Clinical Laboratory (CLIA) Services
Asuragen is continually applying its expertise in the discovery and development
of miRNA diagnostics. In order to introduce these new miRNA-based laboratory developed
tests (LDTs), Asuragen has increased its extensive services capabilities via an
addition of a CLIA laboratory. This laboratory is the exclusive provider of Asuragen’s
clinical tests.
Asuragen’s pancreatic miRNA test is the first miRNA-based diagnostic test in the
world. This test was developed to aid physicians in the differential diagnosis and
disease management of pancreatic ductal adenocarcinoma. The pancreatic cancer test
is an important proof of principle of the utility of miRNAs as diagnostic analytes.
Other promising miRNA-based diagnostic tests are under development.
Asuragen KRAS and BRAF Laboratory developed tests (LDTs), validated in the CLIA
lab, are intended to be used and interpreted in conjunction with all other available
clinical and laboratory information when evaluating anti-EGFR treatment options
for colorectal cancer patients.
The CLIA laboratory was also launched with our pharmaceutical development partners
in mind, and allows Asuragen to offer more comprehensive assay development services
and clinical samples testing.
Our commitment to excellence
We, like many of our clients, work in a regulated business environment (cGMP, cGLP,
CLIA, and HIPAA compliance) where federal and international laws and regulations
govern our conduct. In addition, we abide by other international standards because
these have been shown to systematically improve quality. We take these various aspects
of compliance seriously at all levels within our organization, and our clients can
see it in our communications and deliverables.
At Asuragen, Inc. we take the utmost care in the recording and storage of patient
information necessary to ensure confidentiality. All Asuragen clinical laboratory
personnel are trained in confidentiality and other clinical laboratory procedures.
According to the regulations, tests results or reports will only be disclosed to
authorized persons (healthcare provider who orders the test), as defined by state
or federal law.
Pancreatic miRNA Test
Learn More
KRAS and BRAF Testing
Learn More