According to the World Health Organization (WHO), tuberculosis (TB) continues to cause significant mortality and morbidity throughout the world, recently surpassing HIV as the single largest killer of all infectious diseases. Standard diagnostic techniques for TB include sputum smear microscopy and microbiological culture confirmation. As a result, diagnosis of TB is both difficult and time-consuming, especially in smear-negative, HIV-infected and pediatric patients. Next-generation tests for TB show promise as faster, more sensitive alternatives to traditional methods.
Sputum, which is the most common specimen type for diagnosing TB, is very challenging to process, particularly for molecular testing methods. Driven by the growing need for robust methods to isolate and purify DNA for molecular detection, the NIH is seeking a simple, cost-effective device to process sputum and stabilize the purified DNA for downstream processing, even in the harsh environmental conditions of TB endemic areas. Also, the purified DNA sample must be suitable for many different downstream detection technologies (i.e. sequencing, isothermal amplification, PCR, etc.) to uncouple the very difficult and costly step of sample processing from the development of the MDx test. This allows the sputum processing and molecular testing to be delinked, with processing done immediately at the point-of-care, or at a centralized facility.
“We have been approached by several different parties, all looking for a similar solution—a simple, rapid, low-cost nucleic acid extraction device that can be used by untrained personnel in the field in developing countries, and produce high-quality, purified nucleic acids that are compatible with several different downstream detection methods. We are excited to work on such an important and valuable solution.” said Rebecca Holmberg, Ph.D., principal investigator and Akonni's project director on the contract.
Previously, Akonni was awarded an NIH grant to accelerate development of its fully-automated, sample-to-answer system for identifying a broader range of multi-drug-resistant strains of TB. In 2014, Akonni, in partnership with Harvard University, was awarded a $29 million NIH grant to further develop its drug-resistant TB diagnostic. Early results from these grant-funded projects have demonstrated promising results, even in non-sputum based samples such as stool, using the Akonni nucleic acid extraction technology and diagnostic platform, thus accelerating the development of Akonni’s next-generation automated multiplexed MDR/XDR-TB diagnostic testing.
“This latest award will help accelerate a key corporate objective of bringing affordable, effective next-generation solutions to low-resource settings. The sample preparation contract complements Akonni’s proprietary TruArray MDR-TB test, which simultaneously interrogates hundreds of genetic markers from a single patient sample, in order to identify common drug-resistant strains of TB," added Michael Reinemann, MPH, director of business development at Akonni. "Our patented microfluidic design and manufacturing procedures enable us to produce the tests at a price point that is affordable for lower-cost settings where TB is prevalent.”
Akonni Biosystems was founded in 2003 and has been issued 17 U.S. and 24 International patents primarily covering sample preparation, microfluidic devices, bioinstrumentation, and integrated systems. Product development has been supported by a series of government grants and contracts from NIH, Centers for Disease Control and Prevention, Department of Energy, Department of Defense, National Institute of Justice, and National Science Foundation. The company significantly advanced the original technology by improving the system’s capabilities from sample preparation to test result. Commercial products in Akonni’s near-term pipeline include rapid sample preparation technologies for nucleic acid extraction and multiplex panel assays for detecting clinically relevant genotypes for pharmacogenomics, human chronic diseases, and genotypes for infectious diseases such as multidrug-resistant tuberculosis (MDR-TB), extensively drug-resistant tuberculosis (XDR-TB), upper respiratory infections, viral encephalitis, and hospital-acquired infections (MRSA). The company is based in Frederick, Md.