CEO SUMMARY: With each passing month, Theranos is looking more like a traditional clinical laboratory company, based on how it is expanding its patient service center network and courier/logistics system into different regions while pursuing managed care contracts with health insurers. Meanwhile, respected laboratory scientists and physicians are using peer-reviewed medical journals to point out that Theranos has yet to publish details about the performance of its diagnostic technology to enable independent validation.
Tag: clia laboratory
CEO SUMMARY: Over the past 18 months, Theranos has taken steps to enter the clinical lab marketplace. Across Greater Phoenix, Theranos now has specimen collection centers in about 40 Walgreens pharmacies. It is opening a CLIA lab facility in Scottsdale. Now that it is delivering clinical laboratory testing services on a regular basis, the quality of its laboratory test results and the service it provides to physicians and patients will get close scrutiny from both investors and competing labs.
CEO SUMMARY: PerkinElmer is the latest U.S. organization to open a clinical laboratory business in China. Last December, it formally opened its new Suzhou PerkinElmer Medical Laboratory. The new lab is located about 60 kilometers (37 miles) west of Shanghai. It will provide neonatal and prenatal screening along with infectious disease testing. PE’s new venture hopes to leverage relationships developed from providing newborn and prenatal screening in China throughout for the past 20 years.
I read your two articles on Theranos in the August 11 issue of THE DARK REPORT, and concur in large part with your thoughtful conclusions.
For several years, I have closely followed Theranos and have been quoted in trade publications speaking favorably on Theranos and its relationship with Walgreens. Originally, I was attracted to the
In recent years, a series of decisions involving molecular diagnostics tests made by Medicare officials and the Medicare Administrative Contractors (MACs) have caused much disruption in the clinical laboratory industry. In response to these developments, on April 16, the California Clinical Laboratory Association (CCLA) and a Medicare beneficiary filed a lawsuit against the U.S. Department
CEO SUMMARY: Federal regulators rely on interpretations from administrative law judges (ALJ) for guidance in how to apply the Clinical Laboratory Improvement Amendments (CLIA) as they pertain to proficiency testing (PT) and the issue of inadvertent PT referrals. Representatives of the Centers for Medicare & Medicaid Services (CMS) and the College of American Pathologists (CAP)
THERE’S A REGULATORY TRAP awaiting the unwary laboratory organization. It involves language in CLIA rules for proficiency testing (PT). All medical directors and lab administrators will want to fully understand the implications of what appears to be an emerging trend in CLIA laboratory enforcement.
In recent years, an ever-greater number of labs have unwittingly found themselves
CEO SUMMARY: Here’s a deal that is all about proprietary molecular assays and access to new markets. With its purchase of RedPath Integrated Pathology, ExonHit Therapeutics, S.A., of Paris, France, gains a CLIA laboratory and access to the U.S. market, even as the new owner opens the door to the European market for RedPath. As
EFFORTS ARE UNDER WAY TO REVIEW existing requirements for laboratory certification under the federal Clinical Laboratory Improvement Act (CLIA). CLIA legislation was a response by Congress to widely-publicized failings in the quality and performance of certain cytology and office laboratories during the 1980s. It has been 16 years since the existing requirements took effect.
CEO SUMMARY: It was six years ago when Geisinger Health System pushed laboratory testing and pharmacy services closer to the patients and referring physicians. By establishing coagulation clinics in six multi-specialty clinic sites, Geisinger has allowed pharmacists to use point-of-care testing to provide coag consults, therapy, and patient counseling in real time–often in as little as 30 minutes