LabCorp | MedPath

Regeneron to Acquire 23andMe for $256 Million, Expanding Genetics-Driven Drug Discovery Capabilities

4 days ago

• Regeneron Pharmaceuticals has won the bankruptcy auction for 23andMe's assets with a $256 million bid, aiming to maintain the consumer genetics service while enhancing its drug discovery platform. • The acquisition includes 23andMe's Personal Genome Service, Total Health, Research Services, and Biobank assets, but excludes the Lemonaid Health business. • Regeneron has committed to prioritizing privacy and ethical use of customer data, working with a court-appointed Customer Privacy Ombudsman to ensure compliance with existing policies.

FDA Approves First At-Home Cervical Cancer Screening Test, Expanding Access to Preventive Care

13 days ago

• Teal Health's Teal Wand has received FDA approval as the first at-home cervical cancer screening test, offering an alternative to in-clinic pap smears for women aged 25-65 at average risk. • Clinical trials demonstrated the self-collected samples using the Teal Wand perform with 96% accuracy compared to clinician-collected samples, potentially addressing the issue that one in four women falls behind on cervical cancer screening. • The device, which works similarly to a tampon applicator, will be available for shipping starting in June in California before expanding nationwide, with the company working with major insurance providers on coverage options.

Hilo Secures $42 Million Series B Funding to Revolutionize Blood Pressure Monitoring

14 days ago

• Hilo (formerly Aktiia) has raised $42 million in Series B funding to advance its cuffless blood pressure monitoring technology, bringing total financing to over $100 million. • The funding round was co-led by Earlybird Health and Wellington Partners, with participation from new investors Kfund and naturalX Health Ventures, alongside existing investors including Khosla Ventures. • With 120,000 devices sold and regulatory approvals in multiple countries, Hilo aims to address the global hypertension crisis where only 20% of affected individuals have their blood pressure under control.

CND Life Sciences Secures $13.5M Series A Funding to Advance Skin-Based Neurodegenerative Disease Diagnostics

21 days ago

• CND Life Sciences has raised $13.5 million in Series A financing, with $8.6 million from its recent Series A3 round, to expand access to its Syn-One Test for detecting neurodegenerative diseases. • The Syn-One Test, which has demonstrated 95.5% sensitivity in a 2024 JAMA study, uses skin biopsy tissue to detect abnormal alpha-synuclein protein, a hallmark of Parkinson's disease and related disorders. • Under CEO Rick Morello's leadership since 2020, CND has processed over 35,000 tests adopted by nearly 3,000 neurologists across the U.S., positioning the company at a critical growth inflection point.

Novo Nordisk Launches NovoCare® Pharmacy, Offering Authentic Wegovy® at $499 Monthly

2 months ago

• Novo Nordisk has introduced NovoCare® Pharmacy, providing FDA-approved Wegovy® (semaglutide) at $499 per month for cash-paying patients, with convenient home delivery service. • The new service aims to combat the rising problem of counterfeit semaglutide products by offering reliable access to authentic medication in a once-weekly, single-dose pen format. • This initiative addresses affordability concerns for weight management medication while ensuring patients receive legitimate FDA-approved treatment amid growing demand for GLP-1 receptor agonists.

Labcorp Expands Precision Oncology Portfolio with Advanced Liquid Biopsy and MRD Testing Solutions

3 months ago

• Labcorp has launched Plasma Detect, a blood-based test using whole-genome sequencing to assess recurrence risk in stage III colon cancer patients by detecting circulating tumor DNA with high sensitivity. • The company has made PGDx elio plasma focus Dx commercially available, the first FDA-authorized kitted pan-solid tumor liquid biopsy test that enables hospitals to perform in-house genomic profiling with a 4-5 day turnaround time. • Labcorp Plasma Complete, a comprehensive 521-gene liquid biopsy test for advanced solid tumors, is now clinically available to guide personalized treatment decisions when tissue testing isn't feasible.

Fitusiran Shows Promise in Reducing Bleeding Episodes in Hemophilia A and B Patients

4 months ago

• Fitusiran, an RNA interference therapy, is highlighted as a potential breakthrough for hemophilia A and B treatment, regardless of inhibitor status. • Phase 3 trials (NCT03417245) demonstrated that fitusiran significantly reduced annualized bleeding rates in hemophilia A and B patients compared to on-demand factor concentrates. • Another study (NCT03417102) showed a 90.8% reduction in annualized bleeding rate in patients with inhibitors treated with fitusiran compared to on-demand treatment. • Fitusiran's efficacy and convenient subcutaneous administration position it as a drug to watch in hematology, offering a more personalized approach to hemophilia management.

Spear Bio and Beckman Coulter Receive FDA Breakthrough Device Designations for Alzheimer's Blood Tests

4 months ago

• Spear Bio's pTau 217 blood test received FDA Breakthrough Device Designation, offering a less invasive method for early Alzheimer's diagnosis. • Beckman Coulter's Access p-Tau217/β-Amyloid 1-42 plasma ratio test also gained FDA Breakthrough Device Designation, aiding in identifying amyloid pathology. • Both tests address the critical need for accessible, early Alzheimer's diagnosis, potentially improving patient outcomes and treatment access. • These designations expedite the development and review process, bringing innovative diagnostic tools to market faster for Alzheimer's disease.