iMDx Stock Rebounds After-Hours As Study Shows Transplant Test Works As Well As Market Standard

Shares of Insight Molecular Diagnostics jumped 5.7% in after-hours trading on Monday following a study presentation that shows comparable performance of its dd-cfDNA test in monitoring kidney transplant rejection. 

The stock fell 13.7% on Monday’s regular session to close at $3.66.

The company said that GraftAssureIQ, a digital PCR-based diagnostic kit for transplant management, generated similar measures of donor-derived cell-free DNA (dd-cfDNA) in 96 transplant patients to an existing NGS-based test.

The biomarker is used to assess the risk of transplant rejection.

The study was conducted by the University Hospital Heidelberg in Germany and represents the first direct comparison of two commercially available dd-cfDNA test kits based on single nucleotide polymorphisms (SNPs). 

According to Chief Science Officer Ekkehard Schuetz, the findings show that both digital PCR and NGS platforms provide consistent dd-cfDNA results — referring to donor-derived cell-free DNA, a key biomarker released into the bloodstream when a transplanted organ is under immune attack. 

He added that digital PCR showed improved analytical sensitivity, suggesting it may be more effective in detecting low concentrations of dd-cfDNA during early stages of rejection.

CEO Josh Riggs added that the results bolster confidence ahead of the company’s planned commercial launch of its clinical-grade test, GraftAssureDx, which remains under development.

Extended data from the study will be presented at the upcoming European Society of Organ Transplantation (ESOT) Congress in London. 

The company is targeting the estimated $1 billion transplant rejection testing market and is advancing multiple products under its GraftAssure brand.

Shares of Insight Molecular Diagnostics are up 15.8% year-to-date, outperforming the broader market.

In comparison, the Nasdaq is up 12%, while the Dow and S&P 500 have risen 0.5% and 2.7%, respectively, over the same period.

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