CLN - Industry Playbook
Alveo Technologies, Inc., along with faculty at Johns Hopkins University’s School of Public Health, recently announced the launch of an academic arm of its partner program, the Global Virus Network (GVN).
The effort’s primary goal is to make available a highly sensitive and easy-to-use platform to institutions and developing countries so they can proactively detect and track illness at the local level.
GVN now includes a research-use-only program focused on enabling innovative research through universities and academic partners. This deeper collaboration with Alveo aims to commercialize tests in countries with significant need, Alveo said.
The GVN and its more than 80 scientific sites, including Johns Hopkins School of Public Health, will help countries develop tests on Alveo’s open platform, which GVN said is well-suited for challenging environments, thanks to the devices’ ruggedness and portability.
According to Alveo, its device can withstand extreme temperatures, high humidity, shaking, and dropping. Researchers can proactively collect, detect, and track outcomes in Alveo’s cloud-based software solution, so test results can be accessed and aggregated from anywhere in the world.
The platform provides precise results comparable to PCR in terms of accuracy and sensitivity without requiring shipment of samples to a lab for processing. Alveo provides on-location results within 30−45 minutes or less.
The platform can upload geotagged results to the cloud, meaning researchers and authorities get near real-time information on a pathogen’s spread, regardless of where in the world the test is run, according to Alveo.
COOPERATIVE EFFORT ON NonInvasive Bladder Cancer Test in Europe
Menarini Diagnostics and Nucleix have announced a long-term commercial agreement for the exclusive distribution of the Bladder EpiCheck test in Europe.
The alliance between the companies aims to accelerate the adoption of the Bladder EpiCheck and transform bladder cancer patients’ care in Europe.
The noninvasive CE-marked test detects primary or recurrent bladder and upper tract urinary cancers. The European Association of Urology (EAU) Clinical Guidelines includes Bladder EpiCheck as a urine test that might be used in the initial diagnostic workup of bladder cancer to avoid or implement cystoscopy and in follow-up, to monitor for non-muscle invasive bladder cancer (NMIBC) tumor recurrence, or to replace or postpone cystoscopy. The test is also included in the EAU Clinical Guidelines as an ancillary tool in the diagnosis and monitoring of upper tract urothelial cancer.
Bladder EpiCheck could detect high-grade disease early and potentially reduce the frequency of cystoscopies, thus potentially reducing the burden of bladder cancer surveillance for patients and health systems, while improving patient outcomes by identifying the patients who will benefit most from intervention, the companies said.
DiaCarta Contract Focuses on VEXAS Syndrome Testing
DiaCarta recently announced a diagnostic testing service contract with the Department of Veterans Affairs San Francisco Veterans Affairs Health Care System to provide vacuoles, E1 enzyme, X-linked, autoinflammatory, somatic (VEXAS) syndrome testing.
The service includes the QClamp Plex VEXAS test developed at DiaCarta using its XNA technology and validated at its laboratory.
VEXAS syndrome is an autoinflammatory disease characterized by inflammation affecting various tissues and organs, causing bone marrow failure and high risk for clotting. The prevalence is 1 in 4,000. The disease typically occurs in men older than 50, but it is also rarely seen in women. It is distinguished by specific somatic gene mutations in the UBA1 gene.
Due to its diverse presentations, patients with the disease may be seen by doctors in various clinical specialties but remain undiagnosed or misdiagnosed with relapsing polychondritis, myelodysplastic syndrome, Sweet syndrome, or vasculitis.
DiaCarta officials said that the deal would enable better VEXAS syndrome testing, including improved sensitivity, turnaround time, and cost.
AI-Powered Cardiovascular Tests Get Preliminary Pricing from CMS
Cardio Diagnostics Holdings, Inc., has announced that its PrecisionCHD and Epi+Gen CHD tests have received preliminary pricing determinations from the Centers for Medicare & Medicaid Services (CMS).
PrecisionCHD is an artificial intelligence-powered blood test that aids in the diagnosis of coronary heart disease (CHD) by evaluating genetic and epigenetic markers. Epi+Gen CHD assesses the 3-year risk for a CHD event, including heart attacks, using a similar AI-driven, integrated genetic-epigenetic approach.
Preliminary CMS pricing determination marks a key milestone in gaining broad access to Medicare reimbursement.
The determination represents a crucial step toward securing Medicare reimbursement for the blood tests. The company says they can improve risk assessment, diagnosis, management, and monitoring of coronary heart disease (CHD).
If finalized, the decision will allow Medicare contractors to determine pricing for PrecisionCHD and Epi+Gen CHD based on actual cost data from Cardio Diagnostics.
Yourgene Health and Genetix Launch First Local NonInvasive Prenatal Testing Service in Colombia
Yourgene Health has installed Colombia’s first noninvasive prenatal testing (NIPT) workflow at Genetix.
Genetix has introduced its NipTest, a service that will utilize Yourgene’s IONA Nx NIPT Workflow to deliver fast, accurate NIPT results for expectant parents in Colombia.
Using Yourgene’s IONA Nx NIPT Workflow offers Genetix a complete CE-marked in vitro diagnostic device to establish its own quality-assured prenatal screening service in-house. The IONA test has been validated on a highly flexible and scalable workflow. It is suitable for low- to high-volume sample throughput and can enable growing clinical labs to meet rising demand.
The NIPT is performed using cell-free placental DNA from maternal blood to screen for trisomy 21 (Down’s syndrome), trisomy 18 (Edwards’ syndrome), or trisomy 13 (Patau’s syndrome). NIPT can also determine the sex of the fetus. The analysis is performed using next-generation sequencing technology, with test results available in 3 days.
Previously, blood samples collected in Colombia were sent to the U.S. for testing. By offering access to its NipTest locally, Genetix will help to ensure expectant parents receive reliable results quickly, while reducing the need for invasive tests and the associated stress and anxiety, according to Yourgene.
Read the full November/December 2024 CLN issue here.