NEW YORK – Applied DNA Clinical Labs (ADCL), a subsidiary of Applied DNA Technologies, said this week that it has submitted a validation package to the New York State Department of Health (NYSDOH) to support the approval of a pharmacogenomics assay as a NYSDOH laboratory-developed test (LDT). If approved, the LDT test will be used by ADCL to power its population-scale PGx testing services. The company said its commercial strategy is centered on the direct-to-enterprise and self-insured health markets that do not require ADCL to seek third-party reimbursement or engage in individual patient billing. In advance of initiating its PGx testing services, ADCL sales outreach has targeted regional health systems and large, self-insured entities in its New York operating area and in states that recognize New York's CLEP/CLIA certification. ADCL's PGx assay interrogates 120 targets across 37 genes relevant to a broad range of common drugs, including cardiac, pain management, cancer, and mental health therapies, yielding actionable information to enable healthcare providers to deliver personalized drug prescribing and dosing to their patients, the company said.
Enzo Biochem reported this week that its revenues were down 52 percent in the second fiscal quarter of 2023, to $16.3 million, compared to $34.0 million a year earlier. For the quarter ended Jan. 31, the firm reported a net loss of $11.3 million, or $.23 per share, compared to a net loss of $2.7 million, or $.05 per share, in the year-ago period. Enzo ended the quarter with $5.1 million in cash and cash equivalents. To explain the year-over-year revenue decline, the firm cited softer demand for COVID-19 testing during the most recent quarter and a bulk order received by its life sciences division during the year-ago quarter. Enzo also said this month that it had entered an agreement to sell the assets of its clinical laboratory division to Laboratory Corporation of America for about $146 million in cash.
Alveo Technologies said this week that it has received ISO 13485:2016 certification for its quality management system. Specifically, the certification is for the design, development, and manufacture of in vitro diagnostic kits and analyzers to detect infectious disease, the Alameda, California-based developer of molecular sensing and diagnostics said. Its flagship technology is the rapid, handheld Be.well platform, which leverages molecular assays with cloud-enabled data analytics for real-time disease, pathogen, and contaminant detection, analysis, and diagnosis. Earlier this year, the company signed a memorandum of understanding with the Barbados Investment and Development Corporation to codevelop Be.well with scientists in Barbados for assays in infectious disease, agriculture, veterinary, food, medicine, and aquaculture testing.
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