New York, NY /PRNewswire/ - Phosphorus, a leader in diagnostic and bioinformatic solutions for clinical Next Generation Sequencing (NGS), announced that the company's laboratory completed the Clinical Laboratory Evaluation Program (CLEP) administered by the New York State Department of Health (NYSDOH) and has been issued its clinical laboratory permit in the category Genetic Testing - Molecular. Along with the laboratory permit, NYSDOH provided approval to two initial Phosphorus tests: one for Arrhythmias, Cardiomyopathies and Lipidemias, and another for Hereditary Cancers.
CLEP ensures proper performance of diagnostics laboratory tests, as part of the New York State Department of Health focus on the public health, safety and welfare of all NYS residents.
"We are very excited to have received approval from New York State for these first two tests," said Alex Bisignano, Phosphorus' CEO. "As New York State is widely considered to have one of the most rigorous review processes, we believe this approval accurately reflects the high standards of quality and scientific rigor that go into our test development process."
Both approved assays utilize blood and saliva, and they are NGS-based laboratory developed tests (LDTs) supported by Phosphorus Elements, an in-house developed LIMS platform, which is also available for commercial license. Along with Single Nucleotide Polymorphisms, the Phosphorus genetic tests are able to detect some of the more challenging genetic variations such as insertion-deletions, copy number variations, and variations in segmental duplications.
"CLEP provides the most rigorous evaluation of laboratory developed tests, therefore we believe that meeting these standards not only allows us to validate the quality and accuracy of our tests, but also helps us to impact the reliability of the genetic tests used in optimizing healthcare decisions," stated Malgorzata Jaremko, SVP and laboratory director of Phosphorus. "We are also excited that residents in NY state will now have access to our technology, making our services available across all 50 states in the U.S."
Phosphorus's mission is to improve human health by better understanding and harnessing the power of the human genome. Having built the most comprehensive, high-quality, and cost-effective portfolio of genetic tests, Phosphorus is able to increase access and quality of care in the burgeoning field of genomics. The company currently provides panel-based, constitutional genetic testing in the specialty areas of Fertility, Cardiology, Lipidology, Oncology, Pharmacogenetics, Ophthalmology, Neurology, and Pediatric/Metabolic disorders. Phosphorus also offers the PhosphorusONE proactive health screen - the most comprehensive genomic test for taking a proactive look at your health. Additionally, Phosphorus provides the Elements™ software platform to enable any laboratory to easily deploy any of the Phosphorus genetic tests on-premise as a local solution. For more information, please visit our website at phosphorus.com.
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