CEO SUMMARY: Some executives at pharmacogenetic testing companies are criticizing the federal Food and Drug Administration for its recent actions to exercise oversight over PGx testing. But there is more to the story, said one expert who is a past adviser to the FDA on clinical laboratory testing. One issue is how to educate physicians
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A diagnostic test is any kind of medical test performed to aid in the diagnosis or detection of disease. For example, such a test may be used to confirm that a person is free from disease, or to fully diagnose a disease, including to sub-classify it regarding severity and susceptibility to treatment. Diagnostic tests help physicians make clinical decisions for patient care.
Some diagnostic tests are parts of a physical examination that require only simple tools in the hands of a skilled practitioner, and can be performed in an office environment. Some other tests require elaborate equipment used by medical technologists in clinical laboratories, or the use of a sterile operating theater environment.
Some tests require samples of tissue or body fluids to be sent off to a pathology lab for further analysis. Some simple chemical tests, such as urine pH, can be measured directly in the doctor’s office.
The validity of such test results produced in each laboratory is entirely dependent on the measures employed before, during, and after each assay. Consistency in the production of good results requires an overall program that includes quality assurance, quality control, and quality assessment.
Diagnostic tests can be classified into three categories: invasive, minimally invasive and non-invasive.
Every test that shows an association between test results and the target disease is potentially useful. If it is not on its own thought to be useful, then a combination of it with other test results and/or data can potentially lead to a post-test probability that is thought to be high enough to rule the diagnosis in or low enough to rule the diagnosis out.
Companion diagnostics have also been developed to preselect patients for specific treatments based on their own biology, where such targeted therapy may hold promise in personalized treatment of diseases such as cancer.
Growing acceptance of companion diagnostics is a trend with the potential to greatly increase the value that clinical pathology laboratory testing delivers to physicians, patients, and payers. It has become increasingly common for pharmaceutical companies to make agreements with in vitro diagnostics (IVD) manufacturers to develop a companion diagnostic test specifically for a therapeutic drug under development by that pharmaceutical company.
As most pathologists and clinical managers know, use of a companion diagnostic test is expected to add precision to the physician’s decision to prescribe therapeutic drugs.
Digital pathology is coming in a big way to two regions in two different nations. In the United Kingdom, it was announced on May 30 that the North Tees and Hartlepool NHS Foundation in the north of England signed a five-year contract with Sectra of Linköping, Sweden. Sectra is to deliver a “regional digital pathology solution” in
BeaconLBS announced a collaboration with MagnaCare of Garden City, N.Y., last month. The press release issued by the two companies stated that MagnaCare would use the “BeaconLBS Physician Decision Support (PDS) solution with its network of physician and laboratory providers.” MagnaCare describes itself as a company serving “Taft-Hartley funds, TPAs, carriers, and worker’s compensation and no-fault
Quest Diagnostics sold its clinical laboratory business in India last December, thus ending a 12-year effort to build a thriving business in that nation of 1.3 billion people. The buyer was Strand Life Sciences of Bengaluru, India. The transaction was announced in a press release issued by Quest Diagnostics and no purchase price was disclosed.
More than 63 healthcare and medical service organizations signed a letter asking officials at the federal Centers for Medicare and Medicaid Services (CMS) to reconsider their latest interpretation of a National Coverage Determination (NCD) on the subject of next-generation sequencing (NGS). Clinicalomics wrote that “the final NCD also included repeat testing when a new primary cancer
CEO SUMMARY: In the span of four days in September, Quest Diagnostics agreed to buy two lab companies and the lab testing service line of a third firm. In August, it purchased wellness company Provant Health, which had earlier filed a bankruptcy action. Each of these transactions helps Quest concentrate more on proprietary products and
DURING HER ADDRESS TO THE ANNUAL MEETING of the American Clinical Laboratory Association meeting in March, Rep. Diana DeGette (D-Colo.) explained why she and others in Congress had developed the Diagnostic Accuracy and Innovation Act (DAIA), a discussion draft that would give the FDA authority to regulate laboratory developed and in vitro diagnostic tests. At
CEO SUMMARY: Innovative clinical labs and pathology groups are absorbing this year’s Medicare Part B price cuts while continuing to pursue opportunities to add value. A common theme from many speakers at last week’s Executive War College in New Orleans is that the lab must get mastery of its LIS and informatics specifically to enable
IN PREPARED REMARKS at a clinical lab industry meeting last month, FDA Commissioner Scott Gottlieb, MD, outlined steps the federal Food and Drug Administration would take to reduce the regulatory burden on labs that develop next-generation gene sequencing and lab-developed tests. He also explained some of the ways that the agency could be more flexible
This is an excerpt from a 2,920-word article in the March 26, 2018, issue of THE DARK REPORT. The complete article is available for a limited time to all readers, and available at all times to paid members of the Dark Intelligence Group.
CEO SUMMARY: Here’s the first look for the lab industry at an important