications of pathogen sequencing. Next-generation DNA sequencing technology will meet the clinical demand for rapid multiplex identification of pathogens, drug resistance genes, and toxins in patient samples. The high throughput pathogen-detection system will deliver rapid and highly sensitive identification of a wide variety of pathogens from a patient sample.

Related Links:
Harvard University
Pathogenica
US Food and Drug Administartion