In a Home Near You Soon: DIY Tests for Nearly Everything?

More and more do-it-yourself (DIY) medical tests are coming down the pike.  This week A DIY home HIV test will be reviewed by the FDA’s Blood Products Advisory Committee, they are expected to give guidance on potential OTC status for the OraQuick Advance test on November 3.  The manufacturer, Orasure Technology, currently sells the kits to clinics and doctors for less than $20 each.

This past week, scientists from the Morgagni-Pierantoni Hospital in Forli, Italy published a paper in JAMA demonstrating efficacy of a urine test for bladder cancer.

Maria Aurora Sanchini et al. "Relevance of Urine Telomerase in the Diagnosis of Bladder Cancer" JAMA Vol. 294 No. 16, October 26, 2005.

Bernard M. Branson, MD. "Home Sample Collection Tests for HIV Infection" JAMA. 1998; 280:1699-1701.


Leroy Hood on the Future

Leroy Hood, tireless generator of good quotes (among other things):

My prediction is that within 10 years, we will have a predictive medicine that will have two separate components.

No. 1, it will have the ability to sequence every human’s genome for
less than $1,000. We will be able to make predictive health histories for each individual from the varying genes that come from that

Perhaps a better term than predictive health histories is
health futures.  Is it me, or does having health sandwiched between predictive and history feel claustrophobic?

No. 2, we will have a little hand-held nanotechnology device that
will prick your finger and make a thousand measurements and by
wireless, send that to a server. It will analyze all your past records.

It will say, "Nothing’s changed. You’re fine. Do it again in six
months." Or it will say, "Go see your oncologist or go see your
rheumatologist" or whoever might be appropriate.  Your physician would get an e-mail, too.

There’s more from Leroy:

Take into account that your genome and mine differ by 6 million

We have to treat you differently than we treat me and everybody
else. How we create an era of highly personalized medicine will depend
entirely on new diagnostic, therapeutic and ultimately, these
preventive techniques.

What we’ll do is feed your genome sequence into a grid network of
computers that will do many different kinds of analyses simultaneously.
You’ll get a summary sheet that says here are the things and here are
the probabilities that you’ll likely have to worry about in the future…

Oh yeah, and this is good too..

It takes five years for people to get anything. The first few times
they hear it, they can think of a thousand reasons why it’s wrong.
Then, after they’ve heard it a few more times, it starts to sound more

If you’re a missionary, you’ve got to be patient with your
congregation. We are at the very beginning stages of thinking about

Read the whole piece in the SeattlePI.

Genetic screening for the benefits of exercise

An example of a genetic test intended to help medical consumers make lifestyle choices appears to have emerged.  According to this press release, BodyMedia has negotiated an exclusive license to genetic technologies based on research “investigating what a person’s genes say about how much their health can benefit from a moderate exercise program.”  This research has been led by Dr. James M. Hagberg of University of Maryland (nice biography here, scroll down; publications here).  Dr. Hagberg’s “team has identified genetic markers that predict particularly significant exercise benefits for patients with a variety of conditions, including high cholesterol, hypertension, diabetes, osteoporosis, and obesity.”  According to an article in the Pittsburgh Business Times, BodyMedia “will integrate the university’s genetics-based guidance with its health-monitoring products.”   

Glyn Moody on Googling the Genome

Glyn Moody, author of Digital Code of Life : How Bioinformatics is Revolutionizing Science, Medicine and Business has an article in the Guardian on the possibility of more or less googling your personal genome once the price of sequencing comes within range of the pocketbook.  One could even imagine a service similar to their "news alerts" where individuals are kept abreast of relevant advances in genomic medicine as they occur:

A bioinformatics program running on a PC could easily check our genomes for all genes associated with the autosomal recessive disorders that had been identified so far. Regular software updates downloaded from the internet - like those for anti-virus programs - would keep our search software abreast of the latest medical research.

Genetic testing will morph from a clinical to a computational procedure.  Even though the speed and efficiency of searching through the genome for blemishes might be as painless as running spell checker in a word processor, the disovery of misspellings might not be.  People will be faced with decisions about the types of constraints to place on genome searches.  While some might feel comfortable surfing their genome on their home computer others will undoubtedly want to foreordain, say, that search results include only treatable diseases. 

Moody also points out that privacy will be an issue: Who gets to google my genome besides me?  Employers?  Insurers?  Police?  Family members?      

Glyn Moody, Googling The Genome, The Guardian, April 15 2004.

(Thanks to Kristofer for the pointer)

Continuous Health Monitoring: The Ring Sensor

This month’s MIT Technology Review has a brief mention of a "ring sensor" device being developed by Harry Asada and Phillip Shaltis.  Have a look at the prototype here.  A medical patient wears this ring and it monitors various vital signs such as heart rate, temp, and blood-oxygen concentration.  The device is also wireless enabled, so the data can be sent to another device such as your computer.  Couple this with a toilet that can perform a urinalysis, such as the Glycosuria Checker WELL-U II by Toto, and one can begin to see the front edge of continuous health monitoring.

Personal Digital Doctor

"Ideally, a patient with an incurable, life-threatening disease such as diabetes would take critical medical measurements at home each day, and immediately get advice from his or her doctor. While that remains impractical, new hope is on the horizon for digital monitoring systems that will help to fill this yawning gap—and to provide clues to each patient’s treatment that no doctor could ever gather manually. This summer, Joslin will partner with Boston startup InterMed Advisors on a trial of one such alternative—a soup-to-nuts home monitoring system for diabetes patients. The InterMed project will combine patient education, daily in-home monitoring of blood glucose levels, and advanced analysis of the wealth of resulting data. It will also alert clinical staff as needed, and provide patients with daily, individualized feedback."

Eric Bender, Your Daily Digital Doctor, Technology Review, Feb 20 2004.

Interview: Molly Joel Coye

Mike Dougherty, LEADING QUESTIONS: Looking Down the Road, Health Leaders Magazine, Nov. 2003.

This article is an interview with Molly Joel Coye MD MPH, the founder and CEO of HealthTech.  Her comments contain no surprises and are a welcome reaffirmation of the excitement surrounding the health IT field.  First, her opinion about future trends in health technology:

"…increasing consumer demand will meet a truly exploding pipeline of clinical devices-both implanted and worn-that will be used to replace natural functions to support, function or aid in treatment as chronic disease takes its toll."

On the future of electronic patient record (EPR):

"The electronic patient record is one of the three or four components important in the next three to five years in IT. The first stage is development of regional platforms for data sharing. Regional platforms often begin with eligibility lookup, claims lookup and eventually claims processing, and progresses to clinical data sharing beginning with laboratory and pharmacy and working out from there. There’s a growing national awareness of the urgency of the need for better information in healthcare. If, in the next two years, most of the necessary clinical data standards are established, we will be entering a new era as vendors sell IT systems that are compatible with the standards. The use of the EMR should grow steadily over the next five to eight years, and ultimately will be the most important piece of the puzzle of advancing quality."

The portable genome

Walter Gilbert, of the Hubbard Center for Genome Studies, carries around a copy of the human genome on his Apple iPod.  See articles here and here.