[E-Daily Reporter KIM JI-WAN ] Psomagen, Inc.(950200)has secured certification from the New York State Department of Health, which is considered a key gateway to the U.S. genomic diagnostics market. This achievement is seen as laying a foundation of trust for the expansion of its global clinical diagnostics business, as it goes beyond simply being able to accept specimens from the New York area and demonstrates that the company has met the most stringent testing quality and accuracy standards in the United States.

Psomagen, Inc., a global specialist in genomic analysis, announced on the 18th of last month (local time) that it had officially obtained a Clinical Laboratory Permit in the field of “Molecular Genetic Testing” from the New York State Department of Health.

With this certification, Psomagen, Inc. has secured the legal authority to directly receive clinical specimens from patients in New York State, perform genetic testing, and provide the results.

New York State Certification = A Gateway to Premium Services

To operate a clinical laboratory in the United States, CLIA (Clinical Laboratory Improvement Amendments) certification—which meets federal standards—is generally required.

CLIA is a system that regulates the quality and accuracy of laboratories that analyze human-derived specimens—such as patient blood, tissue, and DNA—to aid in disease diagnosis or treatment decisions.

However, New York State goes a step further. Among the 50 U.S. states, New York is a prime example of a jurisdiction that requires its own clinical laboratory license in addition to CLIA certification.

Even testing facilities located outside New York State must obtain authorization from the Clinical Laboratory Evaluation Program (CLEP), operated by the Wadsworth Center under the New York State Department of Health, in order to analyze specimens from New York State patients.

CLEP conducts a comprehensive review of not only laboratory facilities and equipment but also test method validation, proficiency testing, staff qualifications, quality control, record keeping, and on-site inspections. It is regarded as one of the most stringent regulatory systems in the United States, particularly because it requires approval procedures for each individual test item.

Finnish diagnostics company Nightingale Health described obtaining New York State authorization as “an important milestone demonstrating compliance with strict regulatory standards.”

Direct Acceptance of Specimens in New York… A Foundation for Expanding the Customer Base Among Hospitals and Pharmaceutical Companies

The industry views the New York State license as a “gateway to business expansion.”

This is because the ability to directly accept patient specimens in New York State expands their service area to New York—one of the largest healthcare markets in the U.S.—and broadens the scope for contracting with hospitals, university hospitals, and pharmaceutical companies.

In particular, since New York State authorization itself is regarded as certification proving testing accuracy and quality control capabilities, it is seen as a factor that enhances competitiveness in the testing facility selection process by hospitals and pharmaceutical companies. Consequently, there have been a steady number of cases leading to the acquisition of new clients and an increase in testing volume.

Notably, global molecular diagnostics companies such as Foundation Medicine, Guardant Health, and Natera have expanded their business bases by providing clinical diagnostic services—including cancer genomic testing, liquid biopsy, and non-invasive prenatal testing—based on their New York State licenses.

In the genomic analysis business, reliability throughout the entire process—including specimen handling, data quality, test method validation, result interpretation, and reporting systems—is more important than the analysis equipment itself. In particular, hospitals and pharmaceutical companies consider a testing facility’s regulatory certification status a key selection criterion for clinical trials, companion diagnostics, and precision medicine research.

Hong Soo, CEO of Psomagen, Inc., stated, “Obtaining this certification holds deeper significance than simply being able to receive clinical samples from New York State,” adding, “Passing New York State’s strict standards strongly demonstrates the global-level quality and accuracy of Psomagen, Inc.’s CLIA-certified laboratory to the industry as a whole.”

He continued, “Now that we have the legal authority to directly receive patient samples from New York State—one of the largest healthcare markets in the U.S.—and provide diagnostic services, we expect to expand our sales and increase our market share in the U.S. in the future,” emphasizing, “Using this certification as a springboard, we will further expand our clinical diagnostic services and accelerate our efforts to provide top-tier genomic analysis services.”

Opportunity to Capitalize on the Rapid Growth of the U.S. Genomic Testing Market

The genomic

testing market

that Psomagen, Inc. is targeting is growing rapidly alongside the spread of precision medicine.

The global genetic testing market is projected to grow from $11.71 billion (18 trillion won) in 2024 to $39.25 billion (60 trillion won) by 2030. Within this market, North America is the largest region, accounting for 45.4% of revenue as of 2024.

Revenue growth among global leaders is also notable. Guardant Health, a liquid biopsy company, recorded revenue of $982 million (1.5024 trillion won) last year. Guardant Health provides a range of services, led by hospital-referred cancer genomic testing, as well as patient screening, biomarkers, companion diagnostics, and genomic data analysis for pharmaceutical companies and biotech firms.

Natera, a leading U.S. clinical genomics testing company, reported revenue of $2.3061 billion (3 trillion won) last year, a 35.9% increase from the same period the previous year. The company processes 3.34 million tests annually. Natera also reported first-quarter revenue of $696.6 million (1 trillion won) this year, a 38.8% increase from the same period last year. It is at the center of this explosive growth.

Exact Sciences, known for its colorectal cancer early-detection test “Cologuard,” recorded annual revenue of $3.25 billion (5 trillion won) last year. Myriad Genetics, a leader in hereditary cancer and prenatal testing, generated revenue of $824.5 million (1.2614 trillion won) last year.

Psomagen, Inc. is also experiencing high annual revenue growth, with 32.3 billion won in 2023, 43.7 billion won in 2024, and 59.2 billion won last year.

An industry insider stated, “With its New York State clinical laboratory accreditation, Psomagen, Inc. has effectively secured a crucial foundation to expand its business into the high-value clinical genomics testing market in the United States.”