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@Anna- Not sure if you subscribe to the WSJ, but they are running a fairly detailed article regarding the current state of testing. Following are selected excepts:
FDA to Allow Labs to Begin Use of High-Complexity Tests for Coronavirus- Policy means certain labs can begin immediate tests for coronavirus
The Food and Drug Administration said Saturday that it will allow hundreds of U.S academic hospital labs to immediately begin testing for the novel coronavirus. The move by the federal agency means that the nation will become able virtually overnight to test thousands of patients rather than the few hundred tested so far for the virus, known as Covid-19.
The FDA said the new policy is for certain laboratories that develop and begin to use validated Covid-19 diagnostics before the FDA has completed review of their Emergency Use Authorization requests.
The FDA estimated that between 300 and 400 academic medical centers and a few large community hospitals can immediately begin testing. Until Saturday’s announcement, the U.S. had been limited to a relatively few diagnostic tests done so far by the Centers for Disease Control and Prevention.
The FDA’s fast response to a rapidly evolving disease outbreak takes place even before it has been able to plow through the details of the hospitals’ emergency applications. In doing so, the FDA is tapping into a vast reservoir of diagnostic capability at American hospitals. The FDA said the guidance issued Saturday will enable laboratories to immediately use tests they developed and validated to achieve more rapid testing capacity in the U.S.
Among the sites with the largest volumes of test capability are the Mayo Clinic and the University of Utah. The Mayo Clinic, which didn’t immediately respond for comment, does about 30 million tests annually, including for patients whose lab samples are sent by air delivery from around the country and the world.
As a practical matter, the FDA action means that government medical officers should be able to quickly get a handle on the extent of infection from the Covid19 virus.
The laboratory tests at hospitals are generally known as lab-developed tests, and they fall into a gray area of the FDA regulatory world. The agency has long noted that there have been cases of inaccuracies that the FDA would like to catch before they affect patients. But those cases generally have involved a handful of for-profit entities, and not the academic hospitals covered by the current action.
The academic labs say that their ability to move quickly allows them to be on top of changes in, for example, genetic types of diseases and patients. They say that enables them to get the right therapies to patients far more quickly than would be possible if new tests all had to go through the FDA approval process before being used.
Even the most accurate of medical tests have a small rate of false positive results, as well as false negatives. So a test can either miss a case, or incorrectly say that a patient has the disease. Since there now is no therapy specific to the coronavirus, that will matter less for specific treatment than for how patients are isolated to keep them separated from people who are healthy.
@Old_Joe Thanks for the info. No, I don't subscribe to WSJ. This tells me that the newness of many of the assays may mean that there is a need for more data before specificity and false alarm rates are locked down. In our state the original victims' contact with the virus is being reported as unclear.
large rebounds, ...was ?! corrections past few wks... media maybe blowing lots stuff out of proportions though...only few deaths in US so far but too early to tell [much less than seasonal flu/ or streptococcus infections related deaths]
Frankly I think FD is on the right course (at least for him) and I don't think we've seen the worst of it (selling) yet. If you're a long term investor such corrections are to be expected and I wouldn't do anything. If you're short term the last weeks events should demonstrate which if any of your positions are the riskiest and cause you to consider of you want to deal with that anymore. If not then use up days like today to reposition your assets. Just my opinion.
Comments
FDA to Allow Labs to Begin Use of High-Complexity Tests for Coronavirus-
Policy means certain labs can begin immediate tests for coronavirus
Thanks for the info. No, I don't subscribe to WSJ. This tells me that the newness of many of the assays may mean that there is a need for more data before specificity and false alarm rates are locked down. In our state the original victims' contact with the virus is being reported as unclear.
Derf