NEW YORK – Oncocyte said this week that it has signed an agreement with Qiagen to support the launch of sotorasib (Amgen's Lumakras) through Qiagen's "Day One" lab readiness program, which is designed to expedite patient access to Qiagen companion diagnostic tests following regulatory approval of the tests and associated drugs. Last week, sotorasib received US Food and Drug Administration approval for previously treated, locally advanced, or metastatic non-small cell lung cancer patients whose tumors harbor a KRAS G12C mutation. It was approved alongside Qiagen's Therascreen KRAS RGQ PCR kit, a tissue-based companion diagnostic, and Qiagen selected Oncocyte as a "Day One" lab that will offer the assay. Oncocyte noted that the Qiagen tissue test complements its own DetermaRx assay for early-stage NSCLC patients, as well as its DetermaTx and DetermaIO tests for later-stage patients, which the company plans to launch in the second half of this year.
Myriad Genetics this week said it has completed the sale of its myPath melanoma test and the lab in which the test is performed to Castle Biosciences. Utah-based Myriad had announced in April that it planned to sell these assets to Castle for $32.5 million in cash, as part of a broader restructuring plan. The sale was finalized on May 28.
The US Food and Drug Administration this week issued an update to Mesa Biotech’s Accula SARS-CoV-2 test, saying the assay could be affected by a genetic mutation at positions 28877-28878 (AG to TC) in patient samples. The FDA provided the update out of “an abundance of caution” as the impact does not appear to be significant. It previously published information about an impact to the test’s performance resulting from a genetic mutation at positions 28881-28883 (GGG to AAC).
Vienna, Austria-based omics firm Lexogen said this week it has received ISO 9001:2015 certification from TÜV Austria CERT for its quality-management system, which encompasses the research, development, and production of RNA analysis solutions, and the provision of bioinformatics products and services for RNA analysis. ISO 9001:2015 is a globally recognized quality management standard developed and published by the International Organization for Standardization.
PamGene International said this week that it has received an extension of its ISO 13485:2016 certification. The company said that the extension, which includes manufacturing, is an important component of its provision of in vitro diagnostic assay services for the prediction of immunotherapy response in oncological diseases using its IOpener kinome-activity profiling liquid biopsy tests. PamGene obtained its initial ISO certification in January 2019.
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.