Jul 11, 2016 | Coding, Billing, and Collections, Compliance, Legal, and Malpractice, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
The National Institute of Health’s ClinVar public database of genetic variation is demonstrating good accuracy, and a handful of clinical labs are learning to share and review this relatively small genetic database
In the analysis of genomic variants, data sharing is proving to be an important tool for researchers, scientists, pathologists, and clinical laboratory scientists.
Accessible databases like ClinVar, which was launched by the National Institute of Health (NIH) in 2013, have emerged to aggregate genetic sequencing with acceptable results. ClinVar exists to meet the needs of the medical genetics community. It collaborates with organizations to make pertinent genetic information available.
ClinVar is an archive of compiled data relating to genotype and phenotype variations among humans. Through this database, individuals can present and peruse submissions regarding variants found in patient samples.
ClinVar is averaging about 6,000 submissions per month by both commercial laboratory companies and reference labs. Major contributors to the database include: (more…)
Apr 15, 2016 | Coding, Billing, and Collections, Instruments & Equipment, Laboratory Pathology, Laboratory Testing
Filing a complaint with the Louisville division of the District Court for the Western District of Kentucky, Exact Sciences seeks payment from Humana for at least 4,664 Cologuard tests as well as coverage for the procedure in the commercial plans offered in mandate states
Citing more than $800,000 in unpaid service fees and damages, the Exact v Humana lawsuit is the latest example of the on-going struggle between health insurers and clinical laboratories offering proprietary and patent-protected lab procedures.
Exact Sciences Corp. (NASDAQ: EXAS), and Exact Sciences Laboratories, LLC (Exact) allege that Humana (NYSE: HUM) has denied 120 claims in Kentucky worth approximately $70,000 as well as 293 additional claims in other states with coverage mandates worth approximately $169,000.
Exact claims that attempts to appeal denied claims resulted in payment for some services but that more than half remain rejected. They also report roughly 350 claims in which Humana underpaid.
They are seeking full payment for all claims made since the start of 2014 in Kentucky, Georgia, Missouri, North Carolina, Texas, Illinois, Nevada, and Oklahoma. (more…)
Jul 2, 2014 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
Exogen uses crowdfunding to both collect needed specimens and raise capital to pursue FDA clearance for its proposed medical laboratory test that would identify an individual’s damaged DNA
It might be coming soon to a pharmacy or other retail store near you: a medical laboratory test kit allows consumers to test themselves for damaged DNA. This bold new world for genetic testing is the vision of a new company in San Francisco called Exogen Biotechnology.
This startup business was co-founded by Sylvain Costes, Ph.D., a nuclear engineer who serves as Exogen’s Chief Executive Officer, and Jonathan Tang, Ph.D., a bioengineer. Their team is developing a blood test that will enable consumers to monitor their own DNA damage and take actions to reverse the damage. (more…)
Mar 5, 2014 | Laboratory Hiring & Human Resources, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Management & Operations
Pathology groups and clinical laboratories are among the beneficiaries if the Accelerating Medicines Partnership achieves its goals
Power players in healthcare are about to invest nearly a quarter of a billion dollars to accelerate the time it takes for new medical discoveries to gain regulatory approval and enter clinical use. The emphasis will be on both therapeutic drugs and diagnostics, making this an important development for in vitro diagnostics companies and medical laboratories.
Anchors to this new initiative are the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). Their partners are 10 pharmaceutical companies and six nonprofit groups. The goal is to jumpstart research to find targets for new drugs and diagnostics, noted a Genomeweb.com article. (more…)
Aug 16, 2013 | Compliance, Legal, and Malpractice, Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Pathology
Pathology groups and clinical laboratories gain the benefits of increased connectivity, greater productivity, and a tool to reduce costs
Acceptance of digital pathology systems is growing steadily in both North America and Europe. One sign of this acceptance is the rapid increase in the purchase of digital pathology systems by anatomic pathology laboratories in these regions.
In fact, one consulting company says that the digital pathology market is poised to explode over the next seven to eight years. This will happen as medical laboratories acquire and deploy digital pathology systems to improve their connectivity with other providers, to improve productivity of pathologists, and as a tool to reduce costs. (more…)
