Weekly Enforcement Report: Drug Testing Fraud Dominates
Last week’s three key cases included two involving drug testing that was either medically unnecessary, or not provided at all.
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Proposed Rule Would Water Down CLIA Requirements for Lab Directors and Testing Personnel
While the rule has not yet been approved, if it is, nursing degrees would be considered the equivalent of biological science degrees.
Quest Expands into MRD Liquid Biopsy with Haystack Oncology Buy
The acquisition of the Johns Hopkins spin out and its liquid biopsy ctDNA test will significantly strengthen Quest’s oncology offerings.
Thermo and Symphogen Aim to Boost Biopharma Discovery
SAN JOSE, CA — On March 1, Thermo Fisher Scientific, the world leader in serving science, and Symphogen, an affiliate of and the antibody center of excellence within the international pharmaceutical company Servier, announce the continuation of their collaboration...
Cerba Research Unifies Quality Processes with Veeva Vault Quality Suite
BARCELONA, SPAIN — Veeva Systems announced March 1 that Cerba Research selected Veeva Vault Quality Suite to strengthen its laboratory and testing operations. With Vault Quality Suite, the company will advance quality for greater efficiency and compliance across...
Russian Invasion Means Labs Must Be on High Alert for Cyberattacks
Russia’s invasion of Ukraine may have a direct impact on your lab. The American Hospital Association (AHA) just issued a security alert warning hospitals and health systems to be on guard for Russian cyberattacks. The Russian military has previously used...
Study Details Proof-of-Concept for COVID-19 Detection via Saliva Screening
SANTA CLARA, CA — Agilent Technologies Inc. announced Feb. 23 that researchers from the QIMR Berghofer Medical Research Institute in Brisbane, Australia, collaborated with Agilent experts on a proof-of-concept FTIR-based saliva COVID-19 testing workflow using...
COVID-19 Infection Detected in Breath Tests
Traces of the SARS-CoV-2 coronavirus that causes COVID-19 can be detected in microscopically small fluid droplets exhaled during a very short time span. This is the finding of a new study from the University of Gothenburg. The measurement was carried out primarily...
US FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA®
CAMBRIDGE, MA — Foundation Medicine, Inc. announced on Feb. 21 that it received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic to identify patients with Microsatellite Instability High (MSI-H)...
Hematology Testing Solution Company Earns Key Grant
YOKNEAM ILLIT, ISRAEL — PixCell Medical, innovator of rapid hematology testing solutions at the point-of-care, announced on Feb. 22 that it has been awarded a grant by the International Health-Tech Pilot Program. PixCell will utilize this grant to develop and...
Patents Granted Relating to Urine Drug Screen Sample Validity Test Panels
BRANFORD, FL — Vision Diagnostics, Inc., DBA Validity Diagnostics (VDx), is a research-based developer and manufacturer of diagnostic products, announced Feb. 24 that the United States Patent and Trademark Office (USPTO) has issued two patents and VDx expects the...
Helping Patients with Cancer Better Manage Ocular Toxicities
CAMBRIDGE, MA — On Feb. 23, Voluntis, an Aptar Pharma company and leader in digital therapeutics, announced a partnership with Tilak Healthcare, a digital therapeutics company specializing in clinically validated medical mobile apps for chronic diseases. Under this...
Deep Learning Poised to Improve Breast Cancer Imaging
WASHINGTON, DC — Researchers have developed a new image reconstruction approach that could contribute to better breast cancer detection. The deep learning algorithm overcomes a major hurdle in multi-modality imaging by allowing images to be recovered in real time....
