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Hickory Clinical
A new approach to clinical diagnostics
Hickory Clinical is developing portable personal laboratory systems for blood testing.  A clinician using a personal laboratory can assay a patient's blood in minutes with significant cost savings.

This accelerates patient treatment, reduces transactions, and cuts the cost of effective healthcare delivery. 

A personal lab is not a Tricorder (though it could play one on TV). The product does not use magical or bleeding edge technology. Personal lab systems use the same well-developed wet chemistry techniques as centralized laboratories. Blood samples come from finger sticks--one or two drops per patient.

The test menu includes upwards of 30 resident tests per device including metabolites, such as glucose and cholesterol, enzymes, electrolytes, immunoassays, and differential CBCs.

The system splits analyzer functionality between an analyzer about the size of a phone and a tabletop base station that preps the analyzer once per day. The analyzer handles only one sample at a time, eliminating the complexity of central lab systems that stockpile hundreds of samples. The base station removes wastes, cleans the system, preloads reagents, and runs calibration and controls without user intervention.

An app on a phone or tablet controls data entry and sends results to patient electronic records. Test results are available in less than five minutes for most analytes.

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Hickory Clinical--Answers at hand.
Technology
Established methods @ uL scale
Established methods @ uL scale
Hickory Clinical products use established chemical analytical methods, in many cases incorporating reagents already approved by FDA. The system handles fluids using miniature pumps and plumbed reagent reservoirs together with optical, potentiometric, and impedance measurement devices.

The fluid scale is on the order of microliters.

The company's products are designed for CLIA waiver in US with results quality comparable to central laboratory analysis. CLIA-waived devices must operate without significant user training, upkeep, or maintenance. Unlike other CLIA-waived devices, the Company's products support a full day's testing with nightly automated setup. Full calibration and quality control processes are similar to a central laboratory but require no user intervention.  

The base station stores bottles of test reagents to support about a month's worth of testing. A user reloads these bottles as they run out. The base station sends records of test usage (without any patient identifying information) to the Company for billing and resupply.

The personal lab concept differs from competing analyzers in two important aspects. First, the system uses long-established liquid test methods without costly single-use disposables. This is possible in a handheld device because the base station supports many of the analyzer functions, keeping size and cost down. The second difference is the use of multiple analysis methods in the handheld analyzer. Normally, such diverse methods require multiple analyzers. These can be combined in a single device because, as a point of care device, the analyzer has a low duty cycle--it is unused much of the time.The analyzer takes advantage of these unused periods to set up assays of different sorts for when they are needed. 

Simple operation
Low duty cycle advantage
  1. Challenge
    The implementation of the Affordable Care Act in the US highlighted that cost reductions in medical care do not flow readily from administrative or legal actions. Cost savings absent compensating trade-offs in quality or access arise only from increases in productivity, and productivity increases require process changes. Past medical improvements, primarily directed to better treat or diagnose diseases, aim to decrease costs incidentally by earlier diagnosis or treatment. Most such improvements have actually increased the cost of care. Most in vitro testing is performed in hospital or free-standing clinical labs. These labs resemble large automated factories with multiple high throughput systems, each dedicated to a single family of tests. This specialization is needed to cope with the enormous volume of testing but paradoxically adds to costs because centralization of tests necessitates extensive sample handling and high end automation.
  2. Market
    The global market for in vitro diagnostic testing exceeded $60B in 2016 and is expected to reach $85B by 2024. Most of this testing is ordered by physicians but performed and billed by others. The charges for testing usually exceeds the charges for physician services. Past centralization of testing in pursuit of economies of scale has sub-optimized both delivery of care (results typically take hours to days) and overall costs (transactions needed to centralize add costs). Localized testing overburdens physician practices because it has required time and expertise not readily available. Hickory Clinical's products will reduce or remove the time and expertise requirements making point of use testing a practical alternative.
  3. Opportunity
    The Company's personal lab products reduce costs by eliminating delays for most lab tests. Results are available within one to ten minutes, so that the provider may perform the next step, whether diagnostic or therapeutic, while the patient is still present and while the case is still fresh in the physician's mind. Hickory Clinical's personal lab system retains income at the point of care, aligning incentives for health practitioners with those of patients. The reduced total costs can maintain or increase provider reimbursement while reducing charges to patients and third party payers.
Patents & Applications
Hickory Clinical has an active intellectual property program with patents and applications in major market jurisdictions.

Issued patents:
     US 7431883
     CN ZL 2014800095423

Applications with allowed claims: 
     EP 14770330
     US 14/773373

Other applications pending.
About Us
Hickory Clinical is a development stage company. It's staff works together with commercial suppliers of reagents, and vendors of mechanical, electronic, optical  and software services. 
Contact
Michael Bell
  
Founder and principal of Hickory Clinical.
His expertise includes clinical system design, systems, mechanical, electronic, and optical engineering, programming, assay design, patent prosecution, and intellectual property analysis. Michael Bell has 38 years’ experience in clinical system design and development, including 29 years at Beckman Coulter, Inc., a leading manufacturer of hematology and chemistry systems. He is an inventor on at least 28 U.S. patents in diagnostics and biomedical research products. He has led projects in clinical chemistry, immunochemistry, and flow cytometry that have resulted in hundreds of millions of dollars in commercial sales. He has been a principal in two earlier startups and one funded initial public offering. He is also an attorney specializing in intellectual property. 
  

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