Massachusetts Patent of the Month – September 2022

Monitoring genetic changes in cancer cells by analyzing their nucleic acid profile is important in the treatment of the disease. Typically, these analyses are performed on samples from surgically removed tumor tissue or from tissue obtained by biopsy, which are both invasive procedures that can lead to discomfort for the patient. The ability to perform these tests using bodily fluids would be desirable, as genetic changes can be monitored in tissue cells that are not easily accessible, such as in ovarian or brain cancer patients. However, bodily fluids contain a mix of biological materials, making it difficult to identify, extract, and analyze nucleic acid profiles. 

Exosome Diagnostics, Inc. aims to implement practical solutions in clinical laboratories to monitor genetic changes using samples obtained from bodily fluids. Exceeding industry standards, they have developed a method to analyze biological samples obtained from urine, blood, serum, lymph fluid, saliva, breast milk, and other bodily fluids.  

Their method involves obtaining a biological sample from the above fluids. The sample undergoes a pre-processing step which subjects the sample to centrifugation or gel permeation chromatography to separate the nucleic-acid containing materials from the rest of the sample. An enhancement step is then completed, which removes factors that prevent high quality nucleic acids from being extracted. This involves adding enzymes or reducing agents to the sample. Lastly, the nucleic acids are extracted using centrifugation or chemical extraction processes. This sequence of steps enables DNA and RNA to be extracted from bodily fluids, providing a quick, effective, and non-invasive sampling option to patients.

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