OncoCyte Corp.

Company Overview

OncoCyte Corp. is developing and commercializing liquid biopsy tests for cancer applications with an initial focus on lung cancer.

The company’s focus is on commercializing two tests, DetermaRx and DetermaIO. This focus followed disappointing results, announced in July 2020, for the company’s DetermaDx test. This test did not meet the goal of statistically improving clinical factors being used by physicians today to help with diagnosis of intermediate-risk nodules, especially in the 0.8 to 2.2 cm nodule size range.

DetermaRx is a lung cancer stratification test, and DetermaIO is a research-use-only gene expression test to identify immune checkpoint inhibitor responders.

In September 2019, Oncocyte acquired Razor Genomics, which had developed an early-stage lung cancer risk assessment assay; Oncocyte rebranded this assay as DetermaRx.

DetermaRx is 14-gene assay designed to help physicians stratify patients for treatment, and it answers the question: should I give adjuvant chemotherapy? The test helps identify patients that are likely to benefit from early, post-operative chemotherapy. The test has the potential to help reduce mortality and cost by preventing recurrences and expensive, late-stage treatment. It also helps patients avoid cytotoxic chemotherapy who may not require treatment beyond surgery. The test uses qRT-PCR and runs on the Thermo Fisher QuantStudio system.

DetermaIO helps to identify immunotherapy responders. It helps answer the question: should I give immunotherapy? The assay analyzes the expression of 30 genes on a PCR format.

In April 2020, Oncocyte’s DetermaRx received Local Coverage Determination from Medicare contractor Palmetto.

In January 2020, OncoCyte entered into an agreement to acquire Insight Genetics, including a lung cancer immunotherapy test in development by this firm. The acquisition gave access to Insight Genetics’ existing pharma service infrastructure, including a CLIA-certified and CAP-accredited lab and a menu of single gene test for actionable biomarkers, including two emerging therapeutic targets, RET and NTRK. It also provided entry into several tests that use NGS platforms, including the Insight TNBCtype triple negative breast cancer assay (uses NGS whole exome RNA-Seq data) and several NSCLC tests that use NGS platforms and analyze key cancer targets including ALK, ROS1 and RET fusions, and ALK inhibitor resistance mutations.

Insight Genetics’ immunotherapy assay, Immune Modulation, or IM Score, is a gene expression test run on biopsy tissue and which gives a readout on the state of the immune system. This is helpful to identify patients more likely to respond to anti-PD-1/PD-L1 drugs. This assay has been re-branded as DetermaIO and has allowed OncoCyte to expand its capabilities to provide actionable answers at critical and underserved decision points in the lung cancer treatment spectrum.

In February 2021, Oncocyte announced an agreement to acquire, through a subsidiary, Chronix Biomedical, a privately held molecular diagnostics company specializing in the development of blood tests for applications in cancer treatment and organ transplants. As part of the acquisition, Oncocyte will gain the intellectual property (IP) and technology associated with Chronix’s TheraSure-CNI Monitor, a patented blood-based test designed for immune-therapy monitoring. Additionally, Oncocyte will acquire the IP related to Chronix’s technology for organ transplants.

Financial Highlights (FY 2023)