West Coast technology companies competing for talent in a tight job market have begun offering novel health-related benefits, like overnight breast-milk shipping and elective egg freezing. … [Read more...]
TOP OF THE NEWS
Screening Blood Donations for Zika, Costly With Low Yields
May 22, 2018
Screening the entire U.S. blood supply for Zika virus may not be worth the $42 million price tag. Fifteen months of screening all donations to the American Red Cross yielded only nine Zika-positive … [Read more...]
TOP OF THE NEWS
CDC Receives Funding to Expand Laboratory Harmonization Efforts
May 7, 2018
The FY 2018 omnibus appropriations bill, passed by Congress in late March, included a little noticed provision that could ultimately bring significant changes to the laboratory industry—$2 million for … [Read more...]
TOP OF THE NEWS
Profound Discrepancies Seen Between DTC Genetic Results, Confirmatory Testing
April 30, 2018
Raw data from direct-to-consumer (DTC) genetic tests have an "alarmingly high" false-positive rate, according to a study published March 22 in Genetics in Medicine. Additionally, the study found that … [Read more...]
SAFETY
Diagnostic danger in the lab: Time to reform how we process orders
April 16, 2018
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...]
