GlaxoSmithKline to Use a ‘Breath Biopsy’ Test by Owlstone Medical in a Phase II Clinical Trial of a Respiratory Drug

It has been regularly demonstrated in recent decades that human breath contains elements that could be incorporated into clinical laboratory tests, so the decision to use this “breath biopsy” test in a therapeutic drug trial will be closely watched When a major pharma company pays attention to a breath test, implications for clinical laboratories are often forthcoming. Such may be the case with GlaxoSmithKline (GSK). The global healthcare company has selected Owlstone Medical’s Breath Biopsy...

Federal Regulators Issue Notice to DTC Test Company Orig3n That Its Purchase of Interleukin Genetics Could Involve CLIA Compliance Issues

CMS sends letter to Orig3n notifying the genetic test company that it may not have the required certifications to market its genetic tests Orig3n’s recent ill-fated “DNA Day” promotion to offer free genetic tests during an NFL football game this past fall pushed Orig3n into the media spotlight. The Massachusetts-based biotech company—which sells 18 different DNA tests on its website—suspended the promotion due to questions from the Centers for Medicare and Medicaid Services (CMS) and the...

Blockchain Technology Could Impact How Clinical Laboratories and Pathology Groups Exchange Lab Test Data

Insurers might use blockchain technology to enable instantaneous verification and interoperability of healthcare records, which could impact clinical laboratory payment systems Medical laboratories and anatomic pathology groups are keenly aware that connected, secure, interoperable health records are critical to smooth, efficient workflows. However, the current often dysfunctional state of health information technology (HIT) in America’s healthcare system often disrupts the security and...

Diagnostics Marketing Association’s (DxMA’s) Global Marketing Summit Will Convene in New Orleans Just Prior to the Executive War College (EWC) to Discuss Primary Trends Facing IVD Manufacturers, Clinical Laboratories

The DxMA Summit’s agenda will complement EWC’s and will explore disruptive technologies likely to be of great interest to medical laboratory leaders and pathology groups Cybersecurity, wearable technology, and social media are the primary trends facing in vitro diagnostics (IVD) manufacturers and clinical laboratories. That’s according to Debra Harrsch, President-elect of the Diagnostics Marketing Association (DxMA), a self-funded organization devoted to helping diagnostic marketing...

New 3D Sutures Enable Collection of Biodata In Vivo Using Thread-Based Diagnostic Devices

Engineers have designed a microfluidics and nano-scale diagnostic toolkit suitable for attaching directly to muscle and tissue to monitor biomarkers and stream results wirelessly to care providers and medical laboratories What would change in medicine if physicians had sutures that could collect and report biomarker data, including the kinds of biomarkers that are used in clinical laboratory tests? Such a product may be feasible, based on newly-published research. “Smart sutures” are a joint...