Sense Biodetection has announced a strategic agreement with TECOmedical for nonexclusive distribution of Sense’s Veros COVID-19, the first test on the Veros molecular testing platform.
Effective immediately in Germany and Austria, and pending regulatory approval in Switzerland, the agreement is the latest in Sense’s planned European Union distribution partnerships as it commercializes its Veros platform.
The self-contained, single-use Veros COVID-19 product produces polymerase chain reaction (PCR)-quality results in about 15 minutes and is unconstrained by a reader or need for external power. Veros is the first instrument-free, single-use, rapid, point-of-care molecular COVID-19 diagnostic testing platform that produces lab-quality results in approximately 15 minutes, according to the company.
Veros COVID-19’s clinical performance was established in a multicenter study that prospectively enrolled nearly 300 evaluable subjects during both the delta and omicron variant surges of the pandemic. All study sites represented near-patient testing or point-of-care environments, with all test operators reporting no prior formal laboratory training or experience.
Operators reported that the Veros COVID-19 was user-friendly and provided clear results with minimal hands-on time required, according to Sense officials.
LabCorp Acquires New Jersey Outreach Lab Business
Labcorp recently announced that it has acquired RWJBarnabas Health’s outreach laboratory business and select related assets.
RWJBarnabas Health is New Jersey’s largest academic health system. Labcorp officials say the expanded relationship with RWJBarnabas will allow the system’s physicians and patients access to Labcorp’s expanded test menu and its extensive network of patient service centers, including those in Walgreens locations.
In addition, Labcorp will offer patients served by a RWJBarnabas Health laboratory expanded health plan coverage. Labcorp also offers enhanced service to rural markets and the potential for reduced out-of-pocket lab costs for patients. Same-day and stat testing will also be available in local communities, according to Labcorp officials.
RWJBarnabas officials said the acquisition is a strategic business decision that “enables a high-performing, streamlined outreach network to support its community.”
Illumina to Appeal European Commission's Decision on GRAIL Deal
After the European Commission’s (EC) recent decision to prohibit Illumina’s acquisition of Grail, Illumina announced that it intends to appeal the decision.
Illumina officials said they are disappointed with the EC’s decision prohibiting the acquisition. They added that Illumina can make Grail’s multicancer early-detection Galleri test more available, more affordable, and more accessible and can help save lives and lower healthcare costs.
Illumina said that a merger of the two companies would usher in a transformational phase in the detection and treatment of cancer by facilitating equal and affordable access to the Galleri test. The blood test can screen asymptomatic patients for more than 50 types of cancer and can identify the tissue where a cancer has developed. The company says Galleri is suitable for general population screening.
The merger would not only accelerate multicancer early detection in the European Union but would also reduce inequity in cancer care by making early diagnosis affordable and widespread, another key priority of Europe's Beating Cancer Plan, Illumina officials said.
Genomenon Integrates ClinVar Data Into Its Search Engine
Genomenon, an artificial intelligence (AI)-driven genomics company, has integrated all variants and pathogenicity interpretations from the ClinVar database into its Mastermind Genomic Search Engine.
This integration allows access via a single Mastermind search to patient variants found by genetic testing labs and submitted to ClinVar, along with the scientific evidence for these variants found across medical literature, the company said.
Mastermind has indexed more than 9 million publications containing over 19 million genetic variants, including about 18 million variants found in the medical literature but that are missing from the ClinVar database. More than 2,000 diagnostic labs currently use Mastermind, which is integrated into 18 clinical-grade decision support platforms and reference databases across the globe, according to Genomenon.
The company said that the integration allows Mastermind’s clinical users to contain their workflow within a single, searchable interface, accelerate diagnosis, and enrich clinical reporting with actionable insights not found in ClinVar. The integration also allows searchers to identify evidence in Mastermind that is otherwise missing from ClinVar, with the potential to change patient diagnoses and ensure proper treatment. Mastermind allows users to easily search using any variant nomenclature, which can lead to finding more evidence.
Genomenon officials added that integration of ClinVar data into Mastermind makes genomic analysis for clinical decision support faster, easier, and more effective.
PreludeDx and Galaxy Health Network Agreement Focuses on Novel Ductal Carcinoma in Situ Test
Prelude Corporation (PreludeDx) recently announced that it has signed an agreement with Galaxy Health Network to provide coverage for the company’s novel DCISionRT test for ductal carcinoma in situ (DCIS), also known as stage zero breast cancer. In the U.S., more than 60,000 women are newly diagnosed with DCIS each year.
Under the agreement, Galaxy’s more than 3.5 million members and 400,000-plus providers will have access to DCISionRT. PreludeDx officials said that DCISionRT predicts personalized recurrence risk and radiation therapy (RT) benefit for patients with DCIS. Personalized results provide physicians and patients with critical information to optimize DCIS treatment plans and avoid over or under treatment.
DCISionRT was developed by PreludeDx on technology licensed from the University of California, San Francisco, and built on research that began with funding from the National Cancer Institute. The technology enables physicians to better understand the biology of DCIS. The test provides a score that identifies a woman’s risk as low or elevated. Unlike other risk assessment tools, the DCISionRT test combines protein expression from seven biomarkers and four clinicopathologic factors using a non-linear algorithm to account for multiple interactions between individual factors to better interpret complex biological information. Clinicians receive a report of a woman’s recurrence risk after breast-conserving surgery alone and with the addition of radiation therapy.
This new information may help patients and their physicians to make more informed treatment decisions, according to PreludeDx.