Breath Sample Is Used by Opteev Technologies’ Combined COVID/Influenza/RSV Screening Device with 95% Sensitivity and 90% Specificity

Clinical laboratories and point-of-care settings may have a new diagnostic test if this novel handheld device and related technology is validated by clinical trials Efforts to develop breath analyzers that accurately identify viral infections, such as SARS-CoV-2 and Influenza, have been ongoing for years. The latest example is ViraWarn from Opteev Technologies in Baltimore, Maryland, and its success could lead to more follow-up PCR tests performed at clinical laboratories. ViraWarn is a...

Cambridge University Researchers Develop and Administer Lab-developed Red Blood Cells in Clinical Study with Promising Results for the Blood Supply

Sickle cell patients and others who need long-term blood transfusions provided by clinical laboratories and others would benefit most from successfully lab-grown blood Administering lab-developed red blood cells in humans in a clinical study conducted in the United Kingdom (UK) is being hailed as a significant step forward in efforts to supplement the supply of whole blood through the development of synthetic blood products. Of interest to those clinical laboratory managers overseeing hospital...

Hackensack Meridian Health and Hologic Tap Google Cloud’s New Medical Imaging Suite for Cancer Diagnostics

Google designed the suite to ease radiologists’ workload and enable easy and secure sharing of critical medical imaging; technology may eventually be adapted to pathologists’ workflow Clinical laboratory and pathology group leaders know that Google is doing extensive research and development in the field of cancer diagnostics. For several years, the Silicon Valley giant has been focused on digital imaging and the use of artificial intelligence (AI) algorithms and machine learning to detect...

Looming Government Shutdown Opens Door for Congress to Possibly Pass Clinical Laboratory Bills

Two former FDA commissioners who support changing oversight of laboratory-developed tests (LDTs) say FDA’s regulatory playbook is ‘outdated’ Congress’ attempts to avoid a government shutdown due to a lack of funding presents a final chance this year for two different clinical laboratory bills to be pushed through. The Verifying Accurate Leading-edge IVCT Development (VALID) Act and Saving Access to Laboratory Services Act (SALSA) could be added to a year-end spending package that will fund...

University College London Uses 3D Printers to Create Custom Prescriptions, What Does That Mean for Clinical Laboratories and Precision Medicine?

As 3D printing technology gains acceptance with pharmaceutical companies, clinical laboratories could see increased demand for pharmacogenomic testing Will physicians someday “print” prescription drugs for patients in-office? It sounds like science fiction, but research being conducted at the University College London (UCL) indicates the capability may be closer than we think, and it could bring about a new type of collaboration between clinical laboratories, ordering physicians, and...

Disgraced Theranos Founder Elizabeth Holmes to Serve 11 Years, Three Months in Prison, Ending the Latest Chapter in the Story of the Failed Clinical Laboratory Company

Judge will decide the restitution Holmes must pay to defrauded Theranos investors at future court date; Ex-COO Ramesh “Sunny” Balwani to be sentenced next month Clinical laboratory leaders and anatomic pathologists who closely followed the fraud trial of Elizabeth Holmes may have wondered how the Theranos founder and ex-CEO would be punished for her crimes. Now we know. On Friday, a federal court judge sentenced Holmes to 135 months—11.25 years—in prison in the culmination of her conviction on...
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