Friday, March 9, 2012

Major Companies Move Into PMx

A mention of Kalorama's personalized medicine market forecast in this Healthcare IT News article.   The magazine is published by HIMSS, the top trade association for tech companies involved in the healthcare space.   

Thus its not surprising that they make note of the digital connection to personalized medicine(PMx); the tech that will be needed to analyze data gathered to make the concept more of a reality.   And they note GE's recent acquisition of NanoString, whose nCounter Analysis System, is a fully automated platform for digital gene expression and other applications requiring the detection and counting of single molecules.

 They also note Dell's recent launching of a cloud computing technology to support pediatric cancer research programs, including what's billed as the world's first personalized medicine trial for pediatric cancer, conducted by the Neuroblastoma and Medulloblastoma Translational Research Consortium (NMTRC) and supported by the Translational Genomics Research Institute.

Thursday, March 8, 2012

How New is "Personalized Medicine?"

Not as new as you think.  If we define personalized medicine as 'using testing to develop and individual therapy for a patient,' then there are all sorts of diagnostic products that fit the category of 'personalized.' or as we say PMx testing.   This broad scope is used by our analyst Shara Rosen in her latest report, Personalized Medicine Diagnostics.   

Glucose testing, antimicrobial susceptibility testing (AST), blood typing, transplant typing,
HbA1c testing, coagulation testing.  These are among the tests already on the market and in routine clinical practice that can be said to do the same thing that any novel companion diagnostic test does: align a treatment strategy to the individual characteristics of the patient.   Another way of stating this broad scope in lay language perhaps is: tests to decide if a patient gets Treatment X, Treatment Y, both Treatment X and Y, or no treatment at all.  It's almost always applying to drugs but could in future applications apply to radiology or surgery. 

With all of these testing methods considered, and the new tissue diagnostics and tumor marker studies considered, Kalorama estimates a 28 billion-dollar market for tests that are personalized to a patient.  The primary growth drivers in the market for PMx tests, are the continued discovery of protein and genetic markers with proven clinical utility, the increasing adoption of these diagnostic tests as markers for personalized medicine, and the expansion of reimbursement programs to include a greater number of companion diagnostic tests. 

 Our recent report states in it's methodology section that "In accordance with a broad application of PMx, the market estimate in this report covers tests that can also provide therapy decision-making information that is tailored to the individual in the following ways:

  • Tests that identify a population in which the therapeutic product will achieve greater (or little) effectiveness.
  •  Tests that identify a patient population that should not receive a particular therapeutic product due to the possibility for therapy-related serious adverse events.
  •  Tests that identify the characteristics of a disease, condition, or disorder to specifically determine what type of treatment is appropriate.  This area of disease stratification is one of the fastest growing areas of personalized medicine.  It includes tests for: tumor aggressiveness, risk of tumor reoccurrence, aggressive rheumatoid arthritis, pathways for severe cardiac disease and many others. 
  •  Tests that are the basis for selecting a safe and efficacious therapeutic dose.  This is probably the oldest application of PMx that has been in use in clinical laboratories for at least 50 years. "
Our report details specific market estimates but overall it makes it clear that PMx testing is on an upswing; the number of assays introduced has been growing at a remarkable clip.  The expanding menu of PMx tests can be attributed in part to the publication of the human genome project and advances in functional proteomics, bioinformatics, miniaturization and microelectronics. 


Sunday, March 4, 2012

Portable Units Could Ease the Sequencer's Move to Clinical Labs

 A sequencing device that is the size of a USB memory stick and that costs under $1,000.  Right now, it sounds like science fiction.  According to a recent New York Times article, this development is possible if a company named Oxford Nanopore is able to produce a very different kind of DNA sequencer as promised by the end of the year.  
Sequencing currently requires samples to be sent to one of a few central labs with a sequencing device.  The instruments are large and costly.  Price varies, but top models can cost more than half a million dollars.  A few companies, among them Roche, Illumina and Applied Biosystems compete in this market.  Price is not the only competitive factor - as cheaper models such as Polanator that use open-source technology and bring the price down to 170K have not made a dent in the market for the higher end systems; Kalorama's surveys of this market show  throughput and accuracy win out here.  Though the proposed price is much lower for the portable sequencer, its unclear that a nanopore or 'strand sequencing,' which Oxford relies on, has the accuracy/resolution of the next-generation sequencers.  
If it does it is not only the price but the portability that could disrupt the market.  Such a device might bring dna sequencing into the point of care (POC) diagnostics market, and as the article details, may help doctors to sequence genes at a patient’s bedside, wildlife biologists to study genes in the field, or food inspectors to identify pathogens.
Kalorama Information's latest report on personalized medicine diagnostics details the increasing role and potential of sequencing in clinical use.  The introduction of a portable unit with the capability to present results on a standard laptop could increase the penetration of sequencing.

A hurdle remains even if a portable unit is developed -- data analysis.  It's one thing to sequence a tumor or a pathogens in food, its another to inspect the office physician or hospital lab tech to be able to crunch very large data sets analyze the meaning of dna sequences to a preciseness that makes it relevant to treatment decisions.  Well-designed  computer software will be needed to get from the taking of a sample to a diagnosis that can impact treatment.