Targeted Cancer Testing.
Throughout Treatment.

Check4® is being developed to detect mutations associated with treatment response and resistance, beginning with EGFR and KRAS in non-small cell lung cancer (NSCLC).

The platform is intended to complement broader genomic testing by making focused, repeated mutation testing more practical in clinical laboratories. Future panels are planned for additional precision oncology gene targets, gene fusions, and other molecular biomarkers.

Check4® uses semiconductor sensors with DNA probes to detect specific genetic sequences, including single point mutations. Target binding produces electrical signals for software analysis. Multiple sensors test each target, providing repeated measurements within a single cartridge.

IdentifySensors Biologics’ proprietary, scalable graphene fabrication process is vertically integrated, with in-house control from material formulation through sensor production and quality testing.

Check4® uses low-cost, reusable hardware that requires no calibration. Hardware would be supplied at cost, with disposable cartridges and software analysis charged per test. This model aims to lower upfront costs and make repeat testing more affordable.

More frequent testing would build richer datasets on genes relevant to treatment response and resistance. Planned AI tools would help interpret this molecular data. With further development and validation, they could also help predict how tumors respond to different therapies. Results are intended to integrate with laboratory and clinical systems.

Cancer can evolve during treatment, making therapies that initially worked less effective. In a Japanese study, approximately 62% of patients with EGFR-mutated advanced lung cancer developed acquired resistance to first- or second-generation EGFR-targeted therapies during follow-up. The findings appeared in Scientific Reports, a Nature Portfolio journal.

Cost, complexity, and long turnaround times can limit repeated molecular testing.

Check4® aims to make frequent testing of selected cancer mutations practical and affordable. This could build richer, more robust datasets over time, helping clinicians assess treatment response and resistance alongside imaging and broader genomic testing.

Check4® uses DNA probes to recognize selected cancer mutations, including changes in a single DNA base. When matching DNA binds to a probe, a process called hybridization, it changes the sensor’s electrical response.

Software analyzes these signals across multiple sensors to determine whether each selected mutation is detected. This electronic approach requires no amplification, enzymes, fluorescent labels, or sequencing.

Check4® is being developed for a four-step workflow that aligns with existing laboratory capabilities:

1. Prepare the sample

Simple plasma preparation includes DNA denaturation, separating DNA into single strands for binding to sensor probes.

 2. Load the cartridge

A multichannel pipette transfers the prepared sample into a disposable cartridge containing sensors for selected cancer mutations.

3. Measure the signals

A reusable reader measures the sensors’ electrical responses in approximately five minutes.

4. Review the results

Software analyzes sensor measurements and test controls to report whether each selected mutation is detected.