Harvard

The portable device runs an isothermal amplification assay to detect genetic material from strains of tuberculosis in resource limited areas.  

One firm, Exosome Diagnostics, is working to streamline payor coverage for a commercial test, and researchers are simultaneously developing promising ways to isolate exosomes.

The similar analytic performance of LDTs and FDA-approved tests informs the ongoing debate about the regulation of in vitro testing.

The assay employs nanoplasmonics and protein-signal multiplexing in taking aim at early clinical detection of pancreatic ductal adenocarcinoma.  

Dubbed "Sherlock," the new technology has demonstrated potential in detecting viruses and bacteria as well as human SNPs and mutations in cell-free DNA.

They have also developed an exosome-based test for high volume laboratory applications that was recently licensed by Exosome Diagnostics.

The company is preparing a blood-based test for early-stage pancreatic cancer that it hopes to have on the market by 2019.