Success Stories in Clinical Research and Testing


Improving ELISA Sensitivity and Linear Range for IVD Testing and Research

Utilizing Human Genome Information

Optimizing Microarray Platforms and Chips to improve accuracy and lower cost

Patent Portfolio Creation: Personalized Disease Management

Patent Portfolio Enhancement: A New Diagnostic Platform – miRNA Reagent Kits


  1. Improving ELISA Sensitivity and Linear Range for IVD Testing and Research


Problem Poor sensitivity and dynamic range for critical IVD testing and other important research analytes.
Solution Coalesce worked with a start up, IGEN, with IP around a new technology, Electrochemiluminescence, that promised higher sensitivities, no need for radioisotopes ; extremely low detection limits (100 fmol/L); dynamic ranges over six orders of magnitude, and stable labels that can be used to label larger molecules. Coalesce discussed these advantages with pharmaceutical and diagnostic companies, arranging meetings with them so they could further evaluate and validate it, and facilitating setting up FTE based laboratories inside pharmaceutical organizations to further test and develop the technology.
Result Electrochemiluminescence (ECL) is now a highly sensitive IVD method which constitutes a large part of the $45+ billion dollar global market for IVD measurement. Roche Diagnostics Division ultimately acquired the clinical rights to the technology. The method is highly sensitive and works extremely well with complex clinical samples. It is also heavily in research. Measurements are simple and rapid, and require only seconds.


  1. Utilizing Human Genome Information


Problem Newly developed human genome information sometimes contained the Pharma organization’s genes of interest and sometime it did not. Also there were issues of security, the optimum ways to query such information and other critical questions. New and better ways of taking advantage of the wealth of information were desired.
Solution Coalesce worked with both Pharma organizations and genomic data providers to communicate and resolve issues and questions regarding the optimum ways they could work together. Also, Coalesce worked with Pharma organizations and genomic data providers to develop gateways and program definitions and to create powerful interfaces that Pharma organizations could use to better query their data, examine alternatives and choose the best solutions.
Result Successful interface protocols were facilitated between Pharma organizations and genomic data providers. Many new electronic portal gateways were developed and implemented to support rapid and successful querying of the human genomic data for discovery of new therapeutics.


  1. Optimizing Microarray Platforms and Chips to improve accuracy and lower cost.


Problem New Microarray Platforms were developed and offered amazing capabilities, but there were issues regarding the best platforms to use and the design of the chips themselves, especially regarding acceptable false negatives and false positives, footprint, number of features, security and other issues.
Solution Coalesce gathered the input of multiple premier life science groups to develop the specifications of the optimum microarray platforms and the optimum chips they needed to do their work. Coalesce then worked with Microarray platform and chip providers to develop and provide the most useful platforms and chips to the research organizations and for Pharma discovery.
Result Microarray platforms proliferated and were widely adopted. Initial costs were high, but gradually decreased to more acceptable levels. Far better chips were made with better accuracy and specificity and at lower costs. Chips were eventually designed with millions of features, ensuring greater coverage and better security and these custom designed chips could be made delivered in a matter of weeks and at low cost.


  1. Patent Portfolio Creation: Personalized Disease Management


Problems In early 2000 a start-up company, Celera, faced the following threats to its longer-term survival:

– Mission was initially to only sequence the human genome
– No scientific applications to help researchers
– Poor software interface designed by IT gurus without input from User Scientists

Solutions Coalesce Research conducted in 3 Phases over the course of about 1 year:
1) Mid-2000: Initial Genomics Market Research:

– Designed to determine Initial Market Requirements in Industry & Academia
– Revealed the Necessity for Additional Market Research to Find Specific Applications

2) Late-2000: mRNA Expression Products and Services Market Research: Determined Specific Applications Required in Industry & Academia

3) Early 2001: SNP Market Research Report: Uncovered and Prioritized Additional Specific Applications to help Researchers in Industry & Academia

Results 1) Client Built an Entirely New Patent Portfolio (27 Patents) for Market Needs Identified by Coalesce:

– Specific Applications: Cancer, Cardiovascular, Alzheimer’s, Neurodegenerative, Inflammation, and others

– Improved Software Interface Based on User Feedback from Scientific Communities in Industry & Academia

– Developed Additional Tools including to Improve Gene Expression Determinations, Annotation, Detection of Low Abundance Expressed Sequence Tags (ESTs), and High Throughput Proteomics

2) Company was eventually sold in May ’11 to Quest Diagnostics for around $671 million



  1. Patent Portfolio Enhancement: A New Diagnostic Platform – miRNA Reagent Kits


Problems Coalesce worked with a start-up company, Febit, which had limited IP and was struggling with the following problems with their new diagnostic platform – miRNA reagent kits:

1) Too expensive (approx. $21K)

2) Initial Patent was collecting dust

3) Internal company debate: Out-license or develop more IP?

Solution Coalesce Research – Validated market requirements

– More kits including several versions demanded by market to cover more miRNAs

– Lower prices

Results Client Actions:

– Kept the IP in-house (not out-licensed)

– Patent family expanded to 4 more patents covering market demand

– Successful market penetration of new kits