Top-5 Diagnostics Trends Identified by Kalorama Will Impact In Vitro Diagnostics Manufacturers, Medical Laboratories in 2017

Report states IVD companies are focusing on core lab, seeking China FDA approval, and targeting urgent care Several of the same powerful trends reshaping healthcare and clinical laboratory services are having equally significant influence on in vitro diagnostics (IVD) manufacturers. In particular, the consolidation of hospitals and physicians, as well as the emergence of new sites of service—such as urgent care centers and retail clinics—are motivating IVD companies to tailor new diagnostic...

UCLA Researchers Develop Lens-Free Smartphone Microscope, Pathologists May Be Able to Take the Clinical Pathology Laboratory Just About Anywhere

In a trial, the lens-free microscope invention from the UCLA California Nano Systems Institute enabled a board-certified pathologist to detect cancers and other cellular abnormalities at 99% accuracy One of our favorite innovators is at it again, this time with a device that could eventually allow pathologists to use a device coupled with a smartphone to view cancer and other abnormalities at the cellular level. At UCLA, Professor Aydogan Ozcan, Ph.D. is already well known for having invented...

Genomic Study Reveals Role of Human Papillomavirus in Cervical Cancer and Identifies Novel Therapeutic Targets for the Disease

Findings may help physicians tailor cervical cancer therapies to specific gene mutations and improve the accuracy of diagnostic screening tests for this disease New scientific knowledge about the role of human papillomavirus (HPV) in the growth of cervical cancer is creating excitement within the medical community. Among other things, these findings could encourage more widespread vaccination against HPV. That in turn would lead to reduced Pap smear testing by pathology laboratories over time....

Agreement on Use of Genetic Information from 61-Year-Old Cervical Cancer Cells Sets New Ethical Privacy Standards for Clinical Pathology Laboratories

Family of Henrietta Lacks, who died in 1951, will have a say in the research use of the  HeLA cancer cells Patient privacy rights involving genetic information has gone to a new level. Pathologists and clinical laboratory managers will want to understand the legal precedents and new standards established in an unprecedented agreement between the family of a woman who died in 1951 and the growing research establishment studying her cervical cancer cells following her death. It is a human...

LabCorp Stops Selling OvaSure Ovarian Cancer Test after FDA Letter

Facing pressure by the Food and Drug Administration over its OvaSure test for ovarian cancer, Laboratory Corporation of America announced last Friday in a Securities and Exchange Commission filing that it had stopped sales of the test. The dispute between the FDA  and the nation’s second largest laboratory company will be closely watched for insights into how the FDA regulates “home brew” assays. In the October 20, 2008 issue of The Dark Report, an intelligence briefing...