Dec 11, 2013 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory News, Laboratory Pathology, Laboratory Sales and Marketing, Management & Operations
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 take to address FDA concerns.
This event has fulfilled the predictions of many pathologists and clinical laboratory professionals. Having dealt with the FDA throughout their careers, experienced medical laboratory scientists knew that the FDA would eventually take enforcement action against 23andMe, if the company did not provide adequate scientific information to support the clinical validity of its genetic tests. (more…)
Nov 27, 2013 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
A new approach to genetic testing of critically ill children, developed by researchers at Children’s Mercy Hospital, can be a road map other medical laboratories can follow
In Kansas City, a medical team at Children’s Mercy Hospital has demonstrated that rapid whole human genome sequencing, when combined with interpretative software, can return clinically actionable answers quickly enough to be of value to physicians who are diagnosing patients showing symptoms of genetic conditions.
As many pathologists and clinical laboratory managers know, childrens’ hospitals across the nation are often at the vanguard of using molecular diagnostics and genetic tests to guide diagnosis and treatment of pediatric patients. Having the capability to make fast and accurate diagnoses of genetic conditions gives physicians at these institutions the ability to significantly improve the outcomes of their patients.
A report published by Medpagetoday.com reported the findings of researchers at Children’s Mercy Hospital. (more…)
Nov 11, 2013 | Digital Pathology, Instruments & Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
The Center brings together scientists from around the city to translate promising research into medical innovations to treat, prevent and manage disease
Gene sequencing is going big time in the Big Apple. Last month the New York Genome Center (NYGC) moved into a state-of-the-art, 170,000-square-foot genome sequencing and biometrics research building. New York City is putting down its marker to claim a leading role in advancing genetic knowledge.
What makes this development notable for the clinical laboratory industry and the anatomic pathology profession is the fact that cities across the nation are investing substantial amounts of capital to create their own genetic and biotech research and development hubs. Their common objective is to bring together all the expertise, financial support, and business acumen needed to create a job-creating critical mass in the fields of biotech and genetic medicine. (more…)
Nov 6, 2013 | Coding, Billing, and Collections, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Pathology, Management & Operations
Medical laboratories could benefit by fewer customers for U.S tissue diagnostics products
Even as anatomic pathology laboratories in the United States see a decline in reimbursement for many pathology testing services, the demand for tissue diagnostics products will continue to be robust in coming years. There are at least three reasons why this will be true.
Research analysts at Frost & Sullivan predict that global sales of tissue diagnostics products will grow from $2.4 billion in 2012 to $3.5 billion by 2017. They attribute this to the increased use of anatomic laboratory automation.
These predictions were made in a new report issued by Frost & Sullivan. About 79% of the global tissue processing market is in the United States and Europe. (more…)
Oct 4, 2013 | Coding, Billing, and Collections, Digital Pathology, Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory Pathology
Complaints are rolling in about the high-cost interface fees charged by EHR companies for federally mandated connections
It won’t surprise pathologists and clinical laboratory managers to learn that vendors of electronic health record (EHR) systems are milking physicians and other health-care providers with excessive fees above and beyond the EHR cost. Vendors are socking it to providers—including medical laboratories—in the pricing they charge to create the mandatory interfaces required for the EHRs to connect with outside networks.
These excessive fees were the subject of a story published by Modern Healthcare. It reported that healthcare providers contend that the interface fees are excessive because the software developed for federally mandated connections are common to all vendor customers. Therefore, the interfaces are used over and over again. (more…)
Sep 13, 2013 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations, News From Dark Daily
Across the nation, resources to support medical laboratory testing are dwindling even as physicians order more tests and labs must spend to acquire new diagnostic technologies
Canada’s clinical laboratory testing marketplace has just undergone another wave of consolidation among independent medical laboratory companies that has eliminated major lab test providers in the provinces of Ontario and British Columbia.
But that’s just one trend in a nation where successive budget-cutting initiatives continue to whittle down and shrink the nation’s clinical laboratory testing infrastructure.
(more…)
