Roche, Illumina partner to broaden access to genomic testing
February 2020—Roche has entered into a 15-year, nonexclusive partnership with Illumina to broaden the adoption of distributable next-generation-sequencing–based testing in oncology. The agreement brings together the capabilities of both companies to broaden adoption of NGS in cancer care.
As part of the agreement, Illumina will grant Roche rights to develop and distribute in vitro diagnostic tests on Illumina’s NextSeq 550Dx system and on its future portfolio of diagnostic sequencing systems. Roche will in turn collaborate with Illumina to complement Illumina’s comprehensive pan-cancer assay TruSight Oncology 500 with new companion diagnostic claims. The financial terms of the deal were not disclosed.
Under the IVD terms of the agreement, Roche will develop, manufacture, and commercialize Avenio IVD tests for tissue and blood for use on Illumina’s NextSeq 550Dx. Illumina will continue to sell the NextSeq 550Dx systems and core sequencing consumables. Under the companion diagnostic terms of the agreement, Roche and Illumina will develop and pursue CDx claims on TruSight Oncology 500 for both existing and pipeline Roche oncology targeted therapies on the NextSeq 550Dx. Illumina will lead the development and regulatory approval process and continue to manufacture, supply, and commercialize TruSight Oncology 500. Roche will support the development of the claims and regulatory filings.
Siemens adds fentanyl assay to its menu
Siemens Healthineers is distributing the Ark Fentanyl Assay, manufactured by Ark Diagnostics. The assay extends the detection window to provide the information clinicians need to triage their patients more appropriately.
Fentanyl absorption occurs at different rates depending on the type of exposure. Fentanyl is metabolized to norfentanyl and other metabolites. About 90 percent of the dose is excreted in urine as norfentanyl; parent fentanyl accounts for less than seven percent. Because fentanyl metabolizes quickly, assays measuring solely the parent fentanyl typically have a shorter window for detection. The Ark Fentanyl Assay can detect norfentanyl and the parent fentanyl, Siemens said, enabling laboratories to identify more true positives.
“Adding the Ark Fentanyl Assay to the Atellica Solution menu offers laboratories an extensive drugs-of-abuse testing menu which can be run efficiently on a single instrument,” Deepak Nath, PhD, president of laboratory diagnostics, Siemens Healthineers, said in a Jan. 15 statement. “It also empowers laboratories to help identify exposure and addiction in their communities, and aid clinicians in getting patients on the path to treatment.”
Qiagen to collaborate with Amgen for CDx development in NSCLC
Qiagen announced a strategic collaboration to develop tissue-based companion diagnostics for Amgen’s investigational cancer treatment AMG 510 to identify patients with cancers that have the KRAS G12C mutation. The agreement focuses initially on companion diagnostics for non-small cell lung cancer but allows for further development of the tests for Amgen’s other oncology clinical development programs.
The Therascreen-based companion diagnostic will screen for KRAS G12C. “With one in eight patients with NSCLC having KRAS G12C, there’s a critical need to improve access to high-quality diagnostics and more routine screening,” David M. Reese, MD, executive vice president of research and development at Amgen, said in a Jan. 13 statement.n