Sunday, February 19, 2006

EPOCAL's Medical Lab Diagnostics on an active Microfluidic Smart Card





POSTSCRIPT 8-22-2015 / preamble > This post is attracting some modest revived attention, particularly by one anonymous reader, in part since I linked this in some few comments I made at Business Insider, about purported technical novelty of Theranos' microfluidic lab tests.

The technology behind both Epocal and Theranos' microfluidic blood tests likely has some generic similarities particularly in function and miniaturization, despite each having gained patents.

Notable if not key, is that in the microfluidics and Micro Total Analysis fields going back to the early 90s, there is a massive hord of patents granted since Dr. Jed Harrison and others in Europe ( Andreas Mainz ) started the field called uTAS micro total analysis. Many of the patents are overlapping in function, albeit different specifics of miniaturization. Meaning many of the patents in this field applicable to miniaturized medical diagnostics are of imperfect intellectual property FTO Freedom To Operate, or do not block others from similar function / miniaturization by different specifics in implementation.

What is clearly unique about Theranos and full credit to the team, is not per se the use of microfluidics in blood medical diagnostics (described in their early patents onwards), but their market go to strategy, to go after conventional blood lab services, via retail outlets, and with microfluidic diagnostics and small blood samples combined, and notably to have developed apparently 400 or more blood tests and counting implemented on their microfluidics platforms.

Again huge credit to Theranos and Elizabeth Holmes, but the core ( microfluidics enabled aspects ) of their technology still is not as unique as some imply ( and do not describe publicly except in Theranos' "public patent documents" )

As to the claimed $8 Billion valuation of Theranos, there are aspects to this that are debateable. Given apparently 400 microfluidic miniaturized clinical grade blood tests have been developed, the "valuation" of the firm is far higher than Epocals when Epocal was sold to Inverness Biomedical ( Boston and San Diego ) just a few years ago, where Epocal apparently had very few tests finished development on its also unique microfluidic blood test platform.

But given that mature incumbents in conventional Blood Lab testing have valuations in the range of Theranos's present value, and serve 1,000 or more ( poss 2,000) types of blood tests albeit with mostly conventional venous blood draws presently, I'd guess Theranos gains some value over conventional incumbents, but not as much as one might hope, just yet ( meaning the $8B valuation claimed due to private equity invenstment valuations might be slightly inflated, not by much ) as the incumbents if getting their act together might not have huge difficulty in mounting competitive microfluidic lower cost blood test offerings at retail pharmacies, to compete against Theranos.

Theranos's patent portfolio functional blocking strength might not be as strong as hoped for due to the plethora of microfluidic uTAS patents, and just for example Epocal's core technology, presently not deployed yet outside of hospital clinical bedside settings, but easily used / modified for pharmacy small blood volume collection for regional Epocal type microfluidc blood testing or actual in Pharmacy tests with similar apparatus.

To be fair, Theranos has a huge jump - early competitive advantage in large scale pharmacy collected microfluidic blood tests. Full credit to the team, market and sales and product strategy can matter more than core technology in company valuations.

But even the earliest dates of patents from Epocal and Theranos are comparable dating to 2005 / 2006 ( of microfluidic topics - hardly comprehensive coverage then )

While the recently recurring anonymous reader might have issues regarding the Canadian aspect to Epocal ( why I do not know ) Epocal was bought out by an American firm in the last 5 yrs, exactly when I do not remember. Inverness Biomedical (now called ALERE) a large firm in Boston and San Diego owns Epocal.

back to the original post dating to 2006 _______________________________________________
Epocal, based in Ottawa Canada, a microfluidics health care diagnostics firm founded by Dr. Imants Lauks, is building a novel compact microfluidics blood diagnostics analyzer on a card, for wide deployment in health care facilities.

Dr. Lauks previously was the founder of i-Stat, later acquired by Abbott, whose biochip based products provide hand held solutions for a number of critical care assays, including: Blood Gases, Electrolytes, Chemistries, Coagulation, Hematology, and Cardiac Markers (cTnI).

Epocal is noteworthy for its vertically integrating microfluidics process / manufacturing capability, with medical chemistry applications expertise.

Where the i-Stat's devices seemed to be mostly passive dedicated substrate sample chips, the Epocal solutions will be lab on a card ( smart card format with integrated active microfluidics, sensors and reagents ) deployed to be measured and logged on small Epocal card readers in the hospital floor setting.

No muss nor fuss - all the wetted parts - channels and sensors and pumps, are on the disposable cost effective smart cards.

Noteworthy is the development at Epocal of smart microfluidic card manufacturing on flex - ie roll to roll substrates. And leveraging the considerable infrastructure / industrial tooling of smart card manufacturing.

This - use of mostly industry standardized smart card manufacturing tooling - is rare for recent attempts to commercialize biotech microfludics diagnostics, especially noteworthy for being readily available off the shelf from numerous vendors.

Epocals Biosensors-on-Flex™ technology processes kapton flex circuits into biosensor arrays in a single continuous roll to roll manufacturing process.

