NEW YORK – Agilent Technologies said this week that its instruments, kits, and reagents that were previously CE-IVD marked have now been released as IVDR Class A products to comply with the new EU IVDR rules, which went into effect on May 26. Under IVDR, products are classified into four categories, from Class D, considered to have a high risk to patients and the public, to Class A, considered to have a low risk. Agilent products deemed Class A span the firm's entire portfolio, including qPCR systems, sample prep instruments for next-generation sequencing, hematoxylin and eosin stains, staining equipment, and conjugated secondary antibody reagents, the Santa Clara, California-based company said.
Laboratory Corporation of America this week announced a new sponsored testing program aimed at guiding therapy in advanced non-small cell lung cancer (NSCLC) patients. Sponsored by Eli Lilly, the program will use Labcorp’s OmniSeq Insight test, a pan-cancer, tissue-based sequencing test to provide comprehensive genomic and immune profiling for cases meeting eligibility criteria.
The program is meant to increase awareness of NSCLC testing options, as well as improve access to such testing, so that patients can be tested for all guideline-directed genes and biomarkers, potentially making them eligible for treatments that would not be considered based on the results of single-gene testing.
The US Centers for Disease Control and Prevention said this week that it has launched an early warning variant detection program that will screen arriving international travelers for SARS-CoV-2 at four US airports. Called the Traveler-based SARS-CoV-2 Genomic Surveillance Program, it will use pooled samples and send selected positive samples to the CDC for variant characterization. The program is an expansion of an eight-week pilot project performed in collaboration with XpresCheck and Concentric by Gingko in 2021, with support from the CDC’s Advanced Molecular Detection (AMD) Program. The pilot reported the Omicron BA.2 variant in the US seven days before it was reported elsewhere in the country, and the BA.3 variant in North America 43 days earlier.
Grail and Ochsner Health said this week that they have partnered to improve cancer detection rates in Louisiana. Under the three-year program, Ochsner, through a collaboration between its Ochsner Cancer Institute and Precision Medicine program, will offer Grail’s Galleri multi-cancer early detection (MCED) liquid biopsy test to eligible patients in Louisiana. Ochsner researchers will also begin enrolling people age 50 or older in the ongoing PATHFINDER 2 study, a prospective, multi-center interventional study of the Galleri test that aims to enroll 20,000 participants through healthcare systems in North America. In addition, the organizations will identify educational gaps and access barriers to cancer screening, develop patient education materials, and reach out to communities about early cancer detection. The partnership also includes the launch of the MCED Health Equity Demonstration Program, which aims to improve cancer detection rates in underserved populations in Louisiana and develop a deployment model for innovative technologies in community settings.
NeoGenomics said this week that it has received certification from the College of American Pathologists for its pharma services laboratory in Suzhou, China, which was built in 2020. The firm said the certification is the “next step” toward NeoGenomics offering its pharmaceutical partners the opportunity to use the lab for trials of patients in China, whether in early discovery translational research or in clinical trial work for oncology drug development.
AnPac Bio-Medical Science this week reported a 10 percent year-over-year decrease in first quarter revenues. The company booked RMB 2.0 million ($309,000) in revenues in Q1, down from RMB 2.2 million in Q1 of 2021. Net loss for the quarter was RMB 14.9 million, compared to a net loss of RMB 29.2 million in the year-ago quarter. SG&A expenses amounted to RMB 13.2 million in Q1, down 43 percent from RMB 23.1 million in the same quarter in 2021. R&D costs totaled RMB 2.4 million, down 28 percent from RMB 3.4 million in Q1 of 2021. As of March 31, AnPac Bio had RMB 462,000 in cash and cash equivalents.
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.