As someone who had HPV, I'd really be interested in something like this since the current system fails me as a male and refuses to test or tell me anything about it. It'd be a positive for my partners if I could tell them that I have HPV but the current vaccine prevents the strains I have, however, at the moment, I just have no idea. In the end I think American Males should be vaccinated as well. (Well males everywhere but currently I'm American so that's where my train of thought is).
Physician-scientist here. Current recs from the American Academy of Pediatrics is for both males and females to be immunized for HPV prior to initiation of sexual activity (1). Initially I do believe that the recommendation was only for girls but that has changed for two major reasons: increase herd immunity in the overall population and because men can also get malignancies and lesions from HPV. Of note, the vaccine does not prevent all HPV infections. The 4-valent vaccine covers the two most common cancer-causing HPV strains as well as two others that commonly cause warts.
As for whether a test like this would be useful in clinical practice, it would definitely depend on the situation. HPV is extremely prevalent ... by the time a person has been sexually active for a few years, it is almost guaranteed that they carry at least one strain of HPV (there are about 40-50 strains last I checked). However, most people never have any problems related to HPV, either because their immune system effectively suppresses the virus or because they have a strain that does not cause symptoms.
Is it useful for one to know that they carry a non-malignancy forming, non-lesion causing strain of HPV? Is it useful for 50% of the population to believe that they have an STI although it will likely never cause any clinical symptoms in themselves or any sexual partners? I would say probably not. Is it useful to type the HPV strains of all infected patients? Maybe. Currently it would not be useful as we do not have effective antiviral therapies for HPV. However, understanding the epidemiology more clearly could certainly help as we decide which viruses to attempt to target therapeutically in the future.
I will say this: the test described in this article would generally be described as a "fishing expedition" in the lab where I did my graduate studies. These types of studies can be very useful in certain cases but I predict they may also cause a lot of confusion as we begin to find subclinical viral processes occurring in plenty of healthy people. As a society, we will have to change our perception of what it means to be "infected" with a virus and as a clinician, it may become more challenging to reassure patients that they are healthy (gut and skin microbiome data will likely create a similar predicament with regard to bacteria).
In any case, I'm sorry to hear about your difficulties with HPV. I see patients dealing with it on a fairly regular basis and it can be a frustrating situation. I do hope that there are effective therapies on the horizon.
I had the same problems getting testing done (sidenote: I want to explode when a medical institution won't provide a test like this to me, even if I'm paying cash, without a doctor's order).
I skipped the testing and paid the vaccine fee out of pocket (I'm a 32 year old male), and was provided the vaccine at Planned Parenthood.
What's preventing something like this from wide-spread use? I'm always amazed (read: disappointed) humans are still involved in so much of the diagnosis process.
Do you mean: "Why won't this eventually be available on a drugstore counter so I can diagnose myself?"
The FDA's response for decades is this: you don't have a lab to perform a more detailed confirmation (because false positives sometimes do happen), and you have no doctor or counselor to be there with you when you get the results.
I worked for a biotech firm that had an instant HIV test available a long long time ago. It was deemed too irresponsible to let people to check themselves at home because the company (and the FDA, and everyone's lawyers) were afraid of people doing rash things after a positive result. If a false-positive HIV patient killed themselves and the family sues, that would be...bad.
Even today, the home-HIV test that's on the market involves you sending in the sample and then getting a phone call with the results.
This is no longer true. When I went I get tested for HIV in SF at the free clinic, they wouldn't do it because they said I wasn't really at risk(!) despite having multiple female partners since my last test, including a Standford doctor who was in the ER all the time..
Anyway, I went to a pharmacy and paid $50 for an at home test kit that did indeed tell me yes/no in about 15 minutes.
My brother has taken the same kind of test in NYC.
Allow me a flippant response, "nothing." Looking at some of the papers that W. Ian Lipkin has published he's been working on this for a while.
So as a researcher he provides data which the FDA will use to assess accuracy and viability, meanwhile Columbia will probably lease out the patents (https://patentimages.storage.googleapis.com/pdfs/US200600033...) when it issues to a diagnostics company, perhaps to Elizabeth Holmes company (http://www.wired.com/2014/02/elizabeth-holmes-theranos/) who will then create a cost effective way to put this into drug stores everywhere, and when you're feeling bad you go in, prick your thumb, and get a text message of everything you might be sick with.
