Foundation Medicine Inc.'s pan-cancer detection test has received a nod from the FDA, making it one of the most comprehensive companion diagnostics to receive approval from the agency. Concurrent with FDA approval, the Centers for Medicare and Medicaid Services issued a preliminary National Coverage Determination (NCD) for the Foundationone Cdx.
So what were the major talking points coming out of Cleveland Clinic's Medical Innovation Summit? It certainly wasn't a discussion on the lack of venture capital dollars available for med-tech start-ups - a topic that used to dominate conversations a few years back. Nor was it about the Affordable Care Act. No, the major talk at this year's Medical Innovation Summit, which was held last week, revolved around companion diagnostics. Look for new and exciting pharmaceuticals to be married to diagnostic tests for the foreseeable future. It seems in nearly every other panel something about combination diagnostics was mentioned. One...
A few years back my brother-in-law Sam was starting a new job and was required to get a physical as part of the hiring process. A standard X-ray revealed a spot on his lungs and further testing confirmed it was cancer. The diagnosis came about two years after he’d quit smoking, but he had been a smoker for many years and was somewhere in his early 40s. Thankfully, because it was caught and treated so early, he is still with us today and doing great. But what if he hadn't had that physical? Earlier this week the U.S. Preventive Services...
How many of us have ever gone into the doctor to undergo some tests and then have to wait several days to get the results? Is it just me or can the wait be a bit maddening? I mean in all that time, the thoughts that can run through your head are overwhelming right? In a society where things are increasingly speeding up, it's incredible that there isn't a stronger push for making patients aware of their test results much earlier. One med-tech company is focused on developing tests that could garner rapid results for patients, and quite possibly eliminate...
If I had to describe Jamar Rogers in just one word it would be life. More than anyone else I have ever met or spoken with, Jamar Rogers is full of life. It was evident from the first time I saw him on the second season of NBC’s The Voice and it was reconfirmed last week when I spoke with him on the phone, that this is a guy who is truly living his best life. Jamar’s spirit and energy and courage shines through everything he does, on stage and off. One of the things that have allowed him to...
OK, I admit it, I love to sleep! If I need any more reminders that I am getting old – thinning hairline, constant aches and pains, the imminent arrival of reading glasses – the fact that I really enjoy going to bed early should be a sign. To me, nothing is more relaxing than a good book and some peace and quiet before nodding off; 10:00 is usually about right. Accompanying me on the bedside table is a sound machine which creates soothing background noise to help drown out the...
Remember when expectant parents would go around showing off their ultrasound pictures to 350 or more of their family, friends, co-workers, neighbors, and old classmates? Neither do I. Yet on any given day I can see 3-D ultrasound pictures posted by Facebook friends I only vaguely remember from school. Awe, it’s a picture of your uterus, you shouldn't have. No, really, you shouldn't have! Socially speaking, this trend is downright disturbing, especially when the mother-to-be makes it her profile picture. Now her fetus is available for the entire world to...
If someone would have asked me three years ago what Necrotizing enterocolitis (or NEC for short) meant, then my response would probably be a blank stare, followed by I'll have to get back to you on that. That's often the reply I give to people when I'm not sure of an answer. But if someone were to ask me today what NEC means, the answer would probably be a bit different. I think the first thing I'd say is, "Well how much time do you have for me to answer that question honestly?" For simplicity's sake, we can just say...
It’s doubtful that Britney Spears’ 12-year-old hit single, Oops! . . . I did it again, entered into Roche’s mind when the firm disclosed a hostile takeover bid to acquire Illumina late last month for $44.50 a share in cash, or about $5.7 billion. Okay, maybe doubtful isn’t the right word. Maybe I should say that there was no chance in the world that Roche even considered this song when describing its takeover bid. But to those who have followed Roche closely throughout the past few years, the song seems to fit Roche’s attempts to acquire the DNA sequencing company...
Screening for various diseases is controversial these days thanks to the U.S. Public Services Task Force and similar agencies in other nations, which have suggested a more cautious approach to screening. These suggestions have been blasted by doctors and patient groups for obvious reasons. Former Medical Device Daily executive editor Jim Stommen took up prostate cancer screening in a posting at this blog a few weeks back, and while I agree with Jim on a lot of things, I felt one perspective was missing; that of the federal budget. The problem is that no national economy can support indiscriminate...
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