After unsuccessful attempts to bring its legacy lung cancer test to market and significant downsizing, Oncocyte Corp. is leaving Orange County.
The oncology diagnostics technology firm in June relocated its corporate headquarters from Irvine to Nashville, Tennessee.
It also rebranded from Oncocyte to Insight Molecular Diagnostics Inc. (iMDx)—the company began trading on the Nasdaq under the new ticker “IMDX” as of June 18.
The company, which has 13 employees, said the name change and out-of-state move reflect its expanded focus beyond oncology, including its strategic push into transplant medicine. Nashville is also home to the company’s CLIA-certified lab and “a growing hub for healthcare innovation,” the company said.
“We believe that iMDx is just getting started in its value-creation journey and that these changes reflect our renewed priorities and focus,” iMDx Chief Financial Officer Andrea James said in a statement.
The company has more than 10,600 square feet of space in Nashville, including its 4,826-square-foot CLIA-approved laboratory, according to the company’s annual report.
Last year, iMDx expanded its Nashville footprint by adding one new office lease and renewing existing leases with MPC Holdings LLC, for about 8,300 square feet of rentable office space.
By relocating to Nashville, often called the healthcare capital of the South, iMDx said the move would bring it closer to core infrastructure and industry talent.
The company also has a research and development lab in Göttingen, Germany, which it obtained through its acquisition of San Jose diagnostic company Chronix Biomedical Inc. in 2021.
IMDx said it expects to maintain its R&D lab in Germany with the relocation.
Moving From Development to Commercialization
IMDx raised $29.1 million in February to drive development and commercialization efforts for its transplant assay.
The in vitro diagnostic (IVD) test kit, rebranded from VitaGraft to GraftAssureDx as part of the company name change, is currently under development for clinical use to help detect signs of transplant rejection.
So far, the company has enrolled three transplant centers as participants for an upcoming clinical trial. It expects to receive Food and Drug Administration clearance for what will be its first clinical use transplant test kit in 2026.
The company also has a version of GraftAssure that was launched last July for research use only. It’s currently used by 10 transplant centers in the U.S., Europe and Southeast Asia.
In May, iMDx reported first quarter revenue of $2.1 million, derived from pharma services performed at its clinical lab in Nashville. The company has yet to generate commercial sales from its testing kits and, as of 2024, counted an accumulated deficit of $350.5 million.
Revenues will help offset business costs as it continues to work on its core transplant and oncology products, according to the company.
“The first quarter was defined by disciplined progress, as our team performed the essential work required to advance from development to commercialization,” management wrote to shareholders in a May 12 update.
IMDx went public in 2016 when it was spun off from another biotechnology company, BioTime Inc., which is now known as Lineage Cell Therapeutics (NYSE: LCTX).
IMDx’s first product was DetermaDX, a noninvasive liquid biopsy test aimed at detecting small masses of tissue in the lungs. In 2020, it discontinued work on DetermaDX due to not meeting clinical endpoint requirements, causing shares to tumble 52% in the days following the announcement.
At press time, shares were down 5.4% to $3.40 and a $86 million market cap.