NEW YORK – Roche this week announced that its Elecsys PTau217 plasma biomarker test for Alzheimer's disease has received breakthrough device designation from the US Food and Drug Administration. The test is being developed in collaboration with Eli Lilly and once it is approved it will be used to help clinicians identify amyloid pathology, a key feature of Alzheimer's, Roche said in a statement. The assay is intended to detect phospho-tau (217P) in plasma in people aged 60 or older. A positive result indicates a high likelihood of having a positive amyloid PET/CSF result, Roche noted, and the test's results could be used to determine participation in clinical trials or treatment with approved therapies.
Aspira Women’s Health announced this week a new agreement with Anthem Blue Cross in California for coverage of its OvaSuite test portfolio effective June 1, 2024. Anthem Blue Cross will provide coverage for its commercial and government lines of business, including Medicare Advantage and Medicaid, which represent about 6 million covered lives in California.
Laboratory Corporation of America this week declared a cash dividend of $.72 per share of common stock. The dividend will be payable on June 12, 2024, to stockholders of record as of the close of business on May 28, 2024.
Mainz Biomed said this week that its 2023 revenues rose 69 percent to $895,479 from $529,877 in 2022. The German cancer diagnostics developer posted a net loss of $26.3 million, or $1.62 per share, in 2023 compared to a net loss of $26.4 million, or $1.86 per share, a year ago. Its R&D spending increased to $9.6 million from $5.0 million, while its SG&A costs ticked down to $17.6 million from $21.6 million. Mainz ended 2023 with $7.1 million in cash.
Agendia said this week that the German Gynecological Oncology Working Group (AGO) has included its 80-gene molecular subtyping assay, BluePrint, to its guidelines. The assay was added to a list of predictive factors for neoadjuvant chemotherapy decision making. Last year, AGO added Agendia's MammaPrint to the list of prognostic and predictive factors for extended endocrine therapy. That test has also been part of the guidelines since 2017 as level 1B medical evidence for identifying patients who can potentially forgo chemotherapy for breast cancer.
German genomics and genetic testing company CeGaT said this week that B. Braun has sold its shares in the company back to its founders, Saskia and Dirk Biskup, effective April 1. Both firms "will be pursuing different strategic directions in the future despite a longstanding and trusting collaboration," according to Tübingen-based CeGaT, and are no longer collaborating. B. Braun, a global medical device company, invested an undisclosed amount in CeGaT in 2012, taking a 20 percent ownership stake in the firm. In 2014, the companies opened a US subsidiary and in 2018, they partnered to offer genetic testing services in China. That same year, they also created a joint venture, CeCaVa, to develop personalized vaccines for cancer and other diseases. CeGaT also said it opened new office and laboratory space, tripling the size of its existing building.
Israeli firm EFA Technologies this week said that it has raised $6.5 million to accelerate product development, expand its market, and further innovate in the diagnostics space. The Series A round was led by E-Health Ventures, Maccabi HMO, Venturing Tech, ARC Impact ventures, and the Israeli Innovation Authority. EFA Tech has raised a total of $12.5 million, a company official said. The firm also said that it is entering the Brazilian market following the regulatory approval by Anvisa, the Brazilian regulatory authority, in October of its lead product, the RevDx portable diagnostic device. RevDx leverages microscopy and AI technology to perform a full complete blood count from a drop of blood.
Telo Genomics said this week that its laboratory in Toronto has been accredited by the College of American Pathologists. As part of the accreditation process, inspectors review a laboratory's records and quality control of procedures, safety program and record, and overall management. Telo's telomere platform is for use in applications including liquid biopsies.
In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.