CLN - Industry Playbook
The SpinChip platform delivers diagnostic results for detecting myocardial infarction (MI). Capable of producing results comparable with central laboratory diagnostic machines within minutes near the patient, the platform is particularly suited for emergency departments and urgent care units, according to SpinChip.
SpinChip plans to launch a highly sensitive troponin MI assay during 2026. The assay has already demonstrated strong results in a retrospective clinical study, the company reported. It is now undergoing additional national and international trials, including a large multicenter European clinical study.
SpinChip added that under bioMérieux’s ownership, it will develop additional immunoassays for acute care, focusing on sepsis and other cardiovascular biomarkers.
bioMérieux officials said that its acquisition will allow bioMérieux to apply its research, development, and manufacturing capabilities to immunoassays.
SpinChip officials said the transaction reflects the company’s advancements and that “bioMérieux is the perfect partner to drive SpinChip’s platform to commercialization and beyond.”
NCI recently announced it has selected two assays to be included in the Vanguard Study on multicancer detection tests, to be conducted by the Cancer Screening Research Network (CSRN).
The assays are ClearNote Health’s Avantect Multi-Cancer Detection Test and Guardant Health’s Shield.
In February 2024, the National Cancer Institute launched CSRN to evaluate emerging cancer screening technologies. In 2025, CSRN plans to launch the Vanguard Study to determine feasibility of using multicancer detection tests in future, randomized trials.
Vanguard will enroll up to 24,000 people and aims to determine whether the benefits of using multicancer detection tests outweighs harms and whether they reduce deaths.
Mainz Biomed N.V. has announced an agreement with Quest Diagnostics to support commercialization of Mainz Biomed’s next-generation screening test for colorectal cancer.
Mainz Biomed’s stool-based PCR ColoAlert test is designed to detect colorectal cancer tumor DNA to aid in identifying colorectal cancer in early stages. Preliminary data shows the test has promising sensitivity and specificity for colorectal cancer, including advanced adenomas, the company said.
Quest will provide clinical trial laboratory services for Mainz Biomeds’s ReconAAsense study, which will provide data to support FDA validation of the company’s next-generation test through a prospective clinical study and include approximately 15,000 subjects from 150 sites across the United States.
Mainz Biomed will provide Quest the option to exercise semiexclusive rights to provide testing services based on the test kit for an eighteen-month period, assuming it is approved by the FDA.
Mayo Clinic Laboratories and Lucence have announced a strategic collaboration to expand international access to cutting-edge cancer testing services.
Lucence will provide access to its LiquidHALLMARK technology through Mayo Clinic Laboratories. LiquidHALLMARK is an ultra-sensitive liquid biopsy that analyzes circulating tumor DNA and circulating tumor RNA for clinically relevant biomarkers across various cancers.
Reports from the Medicare-covered test reports include graphical maps for understanding cancer genomic profiles and tracking tumor changes over time, while delivering comprehensive information on each genomic finding, the companies said. The report also includes detailed descriptions of each finding and associated clinical trials.
Pharus Diagnostics LLC recently announced the availability of its OncoSweep Pancreas Spotlight, a liquid biopsy screening test that aids in the detection of pancreatic ductal adenocarcinoma (PDAC) in people with elevated risk.
PDAC is an aggressive form of disease with a poor prognosis. The blood test can help individuals at risk for the disease to undergo regular monitoring to detect early-stage disease when they have the most options for treatment, Pharus said.
The test uses a blood sample, next-generation sequencing, and a proprietary machine learning pipeline to analyze levels of microRNA and CA19-9 biomarkers.
In January of 2024, PharusDx entered into an exclusive global licensing agreement for a proprietary panel of microRNA biomarkers with testing data demonstrating potential value for early detection of PDAC with City of Hope.
Babson Diagnostics recently announced a new investment in its company by BD (Becton, Dickinson and Company), strengthens their long-term strategic partnership to expand access to blood testing.
The financing supports Babson’s launch of BetterWay blood testing at local pharmacies in Austin. BetterWay uses a small amount of blood — about the size of a pea — from a fingertip to diagnose and monitor a variety of chronic conditions, from hypertension to high cholesterol.
BetterWay integrates the BD MiniDraw with Babson’s proprietary sample preparation and hand-warming technologies to enable retail pharmacies to collect high-quality capillary samples without phlebotomists and laboratory technicians. Samples collected at pharmacies are analyzed using Babson’s proprietary microsample laboratory testing technologies at the company’s lab in Austin.
In December, BD received FDA 510(k) clearances for the BD MiniDraw Capillary Blood Collection System. It makes blood testing less invasive by eliminating needlesticks in the arm and the collection of large tubes of blood.
D research has found that needlesticks are an often-overlooked challenge for patients, the company said. About half of Americans report some fear of needles, and of that group, a top reason is fear of needing multiple needle insertions, according to BD.