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Fluimetrics, Inc.

A diagnostic application development company

Presenter: Lawrence A. Sasso PhD, President of Fluimetrics


Monday, October 14, 2013

Embassy Suites, Chesterbrook, Pennsylvania (directions)




Fluimetrics is working to fulfill the demand for next generation automated diagnostics in emergency and personalized medicine applications, using a unique patent-pending technology. Fluimetrics’ product will be a small laboratory instrument enabling rapid, sample-to-answer automation of immunoassays within an inexpensive, disposable lab-on-chip device. Due to the technical limitations of current first-generation automated diagnostics platforms, there is a demand for new platforms with larger test menus and a lower cost per test. Fluimetrics intends to market the product for emergency medical tests including cardiac and sepsis biomarkers, and companion diagnostics.


Hospitals are continuing to integrate on-site testing products to their workflow, both because of the need for rapid results in emergency applications, and due to the profitability of automated diagnostics. The $2.4B market for rapid cardiac biomarker tests represents 15% of all hospital-based testing, and has been growing at 12% per year. Biomarkers for other emergency situations, such as sepsis and stroke, are being developed and undergoing regulatory trials. Hospital laboratories want to perform all of these tests on a single platform, and are also interested in providing personalized medicine diagnostics, such as oncology biomarkers, on the same platform. Fluimetrics is developing a new technology that allows any microbead-based immunoassay to be completely automated in a simple-to-use instrument, without the need for a skilled operator. The technology allows the unique ability to integrate standard laboratory reagents into a rapid lab-on-chip test format. The company has shown proof of concept for the technology and has developed a scalable production process for the disposables to demonstrate cost targets.



3 Major Issues


  1. While there are many application areas for immunoassay diagnostics, we believe that there are three major market categories where our technology could be competitive: 1) a mass-use medical product for cardiac and other blood markers in emergency and personalized medicine applications, which would require 510(k) clearance; 2) a niche point-of-care application with minimal competition but an untested market (e.g. sepsis), which would likely require a PMA; 3) a biodefense application (e.g. botulinum and other toxins or agents). Considering that our short-term goal is to attract financing for product development, should we continue to focus on the emergency medical space, or shift our focus to another application area?
  2. What is a realistic estimate of the cost to bring the full system through the 510(k) process for the first application, assuming the diagnostic target has a predicate (e.g. cardiac troponin), and what would it cost for additional 510(k) clearances for other targets with predicates?
  3. We believe that it may be possible to attract an early acquisition by a large diagnostics company after demonstrating a working prototype. If we are not able to attract an early acquisition what is the best partnership model to pursue for marketing and distribution, and could it be feasible to market the product on our own as was initially done by Biosite (now Alere Triage)?





6:30 - Cocktails & Dinner (Cash bar and special 2-entree buffet menu)

8:00 - Lawrence A. Sasso PhD, President of Fluimetrics, will deliver the Company's "Elevator"
Pitch to the Group

8:20 - A Panel will address 3 Major Issues for the Company

9:00 - Open discussion: members and guests



Available Media

Please note: All information obtained here is the property of those presenting and should not be copied or duplicated without written consent.



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Fluimetrics Webcast - 10/14/13

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Contact: Peter van der Kam, | (610) 296-8086




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