Epocal uses Roll to Roll processing - from raw material manufacturing start, all the way through to finished diagnostic card ready for shipment and use, with rapid throughput in manufacturing.

Roll to Roll Flex circuits are processed using machinery modifed from standard smart card manufacturing, on standard tape-on-reel tooling

Epocal's smart flex substrate cards integrate all active and passive microfluidics to eliminate the need for external pumps, detectors, reagent cartridges etc.

This is a practical manufacturable commercial implementation of micro TAS - Total Analysis System, with a large targetted focused market - hospital blood chemistry tests - test results faster and cheaper than ever before.

The flex kapton based smart card module, forming microfluidics with through vias and back-side metal, is the platform for a generalized biosensor micro Total Analysis system. Each card film via through hole pocket, when loaded with membrane or chemical reagent, implements a microscale bioreactor with integral electrochemical detector.

Membranes and reagents are loaded by roll to roll process integrated micro-dispensing onto the 35mm tape carrier, resulting in the lowest cost solution of any integrated biosensor technology.

Epocal has developed membranes and reagents for application in blood tests that include electrolytes, dissolved gases, hematocrit, and metabolites. Epocal's initial product will be capable of 8 tests, later expandable to12 tests per card.

My take is this firm will be another blockbuster from Dr. Lauks - comparable but likely better than i-Stat became.
Epocal Inc.
2319 St. Laurent Boulevard, Suite 500
Ottawa Ontario K1G 4J8 Canada
Phone: 613-738-6192 Fax: 613-738-6195

recent news from Epocal
Epocal Inc. Completes $31 Million Series C Financing 4/11/2007
Epocal Inc. Receives FDA Approval To Market The EPOCTM Blood Analysis System 0/12/2006

................................................
MW - postscript Sept 2007 -

Below are some pictures explaining the function of the Epocal microfluidics
smart cards, unique for being early in clinical diagnostics deployment, with the high functional complexity on the plastic card, supported by the readers and data management system. Click on them to see higher resolution images.










Here are the published patent and patent applications at USPTO of Epocal at the moment.

US20070170062 INTEGRATED ELECTROKINETIC DEVICES AND METHODS OF MANUFACTURE
Devices with electrokinetic elements are disclosed as well as their method of microfabrication for use in micro-scale analysis, mixture separation and reaction. The devices consist of solid hydrophilic-matrix films that have been microfa...
7214300 Integrated electrokinetic devices and methods of manufacture
Devices with electrokinetic elements are disclosed as well as their method of microfabrication for use in micro-scale analysis, mixture separation and reaction. The devices consist of solid hydrophilic-matrix films that have been microfa...
7201833 Integrated solid-phase hydrophilic matrix circuits and micro-arrays
The invention is directed to analytical devices and micro-arrays with integral fluidic inputs and outputs. The devices are constructed from planar solid-phase hydrophilic matrix circuits containing dry chemical reagents overlaying integr...
7094330 Heterogeneous membrane electrodes
The present invention relates to planar electrochemical sensors with membrane coatings used to perform chemical analyses. The object of this invention is to provide unit-use disposable sensors of very simple and economical construction, ...
US20050150761 Electrode module
A chip-carrier module known from smart card technology is adapted as an electrode array for use in disposable sensing or separation devices containing electrodes. The electrodes are manufactured directly onto chip-carrier module. The pre...
6896778 Electrode module
Planar devices incorporating electrodes for performing chemical analyses are disclosed. The devices include an electrode module in a fluidic housing. The electrode module includes a carrier module and at least one electrode thereon. More...
6845327 Point-of-care in-vitro blood analysis system
Devices for cost-effectively performing in-vitro diagnostic chemical analyses at multiple distributed locations within a medical institution are disclosed. One object of this invention is to provide a network of distributed sensory devic...

And here are issued patents at the Canadian Patent Office (CIPO)

CIPO - Patent - 2449388 INTEGRATED ELECTROKINETIC DEVICES AND METHODS OF MANUFACTURE



CIPO - Patent - 2547701 INTEGRATED SOLID-PHASE HYDROPHILIC MATRIX CIRCUITS AND MICRO-ARRAYS


CIPO - Patent - 2449511 POINT-OF-CARE IN-VITRO BLOOD ANALYSIS SYSTEM




CIPO - Patent - 2449172 PLANAR ELECTRODE MODULE FOR USE IN A DIAGNOSTIC DEVICE

CIPO - Patent - 2547698 POTENTIOMETRIC REFERENCE ELECTRODE WITH HETEROGENEOUS MEMBRANE



.........................................


Watch for Epocal.....

2 Comments:

Anonymous Anonymous said...

Epocal appears to keep missing its projected launch date. Is it really possible to build microfluidics onto a medium not original design for this application, at the target cost?

3:30 PM  
Anonymous plastic card said...

Tips on using active microfluidic smart card in health care facilities in different hospitals.

1:44 AM  

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