CLN - Industry Playbook
The health and wellness company Hims & Hers Health recently announced plans to introduce at-home lab testing through its platform.
The company acquired an at-home lab testing facility, Sigmund NJ LLC, marketed as Trybe Labs. The acquisition will allow Hims & Hers to support at-home blood draws and more comprehensive testing, the company said.
The acquisition also allows Hims & Hers to offer a wide range of personalized treatments, supplements, and medications, while accelerating expansion into new clinical categories, including low testosterone, perimenopausal, and menopausal support, Hims & Hers added.
Using a blood lancet, customers will be able to learn more about their hormone levels, cardiac risk, stress markers, cholesterol, liver function, thyroid function, and prostate health.
Providers on the platform will then be able to use that information to help inform personalized treatment plans most appropriate for their individual patients, the company noted. Additionally, de-identified lab data will accelerate the company’s artificial intelligence developments, including MedMatch by Hims & Hers. MedMatch models can identify real-time treatments that may be best suited for a patients’ unique needs, the company added.
The new capability will help customers to take control of their health with deeper insights and enable providers to access a breadth of data and biomarkers that could help identify risk of disease before it develops, the company added. This in turn could facilitate more precise clinical decision-making.
Mainz Biomed has entered into a license and option agreement with Liquid Biosciences to access a portfolio of novel mRNA biomarkers for detecting pancreatic cancer with a blood test, Mainz announced recently.
The companies plan to develop this blood-based test for potential future Food and Drug Administration (FDA) applications.
Under the agreement, Mainz has the rights to develop the test using Liquid’s biomarkers through an exclusive license, with the unilateral option to acquire the exclusive global rights to the gene expression biomarkers.
These biomarkers have demonstrated a high degree of effectiveness in detecting pancreatic cancer. Coupled with Liquid’s proprietary algorithm, they have an overall sensitivity of 95% and specificity of 98% for the detection of pancreatic cancer, Mainz said.
The biomarker discovery process included multiple independent pancreatic cancer study cohorts. Using its proprietary Emerge platform, Liquid identified a panel of clinically relevant mRNA biomarkers from a blood-based cohort of 285 subjects, including 35 pancreatic cancer patients. Liquid further confirmed the biomarkers with two additional independent cohorts, confirming the strong clinical contribution of each biomarker shown in the initial discovery phase. Results will be replicated after integrating the biomarkers into a new product. It could potentially be a robust and accurate screening test for pancreatic cancer, Mainz said.
Mainz officials said the product could drive “a paradigm shift in how we can detect pancreatic cancer.” They added that the two companies plan to develop this pancreatic cancer screening test jointly. That process will include enhancement of commercial assays, refinement of algorithms, and preparation for potential FDA application and approval.
Savara recently announced the U.S. launch of its aPAP ClearPath Dried Blood Spot (DBS) Test in the United States.
Using a fingerprick blood sample, the DBS test helps diagnose pulmonary alveolar proteinosis (aPAP), a rare autoimmune lung disease caused by antibodies that target granulocyte-macrophage colony stimulating factor (GM-CSF) protein. The disease involves abnormal build-up of proteins and lipids in the lungs’ air sacs, causing impaired gas exchange. Clinical symptoms include shortness of breath, cough, fatigue, fever, chest pain, and coughing up blood. In the long-term, the disease can lead to serious complications, including lung fibrosis and the need for a lung transplant.
The DBS test has demonstrated a high correlation between levels of GM-CSF in dried and traditional serum samples and has achieved 100% analytical sensitivity in a cohort of individuals with confirmed GM-CSF autoantibody status, Savara said. Savara partnered with TrilliumBiO, which has a CLIA-certified lab, to develop and validate the test.
Savara officials said the test provides a convenient alternative to traditional venous blood draws. The test can help providers diagnose aPAP earlier and avoid misdiagnoses.
Neurogen Biomarking and Quanterix Corporation have announced an exclusive agreement to use antibody technology to measure a blood biomarker that serves as an early indicator of dementia and mild cognitive impairment (MCI) due to Alzheimer’s disease (AD).
The agreement gives Neurogen Biomarking exclusive rights to commercialize Quanterix’s ultrasensitive technology in direct-to-consumer testing in the United States, Europe, and Asia.
The partnership will leverage Quanterix’s antibody technology to detect phosphorylated tau217 (P-tau217). Specifically, Neurogen Biomarking will use this technology to develop a care platform that includes an at-home blood test that measures P-tau217. A robust body of literature shows that P-tau217 levels in blood correlate strongly with AD pathology and disease progression, supporting its use as a reliable biomarker, according to Neurogen Biomarking.
The company’s patient-initiated platform will also provide streamlined telehealth appointments with board-certified neurologists, offering health education and a complete Brain Health Plan with actionable next steps for personalized care.
Neurogen Biomarking expects to make its care platform commercially available in the second quarter of 2025 to people with memory and other cognitive challenges and people concerned about symptoms that may be associated with AD.