Applied DNA Clinical Labs (ADCL), a subsidiary of Applied DNA Sciences, provides molecular and genomic testing services enabled by our expertise in DNA-based sciences and technologies. We serve businesses, healthcare providers, researchers and patients directly and through reliable and innovative clinical and reference laboratory services. ADCL is a NYSDOH CLEP-permitted, Clinical Laboratory Improvement Amendments (“CLIA”)-certified clinical laboratory certified to perform high-complexity testing.
Pharmacogenomics – TR8™ PGx
ADCL provides advanced pharmacogenomics services to optimize patient care through precision prescribing, enabling healthcare providers to personalize treatments based on genetic makeup for safer, more effective outcomes across multiple therapeutic areas.
The TR8 PGx test analyzes 120 genetic targets across more than 33 genes to inform healthcare providers about how a patient may respond to a wide range of drug therapies used to treat a variety of conditions, such as cardiovascular, oncology, psychiatric, and pain management. Equipped with information about a patient’s genome-based response to medications, healthcare providers can make more informed decisions when selecting prescription medications, thereby optimizing healthcare quality and efficacy. The test is administered via a simple cheek swab. The test is intended for clinical purposes and is available via prescription only.
The TR8 PGx test was developed, and its performance characteristics were determined by ADCL. The test has not been cleared or approved by the U.S. Food and Drug Administration. The TR8 PGx testing service offered by ADCL was approved as a laboratory-developed test by the New York State Department of Health (NYSDOH) in June 2024.
TR8 PGx for Pre-emptive Oncology Care
A recent safety alert by the Food and Drug Administration highlights that patients with certain DPYD genetic variants are potentially poor or intermediate metabolizers of these two medications due to DPD deficiency and risk drug overexposure and the potential to experience severe, and at times fatal, toxicities when taking them.
TR8 PGx for Pre-emptive Oncology Care allows for the pre-emptive testing of genetic variants of the DPYD gene in patients before they are prescribed fluoropyrimidine-based chemotherapy drugs, capecitabine (branded Xeloda) and fluorouracil (5-FU), which are widely used as part of the standard of care treatment for patients with certain cancers. This test can identify individuals with reduced or absent DPD activity to allow clinicians to adjust treatment plans by either choosing an alternative chemotherapy agent or by modifying the fluoropyrimidine dose.
Influenza A with Reflex to H5 Subtyping (H5 Bird Flu)
ADCL’s Linea™ Avian Influenza H5 Dx assay is a highly sensitive, multi-target diagnostic assay capable of detecting and discriminating between pan-influenza A and H5 bird flu. If the assay is approved by the New York State Department of Health, ADCL will launch an H5 bird flu testing service to accept samples originating in all U.S. states that recognize New York’s CLEP/CLIA certification, enabling physicians to order the test for patients suspected of infection.
H5 bird flu testing is a future planned service. The assay has been successfully validated by ADCL and is currently undergoing review by the New York State Department of Health as a laboratory-developed test. H5 bird flu testing is not currently available for clinical use and, if approved, will be available via prescription only.
COVID-19 Testing Services
With nearly one million tests performed, ADCL played a vital role in COVID-19 response, providing high-accuracy PCR testing for various sectors. Our ongoing services support safety, productivity, and continuity through comprehensive testing and result reporting.
Mpox Testing Solutions
Leveraging PCR-based DNA technologies, ADCL offers Mpox testing for Clade I and II MPXV as a specialized reference lab.
