The U.S. FDA has granted 510(k) clearance to a blood-based biomarker assay for disease monitoring of patients with metastatic breast cancer (MBC). The Divitum Tka assay, developed by Uppsala, Sweden-based Biovica International AB, measures the activity of the enzyme thymidine kinase-1 (TK1) which is highly associated with cell proliferation and a predictive marker of tumor aggressiveness. It is the first liquid cancer cell proliferation biomarker assay to be approved by the FDA for use in monitoring metastatic breast cancer.

Prognomiq Inc. secured access to 800,000 anonymized biological samples for analysis and detection of dynamic cancer biomarkers as part of a new partnership struck with Kahn-Sagol-Maccabi (KSM), the research and innovation center of Maccabi Healthcare Services, Israel’s largest health maintenance organization. The partnership will enable the creation of a biomarker platform the organizations hope will facilitate early diagnosis and improved outcomes for cancer patients using Prognomiq’s multiomics platform.

Bipolar disorder (BPD) is disabling, destructive and notoriously difficult to diagnose. Research indicates that up to 40% of patients diagnosed with major depressive disorder or unipolar depression actually have BPD and treating them with antidepressants alone runs an elevated risk of worsening their condition. But the issue is not one-sided: other studies found that 30% to 60% of patients diagnosed with BPD do not meet the clinical criteria for the illness and may be taking powerful mood stabilizers needlessly while failing to receive potentially beneficial therapies.

Volitionrx Ltd. won the CE mark for its Nu.Q NETs test for the detection, evaluation and management of NETosis, a type of cell death characterized by the release of neutrophil extracellular traps, or NETs. The test – the first biomarker approved for the measurement of NETs for patient management – will soon be available for clinical use across the E.U.’s 27 member states.

Metabolic health platform Ultrahuman Healthcare Ltd. has acquired consumer wearable company Lazy Design Pvt Ltd. India (known as Lazyco) to expand the biomarkers complementing its current wearable, the Ultrahuman M1.

Norwegian diagnostics company Cardinor AS landed a CE mark for its Secretoneurin (SN) ELISA (enzyme-linked immunosorbent assay). The blood-based test detects SN, a small 33-amino acid neuropeptide produced by neuroendocrine and heart muscle cells. Studies have shown the biomarker is a predictor of mortality in major patient cohorts, including ventricular arrhythmia, acute heart failure, acute respiratory failure patients with cardiovascular disease (CVD) and severe sepsis.

As attention turns to new drugs that can address the growing burden of Alzheimer’s disease (AD) in an aging global population, Retispec Inc. has developed a noninvasive test that may be able to detect early signs of the neurodegenerative disease decades before clinical symptoms appear – and when therapies appear to be most helpful in slowing or reversing Alzheimer’s. By using “off-the-shelf” ophthalmic equipment, the Toronto-based company’s solution enables assessment by optometrists or other eye professionals during a standard eye exam.

Cancer trials that stratify patients using biomarkers increase their likelihood of proceeding to the next phase more than 500% compared to trials run without biomarkers, Canadian researchers recently determined, and biotech companies have invested heavily in identifying new biomarkers for a wide range of applications. Genialis Inc. has tackled the problem of huge investment in biomarkers with little return by developing a platform that combines artificial intelligence and machine learning.

A recently published study demonstrated that Viome Life Science Inc.’s metatranscriptomic signature for oral cancer identified the malignancy from samples of saliva with more than 90% accuracy. The mRNA platform received breakthrough device designation from the FDA in May for both early-stage oral squamous cell carcinoma and oropharyngeal cancer.