Galatea Bio Launches StrataRisk™ Polygenic Risk Score to Scale Common Disease Risk Assessment and Reporting at the 2025 ACMG Conference

/EIN News/ -- MIAMI LAKES, Fla., March 18, 2025 (GLOBE NEWSWIRE) -- Galatea Bio, a leader in precision health, announced today the launch of StrataRisk™, a Polygenic Risk Score (PRS) Software-as-a-Service (SaaS) platform designed to assess the polygenic contribution to common diseases such as cardiovascular, metabolic disorders and cancer susceptibility. StrataRisk PRS will be showcased at the 2025 American College of Medical Genetics and Genomics (ACMG) Conference in Los Angeles, March 19–21, 2025, where the company will also present a scientific study demonstrating the platform’s applications.

Key highlights of StrataRisk™ PRS
StrataRisk PRS leverages a novel, patent-pending algorithm powered by AI to dynamically select and integrate polygenic risk score (PRS) models from genome-wide association studies (GWAS). It calibrates these models against genetically similar individuals from Galatea’s Global Biobank database, ensuring precise risk assessment regardless of patients' ethnic background. StrataRisk PRS is offered as a SaaS solution, enabling clinical laboratories to integrate StrataRisk PRS into their workflow delivering actionable insights for patient care.

By combining StrataRisk PRS with traditional gene panel testing, laboratories can provide a differentiated approach to genomic interpretation by evaluating both rare variants in disease genes and cumulative polygenic risk. This approach refines risk stratification and enables medical providers to personalize screening recommendations.

Addressing the Limitations of Traditional Genetic Testing
Traditional single-gene or multi-gene panel testing primarily detects rare, high-penetrance mutations, which explain only a fraction of the hereditary disease and cancer risk. This approach can lead to negative or inconclusive results, leaving patients without a clear understanding of their overall genetic risk.

By integrating Galatea StrataRisk PRS into NGS-based genetic testing, laboratories can now provide a more comprehensive risk assessment, identifying more at-risk individuals who may otherwise be missed (i.e., “high risk mutation negatives”). A key advantage of StrataRisk PRS is its ability to individually adjust risk scores based on a person’s genetic neighborhood, overcoming the limitations of many existing PRS models, which are predominantly trained on populations of Northern European ancestry or rely on crude race/ethnicity-based adjustments.

This combined strategy further refines the identification of high-risk individuals across multiple diseases, offering a more actionable tool for personalized risk management. By addressing these limitations, labs incorporating StrataRisk PRS alongside gene panel testing can deliver more comprehensive and accurate genetic risk assessments, empowering patients and clinicians to make better-informed healthcare decisions.

StrataRisk PRS is initially available for eight cardiovascular and metabolic traits: atrial fibrillation, coronary artery disease, hypertension, elevated triglycerides, elevated LDL, decreased HDL, hypothyroidism, and type 2 diabetes. The next release will expand coverage to include hereditary cancer traits, including breast, ovarian, colorectal, lung and prostate cancer.

Scientific Presentation on StrataRisk at ACMG 2025
Galatea Bio will present research showcasing the accuracy and portability of StrataRisk PRS across non-European descent patients in a scientific poster (#P310) titled: “Polygenic and rare variant contributions to the genetic architecture of familial hypercholesterolemia in a Mexican registry cohort,” presented by Francisco M. De La Vega, D.Sc., CTO of Galatea Bio, on Friday March 21 from 10:30AM - 11:30AM Pacific Time at the LA Convention Center Exhibit Hall.

This study examines the contribution of both rare, highly penetrant and common variants (summarized as a polygenic risk score) to the disease burden in a cohort of 300 admixed patients meeting the diagnostic criteria for Familial Hypercholesterolemia (FH). Using StrataRisk PRS, we composed a high-performing PRS model for elevated LDL cholesterol and applied personalized calibration for each patient. Our findings highlight how StrataRisk PRS enables accurate risk classification, revealing that patients in the cohort have a disproportionately high polygenic burden for FH—particularly those who do not carry rare variants in classical FH genes. These results confirm that a comprehensive risk assessment for FH requires a combined approach, incorporating both rare variant screening in FH-associated genes and polygenic risk assessment.

“A new era in genetic testing has arrived,” said Carlos Bustamante, Ph.D., CEO & Co-Founder, Galatea Bio. “StrataRisk PRS empowers clinical genetic labs to deliver more informative reports to healthcare providers, leading to earlier interventions, improved patient care, and proactive lifestyle changes that promote long-term wellness.”

About Galatea Bio

Galatea Bio is a venture-backed biotechnology company dedicated to advancing “Precision Health at Scale for All.” Founded by pioneers in population genetics and bioinformatics, Galatea Bio leverages cutting-edge AI algorithms, a clinical genetics laboratory, and global biobank to bring precision health solutions to markets while maintaining a strong commitment to ethical research in underserved populations. The company is headquartered in Miami Lakes, Fla. For more information, visit www.galatea.bio and follow us on LinkedIn.

Disclaimer
StrataRisk PRS is a software component of a laboratory-developed test (LDT) intended for use with data from a CLIA-certified, CAP-accredited laboratory. This LDT (including the StrataRisk PRS software) has not been cleared or approved by the U.S. Food and Drug Administration (FDA) and is not an FDA-approved in vitro diagnostic device for standalone use.

Media Contact

Kimberly Ha

KKH Advisors

917-291-5744

kimberly.ha@kkhadvisors.com