TAG:

the laboratory

Truvian Sciences Raises $105M for Near-Patient Lab Test System

DESPITE THE PANDEMIC, investors continue to support emerging in vitro diagnostics (IVD) companies. This is particularly true of start-up companies that want to develop clinical lab testing systems that can be used at the point of care, that require small amounts of blood, and that deliver accu…

Read More



Memphis Path Lab Pivots to COVID, Pooled Testing

CEO SUMMARY: When routine testing volume declined sharply last winter and spring, one of the nation’s largest anatomic pathology groups added testing for COVID-19 and boosted revenue significantly. Since then, the laboratory has become the first in the nation to gain an Emergency …

Read More



New Twist: HHS Exerts Authority Over FDA on LDTs

CEO SUMMARY: In a recent memo, the federal Department of Health and Human Services’ general counsel rendered a legal opinion that FDA would need to issue new regulations to regulate LDTs. By stepping into this years-long dispute and saying that FDA cannot regulate LDTs through gui…

Read More



Amazon Targets COVID-19 Testing in its New Lab-Building Venture

This is an excerpt of a 1,980-word article in the August 3, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent COVID-19 t…

Read More



UHC Ready to Implement New Lab Test Registry

CEO SUMMARY: UnitedHealthcare announced that its new Test-Registry Protocol will become effective on Jan. 1, 2021, creating a major billing hurdle for labs and pathology groups. By that date, a lab must register each type of test before it can submit claims for these tests to the nati…

Read More



Amazon Building Labs to Do COVID-19 Testing

CEO SUMMARY: For pathologists and clinical lab directors, Amazon’s nascent lab-testing venture for employees could be a significant concern given that the e-commerce company could disrupt the clinical lab business nationwide. The online retail giant has long had an interest in medic…

Read More



Employers, Others Looking to Build New Clinical Labs

CEO SUMMARY: Employers, universities, municipalities, and other large organizations are interested in building their own clinical laboratories. In addition, entrepreneurs—many with no prior experience in laboratory medicine—want to make money providing COVID-19 testing. Many of th…

Read More



In Just 13 Days, Lab Buys, Validates & Uses Analyzer

CEO SUMMARY: In response to the nationwide outbreak of SARS-CoV-2, clinical labs are introducing new analyzers whenever possible to boost testing capacity. Pre-pandemic, buying and installing new instruments could take at least two months, and that timeline can go longer now. But beca…

Read More



Lab Directors Develop Plans for Return of Routine Hospital Care

CLINICAL LABORATORY DIRECTORS IN MICHIGAN are developing plans to test patients who will return when hospitals reopen for routine care. Included in those plans are strategies to do testing for the novel coronavirus on patients who will return for everyday care and elective procedures, said Bart…

Read More



Converting Paper Requisitions to Digital Cut Lab’s Costs

CEO SUMMARY: Health Network Laboratories cut costs and shortened lab test turnaround time by converting paper requisitions to digital data. It did so by scanning paper requisitions and having a vendor do the required data entry. This helped the lab reduce errors in its patient data. Using…

Read More



;