How One Company’s Saliva Spit Tubes Dominate the DNA Collection Device Market by Maintaining Specimen Integrity for as Long as Two Years

From point-of-care diagnostic tests to ancestral DNA home-testing, this company’s spit tubes are used by more medical laboratories than any other brand Most clinical laboratory specialists know that OraSure Technologies of Bethlehem, Pa., was the first company to develop a rapid point-of-care DNA diagnostic test for HIV back in the 1990s. This was a big deal. It meant physicians could test patients during office visits and receive the results while the patients were still in the office. Since...

23andMe Socked with FDA Warning Letter and Class Action Lawsuit over Company’s Genetic Testing Services

FDA’s assertion of power to regulate genetic tests is a familiar argument to pathologists and clinical laboratory scientists, but does create problems for 23andMe It has been national news since November 22, when the Food and Drug Administration (FDA) sent a letter to 23andMe ordering it to stop the sale of direct-to-consumer genetic tests. The FDA said that 23andMe had failed to prove the validity of its genetic tests and gave the company 15 days to respond and  identify the steps it would...

Changing Reimbursement for Clinical Pathology Laboratory Testing and Direct-to-Consumer Testing Discussed at California Clinical Laboratory Association Conference in San Diego

The end of fee-for-service payments has huge implications for U.S. medical laboratories and anatomic pathology practices SAN DIEGO, CALIFORNIA—In the American healthcare system today, the era of fee-for-service medicine will soon end. This development has huge implications for every clinical laboratory and anatomic pathology practice in the United States because fee-for-service is their primary source of revenue. This week at the 2013 Annual Conference of the California Clinical Laboratory...

Scripps Researchers Study Consumer Response to Results of Predictive Genetic Tests

Pathologists likely to be surprised to learn that consumers reach objectively to the results of genetic tests How consumers will react to the results of genetic tests is a subject of constant debate by many health policy wonks. This same debate has its counterpart in the clinical laboratory testing industry, as pathologists and PhDs discuss the pros and cons of allowing consumers to order their own predictive genetic tests and molecular diagnostic assays. Rapid developments in whole human...

Many Genetic Tests Offered to Consumers Over the Internet are Misleading and of No Practical Use

GAO Gives Congress a Poor Report on Direct-to-Consumer Genetic Tests Sold by Web-Based Companies According to the Wall Street Journal, Direct-to-consumer (DTC) genetic tests from the four companies 23andMe, Navigenics, deCODE genetics, and Pathway Genomics Corp, are generating results “that are misleading and of little or no practical use.”  This was the finding of the U.S. General Accounting Office (GAO) in its recently released report. Pathologists and clinical laboratory managers will be...
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