Novel liquid biopsy test powered by proprietary AmpliMark™ technology identifies Clonal Hematopoiesis (CH) mutations, which can help address a critical gap in preventive healthcare.

PALO ALTO, CA., January 12, 2026 — Lucence, a leading precision oncology company, announced the availability of CardioHemeRISK™ for physicians in the United States. This novel blood test uses ultra-sensitive next-generation sequencing (NGS) to detect somatic mutations associated with Clonal Hematopoiesis (CH), a condition related to aging and lifestyle, linked to increased risks of cardiovascular events and leukemia. 

Studies suggest that 1 in 4 heart attack patients [1] and 1 in 5 stroke patients [2] have no known risk factors. CardioHemeRISK™ may help to address this diagnostic gap by screening for CH mutations, which have been associated with up to 12 times greater risk of heart attack [3], 3.1 times greater risk of stroke [4], and 12.9 times greater risk of leukemia [5] compared with the general population.* CH mutations may affect up to 39% of individuals above 60 years of age according to research. [6]

"While standard screening methods have improved, too many patients still suffer life-threatening cardiovascular events or leukemia diagnoses without warning," said Dr. Tan Min-Han, Founder and CEO of Lucence. "Launching CardioHemeRISK™ in the U.S. represents an important step forward for Lucence as we scale our platform. By bringing this test to the U.S. physicians, we are extending our liquid biopsy technology beyond cancer therapy selection into preventive health. CardioHemeRISK™ was designed to empower physicians to identify markers associated with certain silent biological drivers early, which can offer the possibility of proactive management that could ultimately save lives."

CardioHemeRISK™ leverages Lucence’s proprietary AmpliMark™ technology to screen for 15 key CH-related genes. The same high-sensitivity platform powers LiquidHALLMARK^®, the company's Medicare-reimbursed test that identifies clinically actionable biomarkers to help inform targeted therapy selection, subject to the treating physician’s medical judgement. 

Currently, CH is not routinely screened in clinical practice [7], leaving a significant population unaware of their potential risk. CH mutations are more common in individuals who:

• Are aged 40-79 [4, 8]

• Have cardiovascular risk factors (hypertension, diabetes, smoking, or family history) [9]

• Have experienced a cardiovascular event [9]

• Have prior exposure to chemotherapy or radiation [9]

CH testing is not recommended for individuals who have received a bone marrow transplant at any time, or who have had a blood transfusion within the past 2 weeks.

CardioHemeRISK™ is available for ordering by physicians throughout the United States. Further information is accessible at www.lucence.com/solutions/cardio-heme-risk-us

For media enquiries, please contact inquiry@lucence.com

About Lucence

Lucence is a precision health company committed to accelerating the world towards people living longer and healthier lives, enabled by earlier and non-invasive detection of markers associated with cancer and other aging diseases. Its ultra-sensitive liquid biopsy tests are based on proprietary AmpliMark™ sequencing technology, designed to detect cancer-related genetic alterations with high sensitivity and specificity. Headquartered in Palo Alto, California, and Singapore, Lucence provides testing services through CLIA-certified and CAP-accredited laboratories.

References

*Risk was derived from publications measuring hazard ratios (HR) of patients with CH mutations > 10% variant allele frequency (VAF).

[1] Paul, G. et al. Global Heart 2023; 18(1): doi: 10.5334/gh.1189.

[2] Beharry, J. et al. Eur Stroke J. 2025; doi: 10.1177/23969873241309516.

[3] Early onset myocardial infarction: HR = 12; 95% CI, 3.8–38; P < 0.001 (Jaiswal, S. et al. N Engl J Med 2017; 377(2): 111-121. PMID: 28636844).

[4] Ischemic stroke: HR = 3.1; 95% CI, 1.2–8.4; P = 0.025 (Jaiswal, S. et al. N Engl J Med 2014; 371(26): 2488-2498. PMID: 25426837).

[5] Hematologic cancer: HR = 12.9; 95% CI, 5.8–28.7; P < 0.001 (Genovese, G. et al. N Engl J Med 2014; 371: 2477-2487. PMID: 25426838).

[6] van Zeventer I, et al. Cancer Cell 2023; 41(6): 1017-1031.e4

[7] Weeks L and Ebert B. Blood 2023; 142(26): 2235-2246.

[8] van Zeventer, I. et al. Blood Adv 2021; 5(8): 2115-2122

[9] Jakubek Y, et al. Transl Res 2023; 255: 171-180. doi: 10.1016/j.trsl.2022.11.009

LiquidHALLMARK and CardioHemeRISK were developed and their performance characteristics determined by Lucence Health Inc. They have not been reviewed, cleared, or approved by the US Food and Drug Administration ("FDA"). As Laboratory Developed Tests, the FDA does not require these tests to undergo FDA premarket review.