Harvard INSPECTR™: Direct-to-Consumer Molecular Diagnostic

A synthetic biology-based molecular diagnostics platform to empower patients and consumers with low-cost, self-diagnostic tests

Molecular diagnostics is the fastest growing segment of the global in vitro diagnostics market. There remains a gap, however, in providing this technology directly to consumers in a format that is as cost effective and as simple to use as a lateral flow immunoassay, like glucose and pregnancy tests. Scientists at the Wyss Institute have developed an innovative synthetic biology-based diagnostics platform to address this need by enabling a low-cost, ‘on-the-go’ nucleic acid detection technology that avoids the expense and instrument requirements of current nucleic acid amplification-based assays. This novel approach combines the specificity, rapid development, and broad applicability of a molecular diagnostic with the low-cost, stability, and direct-to-consumer applicability of lateral flow immunoassays.

The INSPECTR platform (previously known as DROP) uses freeze-dried synthetic gene networks as programmable molecular diagnostic devices. These devices combine cellular components with programmable synthetic biosensors to couple the detection of a target nucleic acid molecule to the production of a detectible reporter protein. Target nucleic acids may be DNA or RNA of an infectious pathogen or host cell, and detection can be programmed to distinguish targets based on a single nucleotide. While any reporter may be encoded, the current reporter system is based on bioluminescence and the output signal is captured with instant film.

The process is operational at room temperature and does not require power or an instrument. The ultra low-cost cell extract and rapidly-deployable sensors encoded in DNA are stabilized by freeze drying for distribution and long-term storage without refrigeration. The diagnostic is activated by simple rehydration with a diagnostic sample such as saliva, blood, or urine.

The INSPECTR platform does not require purification of the target nucleic acid from the crude sample and facilitates development of simple-to-operate systems for the detection of priority agents in consumer and global health applications. This disruptive technology aims to empower patients and consumers with low-cost, self-diagnostic tests, and may further enable the productive use of molecular diagnostics in a broader range applications where cost and portability are key factors.


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