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The MMR RxDx Panel and Jemperli were approved by the FDA for use in endometrial cancer in April.

FDA grants marketing authorization to Enhanced Liver Fibrosis Test

Siemens Healthineers’ Enhanced Liver Fibrosis Test was granted marketing authorization under the de novo review pathway.

The ELF Test, for use with the Advia Centaur XP Immunoassay System, provides a numeric score that is automatically generated via an algorithm and is used to assess the likelihood of progression to cirrhosis and liver-related clinical events in patients with advanced fibrosis (F3 or F4) due to nonalcoholic steatohepatitis.

This marketing authorization follows the breakthrough device designation granted by the FDA for the ELF Test in 2018.

Siemens Healthineers develops AI-based COVID severity algorithm

Siemens Healthineers collaborated with several health care institutions worldwide to develop the Atellica COVID-19 Severity Algorithm, a model designed to help predict the potential likelihood of progression to severe disease and life-threatening multiorgan dysfunction in COVID-19 patients.

Using deidentified COVID-19 patient data from more than 14,000 COVID-19 patients, nine clinically significant lab parameters were identified and selected for inclusion in the algorithm. D-dimer, lactate dehydrogenase, lymphocyte %, eosinophil %, creatinine, C-reactive protein, ferritin, PT-INR, and high-sensitivity cardiac troponin I are used, in addition to patient age, to help predict the likelihood of disease progression to severe disease endpoints.

The educational-use-only algorithm is available on the company’s website (https://bit.ly/COVID_severe-alg). By entering a patient’s lab values and age, the algorithm will generate a COVID-19 clinical severity score, including projected probability of progression to ventilator use, end-stage organ damage, and 30-day in-hospital mortality. The AI-based algorithm has been interfaced to the Atellica Data Manager software and is being evaluated as investigational use only to assess benefit to patient care. With integration into the existing physician order/sample processing/result reporting workflow, a later generation of the algorithm could provide clinical decision support capabilities to support standardized testing protocols for patients positive for COVID-19.

Illumina acquires Grail

Illumina has acquired Grail with the aim of making Grail’s Galleri test broadly available and affordable.

Galleri is a multi-cancer early detection blood test that is available now but not covered by insurance.

Illumina says there is no legal impediment to its acquiring Grail in the United States, but in the European Union, where regulators are reviewing the transaction, Illumina says it will hold Grail as a separate company during the regulatory review.

Illumina announced a year ago its intention to reunite with Grail four years after it was spun off. Its acquisition of Grail, Illumina says, will accelerate access to and adoption of the Galleri test.