They needed to do 17 samples at a time to be financially viable. I suspect it's even worse than that and it's just cheaper if you already know what you're looking for and do it the normal way.
The DNA Sequencing related techs seem to advancing even faster than Semiconductor techs.
I used to work for Applied-biosystem to work on their 2nd gen DNA sequencer ~1996. At that time, sequence the human genome cost ~$1 billion. Today it is < $1000.
At that speed, in 10-20 years. They might be able to sequence all the virus in your blood and provide real time info about them with the latest Apple Watch. :-)
Still have doubt? Take a look at what high school kid (lady) did to detect ebola....
Underestimate - from the article, "The team can also analyze many patients at once. To do that, they fuse a unique barcode sequence to the viral DNA from each individual sample, before mixing them together and running them through VirCapSeq-VERT. After the system does its thing, the team can check the barcodes to work out which sample each virus came from. “We can do up to 21 at a time, which makes it financially viable,” says Lipkin."
So, this is the sort of thing that you would do in bulk with a bunch of samples, not on a retail one-at-a-time basis.
2. No software company wants to deal with the liability issues
An example of a place where technology takes over a large part of the diagnostic process is prescription glasses. Even then, after measuring your absolute dioptres, a human asks you to try a few combinations to find the most comfortable variant.
People have plenty of trust for machines, it's all around us. Unless you refuse to use an ATM, for example, the most wide-spread robot in the world, you probably trust machines too. Or automatic transmissions or anti-lock brakes. Nearly all of us trust the emergency telephone line when we need it.
Well actually for 2015 FDA has approved 96% of the new drugs [1] so it's not the same old tough regulator it's been before. Or maybe it's just tough for things that work and allows things that shouldn't be allowed [2].
For comparison, Illumina sequencing with normal viral enrichment might use software like Kraken to perform taxonomic identification of resulting reads. Physical isolation as is described in the article[2] can be a decent way to improve SNR.
This also might be a problem--we may begin finding out that more people carry benign viral infections than we previously thought (ie, subclinical carriers). The more fishing expeditions that we conduct, as opposed to specific viral tests, the more questions we may have about the definition of "clean" blood.
How is that a problem? Questions are good. Defining "clean" blood better is a good thing, preferred to plain ignorance about certain things because they look scary. I am all for more information and questions.
I'm definitely not recommending ignorance, generally speaking. Just pointing out that if you go looking for viral DNA in blood, you'll likely find it in a lot of samples that would otherwise be considered acceptable for transfusions. The latest techniques are finding trace viral DNA in plenty of human samples previously deemed "negative." (1) Now what do you do? Technically, you've found contamination that might or might not lead to disease. Is the blood usable or not?
The point is that we know which pathogens that we need to look out for in transfused blood. Better to continue with targeted tests for the pathogens that actually cause important human disease rather than just fish for everything you can find. And don't get me wrong, this technology could be really useful for better understanding epidemiology or understanding the common viral contents of human blood--I'm excited about the possibilities. I just wouldn't use it in the context of blood banking as I don't think it adds anything helpful (unless we are faced with a novel virus in the future that is being transmitted through blood and needs to be identified).
It'd be cool if they could get this cheap enough to tell the difference between a cold and a bacterial sinus infection. I'm plagued by the latter, but feel guilty about taking antibiotics. It really sucks to feel like crap for 2+ weeks only to realize you could have been back on your feet in a few days by popping some pills.
Agreed. Same with cold virus vs. atypical pneumonia. I've actually been trying to figure out how this could be done for quite a while because it could save a TON of healthcare dollars, sick days, etc.
I really like this. It takes the human element of guesswork out of the equation. Need to do bloodwork? Perform this test and if anything comes back positive, do a different and more thorough confirmation test.
It's a research paper at this point. Pricing comes after FDA approval and the ability to scale.
The article says it is financially viable if there are 21 patient scans done per batch. If an additional breakthrough allows more than 21 patients per batch, then end-user pricing can fall.
