By Oleg Bess, M.D. bio I don't know about you, but I was stunned by the findings from a recent report published by Coverys, a national liability insurer, which I feel should put the entire … [Read more...]
GENETIC TESTING
FDA Authorizes First Direct-to-Consumer Genetic Test for Cancer Risk
March 27, 2018
The U.S. Food and Drug Administration (FDA) granted marketing authorization to 23andMe (Mountain View, Calif.) for its Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2—genetic … [Read more...]
INDUSTRY TRENDS
Next-Gen Sequencing, AI Driving Investor Interest in Diagnostics Sector
March 12, 2018
There is "intense" investor interest and "substantial" investment occurring in the next generation of diagnostics and tools companies (Dx/Tools), according to a year-end report … [Read more...]
TESTING TRENDS
Molecular Testing Increasingly Adopted for Skin Cancer Diagnosis
March 5, 2018
Dermatopathologists are increasingly using molecular testing for diagnosis of skin cancer samples. Yet, this adoption remains more concentrated in academic medical centers and high-volume clinical … [Read more...]
INDUSTRY TRENDS
Venture Capital Investment in Diagnostic Companies Strong in 2017
January 22, 2018
Venture capital investments in health care innovation reached an all time high in 2017, including in diagnostics/tools (Dx/Tools) companies, according to Silicon Valley Banks' preliminary 2018 … [Read more...]
TOP OF THE NEWS
LDTs, FDA-Approved Companion Diagnostics Perform Similarly; Off-Label Use of Companion Diagnostic Kits Common
January 8, 2018
One of the arguments for U.S. Food and Drug Administration oversight over laboratory-developed tests (LDTs) involves the need for greater assurances regarding the quality and consistency of these … [Read more...]
INDUSTRY TRENDS
FDA Continues Easing DTC, Home Use Test Regulations
January 2, 2018
In a continued reversal of its 2013 crackdown on direct-to-consumer (DTC) genetic tests, the U.S. Food and Drug Administration (FDA) unveiled loosened regulations in November that will effectively … [Read more...]
HEALTH CARE REFORM
High-Deductible Plans Tied to Reduced Use of Health Care, Including Diagnostic Testing
December 4, 2017
People enrolled in high-deductible health plans (HDHPs) cut their use of health services, including laboratory testing, according to a study published in the October issue of Health Affairs. HDHPs … [Read more...]
TOP OF THE NEWS
Malpractice Lawsuit Calls Out Lack of Genetic Counseling
December 4, 2017
A 36-year-old Oregon woman filed a $1.8 million medical malpractice lawsuit against her doctors and a southwest Oregon medical center for "negligent diagnosis and treatment" resulting from … [Read more...]
PAMA
CMS Ignores Flawed Processes, Finalizes 2018 PAMA Pricing; Labs Need to Take Immediate Action to Offset Impending Lean Times
December 4, 2017
By Kyle Fetter bio The final 2018 clinical laboratory fee schedule (CLFS) is out, and it is evident that the argument that the Centers for Medicare & Medicaid Services (CMS) PAMA … [Read more...]
