Weekly Enforcement Report: UDTs & Diagnostic Imaging
This week’s cases involved false billing allegations related to urine drug testing, as well as diagnostic imaging false claims and fraud.
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New Guidance Released for Cervical Cancer Detection
Recently released AACC document covers newly updated screening guidelines as well as information on surveillance and diagnosis.
Lab Business: It’s Back to Basics for LabCorp & Enzo Biochem
Enzo recently announced that it is selling its lab division to LabCorp for $146 million in cash.
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....
Element and Jumpcode Team Up to Boost Many Genomic Applications
SAN DIEGO, CA — Element Biosciences, Inc., developer of a new and disruptive DNA sequencing platform, today announced a collaboration and co-marketing partnership with Jumpcode Genomics that validates Jumpcode’s CRISPRclean technology on Element’s AVITI System. The...
Feds Target Fraudulent Billing of Genetic Cancer Tests
False ordering and billing of cancer genetic (CGx) tests has become a favorite target for federal fraud enforcers, with the U.S. Department of Justice (DOJ) reporting two notable convictions in the closing months of 2021. On Nov. 17, a 57-year-old former lab sales...
Healthy Growth Predicted for Global Aspiration & Biopsy Needles Market
According to a recently released report from market research company Research and Markets, the global aspiration and biopsy needles market is poised for solid growth over the next five years. The report valued the market at an estimated $879 million US for 2021 and...
Labcorp Completes Acquisition of Personal Genome Diagnostics
BURLINGTON, NC — Labcorp, a leading global life sciences company, announced Feb. 21 that it has closed its acquisition of Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics with a portfolio of comprehensive liquid biopsy and tissue-based products....
Startup Awarded NIH Grant to Develop Endometriosis Test
OAKLAND, CA — NextGen Jane, a genomics startup generating big data for novel applications in molecular diagnostics and drug development for female reproductive disorders, announced that it has received the green light for the second phase of a Small Business...
Beyond EUA: FDA Grants 510(k) Clearance for a COVID-19 Test
On Jan. 27, BioFire Defense's COVID-19 Test 2, an assay developed in collaboration with the U.S. Army, received 510(k) clearance from the FDA. Previously, the test had been cleared only for emergency use. And that’s a big deal. In fact, almost all of the more than...
