Sandy, Utah-based Sure Genomics is the latest genetic testing company to get a letter from the Food and Drug Administration asking why the company is marketing its SureDNA genetic testing kit to consumers without first obtaining clearance from the federal agency. The FDA sent the letter to Sure Genomics earlier this month and noted that the
CEO SUMMARY: When pathology labs discover instances of a misidentified or contaminated tissue specimen, there is a new service that allows them to retrospectively use DNA to properly match that specimen to the correct patient. In part two of our series, we look at how some pathology labs are using the Know Error service to
CEO SUMMARY: Prevention of diagnostic testing errors is getting more attention by both physicians and pathology labs because patients are less tolerant of potentially life-changing errors. Strand Diagnostics’ Know Error system is designed to reduce or eliminate errors involving tissue specimen misidentification. In this first part of our two-part series, we provide information about the
CEO SUMMARY: One intrepid medical technologist has spent almost two decades in volunteer service working in the clinical laboratories of hospital ships operated by Mercy Ships International. As the world’s largest hospital ship, the Africa Mercy contains six operating rooms, a 78-bed ICU and patient ward, along with a clinical lab that is equipped with
Expanded genetic testing for cancer patients in the United Kingdom is one goal of a new effort by the Stratified Medicine Programme at Cancer Research UK. Officials want to ensure that the right genetic tests are available to support use of new therapeutic drugs for different types of cancer. The project will start in Wales
In response to continuing requests by clients and readers of THE DARK REPORT, this issue institutes a new feature titled “Lab Fraud Watch.” It will provide information about activities in the medical laboratory testing marketplace which could be interpreted as violating federal and state fraud and abuse laws.
DIGENE ENJOYS GROWTH OF 39% IN RECENT MONTHS
FUELED BY RECOGNITION that HPV plays a key role in causing cervical cancer, demand for Digene Corporation’s hc2 High-Risk HPV DNA test is increasing at impressive rates.
For fiscal third quarter 2004, Digene reported revenue growth of 39% over the same quarter last year. Its revenues climbed from $17.0
CEO SUMMARY: Because cervical cancer screening involves more than 55 million Pap tests per year in the United States, it is a high-profile segment of the lab testing industry. HPV testing is making steady inroads into the cervical cancer screening process. Digene Corporation is the direct beneficiary of this, but Cytyc Corporation and TriPath Imaging