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New Cancer Diagnostic Tests Stand Out

by | Jan 24, 2023 | News, Open Content

Key Dx announcements last week involved companion diagnostics, liquid biopsy assays, and an RUO leukemia test.

Key new approvals, product releases, and partnerships involving diagnostic tests over the past week mainly dealt with cancer diagnostics, with four of six announcements relating to diagnosing the disease. In addition to those cancer Dx announcements, sepsis and HIV were the focus of other key test news.

Jan. 18: Medical diagnostics company Cytovale announced it had received FDA 510(k) clearance for its IntelliSep® Sepsis Test for early detection of the condition in emergency department patients presenting sepsis symptoms.

Jan. 23: Agilent Technologies announced it’s teaming up with Quest Diagnostics to offer expanded access to Agilent’s Resolution ctDx FIRST liquid biopsy next-generation sequencing companion diagnostic for identifying non-small cell lung cancer (NSCLC) patients who may benefit from treatment with KRAZATI (adagrasib).

Jan. 23: Molecular diagnostics company BillionToOne, Inc. launched its Northstar liquid biopsy assays, which have been designed to work together to help guide treatment decisions for people with late-stage solid tumors.

Jan. 23: Montana-based Alercell launched its new Research Use Only leukemia diagnostic test, LENA Q51®, for commercial sale. The test, which detects 51 gene mutations related to leukemia for early detection of the disease, is also currently going through the FDA regulatory submission process to be approved “for broader clinical use,” the company said in its statement.

Jan. 24: Thermo Fisher Scientific had a pair of key announcements, one involving its partnership with AstraZeneca to develop a companion diagnostic to help identify people with NSCLC who may benefit from treatment with Tagrisso (osimertinib). That same day, Thermo announced the launch of its CE-IVD marked Sanger sequencing-based assay, the Applied Biosystems TaqPath Seq HIV-1 Genotyping Kit for helping identify treatment-resistant strains of HIV-1.

Look for more analysis of some of these and other key announcements in our Laboratory Industry Report.