There is an urgent unmet need for simplified and improved blood testing systems that can be utilized outside of centralized clinical settings. Blood cancers are a major health problem in the United States, representing over 10% of all new cancers. Acute myeloid leukemia (AML) is a particularly fast-evolving form of cancer with low rates of survival. Follow initial therapy treatments, AML patients must regularly undergo blood testing to detect against recurrence of the disease. However, existing blood testing paradigms are problematic in that a patient must have their blood drawn by a trained phlebotomist and then wait to receive results from a testing facility. Any delays or lack of compliance in this regular recurrence testing can lead to the development of life threatening symptoms. At Tasso, Inc., we will develop a novel blood-testing platform, the HemoLink-MD, which will allow for self-administered patient blood testing at home and will provide a direct fluorescence readout of nucleic acid levels with minimal user interaction. This blood-testing platform will utilize our existing HemoLink blood collection device and will provide immediate benefit for patients diagnosed with AML. The core technologies developed in this work, novel peptide nucleic acid (PNA) diagnostic techniques and integration strategies for our blood collection devices, will have broad utility towards the development of alternate nucleic acid and protein diagnostic platforms. Tasso, Inc. is uniquely positioned to execute this proposed work due to (1) collaboration with the laboratory of Dr. Daniel Appella at the NIH, a pioneering group in the development of PNA diagnostics, and (2) extensive expertise in the development of blood collection devices and fluidic platforms. Overall, our work will improve the quality of life for patients that require regular blood testing by simplifying the testing process and allowing for faster and improved monitoring of critical biomarkers. The proposal consists of two aims. First, a novel nucleic acid detection assay will be developed using PNA binding chemistries and a fluorophore-quencher fluorescent readout. Secondly, this PNA-based assay will be incorporated into an enclosed cartridge that will be integrated directly into our HemoLink blood collection device. We will evaluate the performance of our entire testing platform using whole blood containing our target of interest, allowing us to identify the critical parameters needed to produce an optimized nucleic acid detection platform.
Patients suffering from acute myeloid leukemia (AML) must undergo regular blood testing to detect for residual leukemia cells. However, this frequent monitoring requires the use of phlebotomy and blood testing services over extended periods of time, reducing the quality of life for the patient. Tasso, Inc. is proposing the development of a blood-testing cartridge that will integrate a novel one-step nucleic acid detection assay directly downstream of our HemoLink blood collection device.
