AccuStem Sciences, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsAccustem Sciences Inc. is a clinical-stage diagnostics company developing genomic tests for lung nodule classification and breast cancer prognosis, with no commercial products or revenue to date.
What they do
Accustem Sciences is developing two proprietary genomic tests: MSC, a 24-microRNA assay to determine if lung nodules are benign or malignant, and StemPrintER, a 20-gene assay to predict distant recurrence risk in luminal breast cancer. The company plans to launch these as laboratory-developed tests (LDTs) through a CLIA-certified lab partner, EmeritusDx, and has not yet generated any revenue. It operates as one segment with headquarters in New York, NY and London, UK.
Revenue drivers
- MSC (MicroRNA Signature Classifier) — Potential revenue from commercializing a lung nodule test; market opportunity estimated at over $6.3 billion annually in the US, but no sales yet.
- StemPrintER — Potential revenue from a breast cancer prognostic test; no sales yet, but validated in over 3,000 patients including the TransATAC study.
- Ancillary commodity testing — Planned hereditary and somatic mutation testing to augment proprietary assays; no revenue or launch details provided.
Recent performance
For the year ended December 31, 2025, Accustem reported a net loss of $1,756,096, compared to a net loss of $1,505,102 in 2024. Accumulated deficit reached $9,783,143 as of December 31, 2025. Operating cash flow was negative $850,389 in 2025, improving from negative $664,066 in 2024. As of March 31, 2026, total assets were $1.5 million, total liabilities $5.4 million, and shareholder equity was negative $3.9 million.
Strategy
Accustem plans to launch MSC and StemPrintER in the US after achieving key milestones: transferring assays to lab partner EmeritusDx, obtaining CLIA certification, and establishing testing capabilities. Management estimates it will take approximately six months to complete these milestones. The company aims to expand StemPrint to other tumor types and offer ancillary commodity testing. Initial commercialization will focus on the US market.
Risks
- No approved products or revenue — The company has no products approved for commercial sale and has never generated revenue, with net losses every year since inception.
- Lack of utility study collaborations — The company has not identified institutions for clinical utility studies and has no agreements in place, which could delay reimbursement and commercialization.
- CLIA laboratory certification risk — The company does not yet have a CLIA-certified lab partner to run its tests as LDTs, and certification is outside its control.
- Negative shareholder equity — As of March 31, 2026, shareholder equity was negative $3.9 million, indicating a substantial accumulated deficit and potential going-concern risk.
Outlook
Management anticipates completing lab transfer and CLIA certification in about six months, after which it plans to launch MSC and StemPrintER in the US. The company expects to secure reimbursement and clinical utility, but acknowledges risks in achieving these goals. No revenue guidance or specific financial outlook was provided.