Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
LifeCode Obtains CAP Laboratory Accreditation Raises $20.5 Million
By Ron Shinkman, Editor, Laboratory Industry Report LifeCode, the California-based laboratory firm that focuses on next-generation sequencing assays, has obtained laboratory accreditation from the College of American Pathologists and raised $20.5 million from a...
Claritas Genomics Raises $15 Million to Expand Operations, Test Menu
By Stephanie Murg, Managing Director, G2 Intelligence Genetic diagnostic testing company Claritas Genomics (Cambridge, Mass.) has secured $15 million to fund expansion of its commercial operations and launch novel next generation sequencing-based tests for...
Human Longevity Licenses Assays, Platform from Personal Genome Diagnostics
By Ron Shinkman, Editor, Laboratory Industry Report Human Longevity, Inc., a California-based genomic laboratory, has entered into an agreement with Personal Genomic Diagnostics, Inc. to license the latter's products to expand its ability to analyze cancer genomes....
HHS Secretary Calls for Bi-Partisan Efforts to Improve Health Care
By Kelly A. Briganti, JD, Editorial Director, G2 Intelligence Health and Human Services Secretary Sylvia Matthews Burwell recently delivered a speech to the New America Foundation calling for Congress and the Administration to work together to capitalize on...
Medicare Fee-For-Service is Top of List for Fraud, Waste and Abuse
By Christopher P. Young, Editor, G2 Compliance Advisor Medicare fee-for-service (FFS) tops a list of 13 high error rate government programs estimated to have lost $106 billion during fiscal year 2013 to improper payments. According to the authors of a study by...
Obama Touts Precision Medicine Initiative in State of the Union
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies President Barack Obama announced a new precision medicine initiative this week in his State of the Union Address. Also known as personalized medicine, expanding the government's focus on...
DNA-Based HPV Test OK For Primary Screening
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies DNA-based human papillomavirus tests can be used as a primary screening tool for cervical cancer in women 25 years of age and older, according to a controversial interim guidance published...
Cleveland HeartLab Acquires Proprietary Cardiac Risk Algorithm Technology
By Ron Shinkman, Editor, Laboratory Industry Report The Ohio-based Cleveland HeartLab (CHL) has acquired technology developed by Stanford University that can more accurately predict the likelihood of heart attacks. Known as MIRISK, its nucleus is an algorithm that...
Roche to Take Majority Stake in Foundation Medicine
By Stephanie Murg, Managing Director, G2 Intelligence Roche is betting big on cancer genomics. The Swiss pharmaceutical giant has agreed to acquire a majority stake in Foundation Medicine (Cambridge, Mass.), which uses genetic sequencing to optimize treatment...
Pharmaceutical Company Uses Speaker Fees To Provide Kickbacks
By Christopher P. Young, Editor, G2 Compliance Advisor Pharmaceutical company Daiichi Sankyo Inc. paid $39 million and agreed to enter into a five-year Corporate Integrity Agreement to settle government allegations of using speaker fees and lavish dinners as a...