Invivoscribe PrepQuant: Streamlining Clinical DNA Extraction

The liquid biopsy space continues to grow and heat up - just this week Roche's Foundation Medicine unit announced the acquisition of Minimal Residual Disease (MRD) test developer Saga Diagnostics for just over a half billion dollars.  Numerous MRD and Multi-Cancer Early Detection (MCED) companies continue to spring up, with even more analyte types - first it was cell-free DNA, but now cell-free RNA and exosomes have entered the picture and probably a bunch more.  Extracting DNA from biofluids - mostly plasma, but sometimes urine or something else - is a critical step with many available methods - and many of those are labor intensive or incompletely automated.  As testing volumes scale, there will be a need to reduce the hands-on effort both to keep costs down and consistency up.  Just before AACR, Invivoscribe unveiled a new instrument for cell-free DNA purification and quantification which intends to reduce hands on time significantly over existing methods.

PrepQuant is a benchtop instrument which accepts small disposable cartridges.  Cartridges are pre-filled with reagents.  Anywhere from 1 to 24 cartridges can be used in a run, enabling flexible sample batch sizes.  Initial launch will be cartridges for genomic or cell-free DNA, but cell-free RNA and FFPE reagent cartridges are on the Invivoscribe product roadmap. DNA is DNA - the same DNA can be used for qPCR, digital PCR, or high throughput sequencing.

PrepQuant cartridge

Preparing a batch involves loading the desired number of barcoded cartridges into a rack, peeling back a foil seal, pipetting in the sample, inserting two tips and the elution tube into a separate holder.  Once a batch is launched, the instrument handles the extraction, concentration of DNA, and quantitation - for many existing workflows, quantitation is a separate step requiring further hands-on time by the operator.

PrepQuant loaded with 24 cartridges

Two existing players in this market are the ThermoFisher KingFisher and the QIAGEN EZ2 instruments.  In side-by-side testing, PrepQuant delivers DNA which is equivalent or better than the legacy players on measures such as total DNA, 260/280 ratio (DNA purity), and 260/230.  Critically, the amount of hands-on time is reduced by over a factor of two.   

The instrument was developed through a collaboration between Invivoscribe and Hitachi High-Tech Corporation.  Hitachi may be best known in the genomics community for buying a major stake in electronic DNA mapping company Nabsys, but they have also quietly built a number of clinical systems which are sold under other brands.

Invivoscribe is an interesting company in that they both make products for others to use but also run their own network of clinical testing laboratories.  This hands-on expertise informs their product design and should reduce the risk of creating an instrument that sounds good but doesn't actually solve a key problem.  By simplifying DNA extraction for the growing DNA testing market, PrepQuant would seem likely to achieve product-market fit - though sometimes the marketplace makes fools of prognosticators such as I.