Rapid Non-Invasive (Saliva-based) Diagnostic Platform
Diagnostic company located in the West coast is looking for a strategic partner to move the company forward. The company is pioneering the development of tools for both laboratory diagnostics and point-of-care testing based upon saliva samples. The Company's Oral Fluid Collection Device is used to collect saliva for multiple purposes in the laboratory including HIV, drugs, DNA, RNA, steroid hormones, etc. The Company’s Rapid Diagnostic Testing Platform Technology is an enabling technology for a multitude of non invasive (saliva based) applications in the near-patient or point-of-care diagnostic testing segments.
Award-Winning Technologies
Recently, the company received an investment award from a noted organization devoted to helping visionary entrepreneurs in the Pacific Northwest. This company was selected by the Awards Committee from among 12 finalists whose commitment to new technology stands out in the crowd. As part of the award, this company received $50,000, important connections to accredited investors and support in the form of educational tools and resources that will support its growth.
Three Product Lines To Address Multiple Markets
The company has three product lines planned - one of which is already commercially available today, while the second device is in validation and planned to be released later in 2009.
These devices are as follows:
Versatile Saliva Collection Device
This is designed to collect saliva for any application where saliva is required. The device has a unique sample sufficiency indicator, which is triggered once sufficient saliva is collected for analysis. The device provides about 0.5 mL of pure saliva into a standard Eppendorf tube that is then sent to the laboratory for testing.
In order to expand the applications for this device, it can come with a range of immunoassay test kits, including kits for drugs of abuse, for steroid hormone testing, and for HIV. The company is working with other partners with suitable assays to expand the menu. The company will then have the ability to offer the collection device with a broad menu of tests to provide a one-stop shop for customers. The applications for this are as varied as the number of diseases to test for in blood.
This device is commercially available today.
Saliva Collection Device for DNA / RNA
The sole purpose for this device is for extraction of DNA or RNA. The device scrubs cells from the mouth in less than 30 seconds and the collected cells are immersed in a buffer in a separate chamber which causes lysis and preservation of the DNA. The complete device is then sent to a laboratory where the DNA extraction takes place or alternatively DNA can be extracted on the spot. In either case, a high quality DNA yield is obtained which is then immediately ready for downstream analysis such as PCR, genotyping, personal genomics, etc.
This device will be commercialized in late 2009.
Platform for Rapid Disease Diagnosis from Saliva
The third device is a enabling test platform for rapid disease diagnosis from saliva. The company has partnered with several companies and is now developing tests for several diseases and biomarkers including those for diabetes, breast cancer, tuberculosis, anthrax immunity, and drugs of abuse. The breath of these technologies indicate how the company's technology is applicable to three major segments of the in vitro diagnostics market - laboratory based testing, point of care, and molecular diagnostics.
These devices will be released in a staggered manner based on different partnerships with partner companies. The company has existing licensee partners but is looking for additional licensees and development partners to expand its reach in salivary diagnostics.
Growth Based on Collaborative Partnerships
The company is currently collaborating with approximately 50 companies on either validation of traditional blood tests optimized to work with saliva specimens, or development of new test menus.
The company has already distributed its entire first production lot of 5,000 units of the saliva collection units. These are being evaluated by partner companies and prospective partners in their evaluation work and could result in much larger production volumes in the near future.
Executing Strategy - Going After Low Hanging Fruits
The company's initial strategy is to go after markets where the regulatory obstacles are low or non-existent, what one would call “low hanging fruit”. A number of such opportunities do exist. Another focus for the company is to go into areas where there is currently no competition. The company is currently focused on entirely different markets where they believe they have currently no competition. One example is the diabetes project with DiabetOmics.
Saliva Diagnostics - A Growth Market
Historically, growth in saliva diagnostics has been quite rapid. OraSure Technologies, a leader in this space, for example had revenues in 2008 of $85 million on three oral fluid products- a saliva collection device, a rapid oral HIV test, and oral drug tests.
However, saliva diagnostics can be applied to many, many different areas - virtually most any place blood diagnostics is being used. The convenience and non-invasive nature of this technology means that there is a wide open market out there.
Next Steps
Our client’s company is looking for strategic partners to broaden its test menu, expand its market reach and develop new partnerships. Ultimately it hopes to have strategic alliances with larger companies that will market its products.
Contact Us
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