NEW YORK – Applied DNA Sciences said on Friday that its wholly owned clinical laboratory subsidiary, Applied DNA Clinical Labs (ADCL), has submitted a validation package for its monkeypox virus test to the New York State Department of Health in support of a request for a full approval as a NYSDOH laboratory-developed test. The PCR-based diagnostic, called the Linea Monkeypox Virus 1.0 Assay, is designed to identify the genetic signature of the clade II variant of the monkeypox virus that is currently prevalent in the US. If approved by the NYSDOH, the assay will be used as part of ADCL's monkeypox testing services at its CLEP/CLIA molecular diagnostics laboratory in Stony Brook, New York, the company said.
LumiraDx on Thursday reported that its second quarter revenues dropped 49 percent to $44.7 million from $87.2 million in the year-ago quarter, driven largely by lower COVID-19 testing demand. Test strips on the LumiraDx platform accounted for $28 million in revenues, while Fast Lab Solutions’ molecular reagents delivered $10 million, almost entirely from COVID-19 products, the company said. LumiraDx’s net loss for Q2 was $147.5 million, or $.58 per share, compared to a loss of $15.4 million, or $.12, in 2021. The firm ended the quarter with cash and cash equivalents of $106.5 million. The company said it has begun a global restructuring plan to resize the organization and reduce operating costs in order to avoid impacting its pipeline.
Lucid Diagnostics this week reported no revenues in preliminary financial results for the second quarter, the same as a year ago. It said that because of an extended transition period after the opening of its LucidDx Labs and the onboarding of a new revenue cycle management partner, initial claims by the partner did not occur until after the end of the second quarter. Because recognized revenues on a GAAP basis are measured by actual collections during the quarter, no EsoGuard revenues were recorded during Q2 2022 although 850 tests were performed during the quarter. The consensus Wall Street revenue estimate was $640,000. The company said that it had a net loss of $14.6 million, or $.41 per share, for Q2 2022 compared to a net loss of $6.2 million, or $.44 per share, a year ago. On an adjusted basis, the firm had a loss per share of $.28 per share for the recently completed quarter, beating the consensus Wall Street estimate of a loss of $.33 per share. Lucid finished Q2 2022 with $32.7 million in cash and cash equivalents.
Nanomix said this week it has received ISO 13485:2016 certification for its new facility in San Leandro, California. The company noted that it began transitioning to its new 9,327-square-foot manufacturing facility in April. Nanomix Chief Operating Officer Vidur Sahney said that the certification marks the scale-up of its manufacturing to meet customer demand for the eLab S1 critical infection panel and other products.
Strata Oncology this week added eight sites affiliated with the Sarah Cannon Research Institute to its Strata PATH clinical trial. Patients can now be enrolled through Florida Cancer Specialists; Genesis Cancer and Blood Institute in Hot Springs, Arkansas; Hematology Oncology Clinic in Baton Rouge, Louisiana; Tennessee Oncology in Chattanooga, Tennessee; and Zangmeister Cancer Center in Columbus, Ohio. The Strata PATH trial is evaluating several US Food and Drug Administration-approved drugs in biomarker-guided patient populations. In May, the trial began enrolling patients with advanced solid tumors or early-stage cancer patients who have evidence of micro-metastatic disease.
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