News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Best Practices in Molecular Assay Validation for Laboratory-Developed Tests

Best Practices in Molecular Assay Validation for Laboratory-Developed Tests

Seegene White Paper on Dark Daily website

Dark Daily’s free white paper, “Best Practices in Molecular Assay Validation for Laborator-Developed Tests,” is for the laboratory community and has been produced in partnership with Seegene USA. It is available for free download.

Molecular laboratory developed tests (LDTs) play a crucial role in providing accurate and timely patient care. These methods are designed to address those analytes or disease markers for which there is no commercially available test, so ensuring the safety and accuracy of these LDTs is not just an option – it’s a necessity.

This comprehensive white paper is designed to be your go-to guide, providing invaluable insights into critical success factors and essential functions crucial for maintaining compliance and delivering reliable results. Tailored for clinical molecular laboratory staff, this resource delves into the tangible aspects of compliant method validation, offering practical strategies for proving the accuracy and efficacy of laboratory-developed tests (LDTs).

Click here to download the free white paper. For additional information inquire at, or call Amanda Curtis at 512-264-7103.

Published February 15, 2024
Produced in partnership with

Seegene USA

Studies Show How Clinical Whole-Exome Sequencing May Forever Change the Future Practice of Medicine while Giving Pathologists a New Opportunity to Deliver Value

Similar study of exome sequencing at UCLA produces findings that mirror the diagnostic outcomes produced by researchers at the three Houston organizations

In recent years, pathologists and other clinical laboratory professionals have seen increasing evidence of the benefits of using exome sequencing for clinical diagnostic purposes.

Confirming their initial published findings of a 25% molecular diagnostic rate, researchers from Baylor College of Medicine (BCM), Baylor Human Genome Center, and the University of Texas Health Science Center at Houston have released results of a large sampling of 2,000 consecutive patients.

In this expanded study, published in the November 12, 2014, issue of the Journal of the American Medical Association (JAMA), 504 patients (25.2%) received a molecular diagnosis and 92 patients (4.6%) benefitted from medical intervention to ameliorate or eliminate negative symptoms. (more…)

In Boston this week, the Association of Pathology Chairs Looks at Healthcare’s Transformation and How It May Reshape Laboratory Medicine

Departments of pathology and clinical laboratory medicine at nation’s academic medical centers are uniquely positioned to deliver value—but only if they act in a timely fashion

DATELINE: BOSTON, MASSACHUSETTS—Today the Association of Pathology Chairs (APC) concluded its annual meeting, and transformation of the U.S. healthcare systems was front and center as the topic of primary interest. This transformation presents pathology departments at the nation’s academic centers with a range of unique opportunities, along with some serious challenges.

On the upside, academic departments of pathology and clinical laboratory medicine are well positioned to be the leaders in clinical diagnostics that utilize the latest genetic knowledge and incorporate state-of-the-art molecular technologies. Not only are they teaching this knew knowledge to the next generation of physicians and pathologists, they are often the only locally based laboratory organization in a city or region that offers these advanced medical laboratory testing services. (more…)

Johnson & Johnson Says It Is ‘Exploring All Options’ for Selling, or Spinning Off, Its Ortho Clinical Diagnostics Unit That Sells Clinical Laboratory Products

Any change of ownership in the fifth largest in vitro diagnostics company would represent a major development in the medical laboratory testing marketplace

Medical laboratory managers may see more consolidation in the in vitro diagnostics market if executives at Johnson & Johnson (NYSE: JNJ) decide to sell its Ortho Clinical Diagnostics (OCD) unit. This decision was announced earlier this week during J&J’s conference call to discuss its fourth quarter 2012 financial report.

Ortho Clinical Diagnostics is considered the fifth largest IVD company. Thus, any sale or spin-off of this $2 billion enterprise will be a significant development for the clinical laboratory and pathology testing industry. (more…)