NEW YORK – Agilent Technologies said this week that the South Korea Ministry of Food and Drug Safety has approved the firm's PD-L1 IHC 22C3 pharmDx as a companion diagnostic for identifying individuals with non-small cell lung cancer who are appropriate for first-line monotherapy with Merck's Keytruda (pembrolizumab) on the Dako Omnis platform. Santa Clara, California-based Agilent noted it is the third approval of the test as a companion diagnostic to identify NSCLC patients who are suitable for treatment with Keytruda. Dako Omnis is a fully automated system for staining tumor samples, Agilent said.
International infectious disease diagnostics organization FIND and Unitaid announced this week a $2 million investment to support advocacy for COVID-19 test-and-treat approaches in low- and middle-income countries. The initiative supports 21 in-country advocacy partners across 19 LMICs to develop and implement strategies that will improve uptake of test-and-treat approaches. The projects will raise awareness of COVID-19 testing and treatment among the public, key opinion leaders, and specific high-risk and vulnerable groups, the organizations said. This initiative complements a previously announced investment by FIND and Unitaid of $50 million to support early adoption of test-and-treat care packages.
Italian diagnostics firm Diadem said it has joined the UK-based public-private partnership Dementias Platform UK (DPUK) as a corporate partner. The company said it will work with the organization to evaluate the usefulness of Diadem’s AlzoSure Predict assay, a blood-based test for predicting progression to Alzheimer’s disease, as part of DPUK’s mission of accelerating the development of tools for diagnosing and treating dementia. Funded by the UK Medical Research Council, DPUK offers access to information on more than 3 million individuals from 50 long-term health cohort studies.
ProPhase Labs said this week it has partnered with an unnamed diagnostics firm for new clinical chemistry, immunoassay, hematology, hemostasis, and urinalysis analyzers as part of its strategy to expand its in-house clinical testing capabilities. The Garden City, New York-based company said that it has procured clinical testing equipment and executed a new lease for additional space at its corporate headquarters. It also plans to expand its in-house genomics testing menu. The new space will be used to expand its high-complexity molecular diagnostics lab services, including traditional clinical testing in multiple specialty areas. ProPhase is also building a new genomics lab in Garden City to include next-generation sequencers to conduct whole-genome sequencing and perform genetic tests for clinical use and research.
Nanomix said this week that it has received the EU Quality Management System Certificate for its eLab analyzer. The Emeryville, California-based company received the certificate under the new In Vitro Diagnostic Medical Devices Regulation, which took effect in May. The eLab analyzer is part of the Nanomix eLab system, a rapid, quantitative detection platform, consisting of a hand-held analyzer and a disposable cartridge. The system leverages nanobiosensor technology and provides results in minutes, Nanomix said.
The Breast Cancer Society of Canada said this week that it granted $250,000 in funding for a project to identify unique markers linked to HER2 breast cancer recurrence at Dalhousie University. The three-year project is led by Paola Marignani, a professor of biochemistry and molecular biology at Dalhousie. Its goal will be to develop precision therapies that prevent breast cancer recurrence.
Lunit this week filed a registration statement for an initial public offering on the Korean Exchange. The startup maker of artificial intelligence-based software for cancer, said that it will offer more than 1.1 million shares in the range of KRW 44,000 to KRW 49,000 ($34 to $38) per share as it looks to raise at least KRW 54 billion ($42 million).
The Seoul-based firm most recently was funded by a $26 million investment from Guardant Health in 2021. Lunit this year received the CE-IVD mark for its AI -based PD-L1 expression test, called Lunit Scope PD-L1 TPS, and is developing another test, called Lunit Scope IO, that can analyze the presence of tumor infiltrating lymphocytes in tumor tissue to predict checkpoint inhibitor response.
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.