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Mar 24, 2016 12:04 EST

Resolution Biomedical – Next Generation Liquid-Based Cytology: Our signature FDA-registered test kit yields the most visible, high-quality cells for examination

iCrowdNewswire - Mar 24, 2016

Resolution Biomedical

Next Generation Liquid-Based Cytology

 

Resolution Biomedical is the innovator providing next-generation, liquid-based cytology products for medical laboratories and healthcare professionals that improve testing results for multiple cancers.

Our signature FDA-registered test kit yields the most visible, high-quality cells for examination, improving cancer screening outcomes more effectively and more affordably than anyone else in the market.

Read on to discover how Resolution Biomedical is raising the standard of cancer screening around the globe.

 
 
 
 

A fundamental process in detecting and diagnosing a number of cancers — including cervical, oral, anal, and bladder — is cytology: the study of cells under a microscope.

Cervical cancer is one of the most common cytological tests conducted, with screeners relying on a Pap test to extract cells from the cervix to examine on a slide beneath a microscope. It is absolutely paramount for screeners to be able to see these cells clearly on the slide to properly detect abnormal (cancerous and precancerous) cells and rule normal ones out.

But current machine-based testing methods can result in cells that clump together — meaning screeners can’t see abnormal cells hiding at the bottom of a grouping. What’s more, these automated, market-leading tests are expensive, high-maintenance and lack the crucial ability to adapt to differences between samples.

The reality is, not all patient samples are created equal. Cytotechs and pathologists need a testing system that takes difficult patient samples into consideration and allows for adjustments to be made accordingly — resulting in slides that are uncompromised and as consistently accurate as possible.

Resolution Biomedical is providing that test.

 
 
 
 

ClearPrep uses a chemical-based process that delivers a more consistent, more effective, and more accurate cell-to-slide application than what is possible with machine-based systems. ClearPrep also provides enough leftover samples for molecular testing for HPV, chlamydia, gonorrhea, herpes, among others.

Our proven diagnostic preparation process creates a true mono-layer of cells that are vivid, high-quality, and don’t require complicated and expensive equipment to produce. Added to that, our technology makes it possible for laboratories to make “sample specific” adjustments that eliminate mechanical artifacts and reduced cellularity.

For laboratories, ClearPrep means a more affordable testing solution than alternatives, and a sensible way to upgrade screening technologies without the added need or cost of capital equipment.

For pathologists & technicians, ClearPrep means a simpler and more reliable way to collect, preserve, and place cells, ultimately allowing screeners to do their job better.

 
 
 
 

Here’s how Resolution Biomedical harnesses state-of-the-art testing innovations to deliver the most effective results of any other alternative on the market.  

How Does ClearPrep Work?


Our collection vial features patented ridges on the interior wall to guarantee maximum sample removal and prevent screeners from throwing away the collected cell sample.

A buffered alcohol solution ensures maximum preservation of all cell types present in a patient sample.

At the lab, the sample is centrifuged to compact the cells together. Next, the preservative is discarded, leaving behind a compact pellet of cells. Our proprietary reagent, ClearPrep Cytology Solution, is added to the sample. The reagent causes the cells to slide off of one another when dispensed onto the glass slide, creating a true monolayer of cells that are well-preserved and highly visible. No other product does this like ClearPrep.

 
 
 
 

ClearPrep Saves Patients
Sally, a 64-year old grandmother in otherwise terrific health, was diagnosed with a high-grade cervical lesion and was scheduled for surgery. After hearing about ClearPrep, she cancelled the surgery and had a ClearPrep sample taken. Her original diagnosis turned out to be a false positive — caused by the machine that prepared her initial sample slide.

ClearPrep saved Sally from surgery — and a high-risk designation for the rest of her life.

Additional Paps confirmed this result. Now, instead of dealing with post-surgical follow up, Sally is awaiting the birth of her newest grandchild.

ClearPrep Saves Laboratories Money  
In late 2014, a laboratory in Los Angeles County, California converted to ClearPrep. They saved a total of $80K in 2015, improved their screening accuracy, and reduced the incidence of rejected, or so-called UNSAT samples.

ClearPrep Surpasses the Competition
Clinical trials comparing ClearPrep to conventional preparations and to the two leading machine-based technologies showed that the ClearPrep slides are superior to the conventional preps, and at least as good as the more automated systems.

 
 
 
 

Resolution Biomedical is already off to a great start, and we’re in the process of building on our momentum to make way for even more exciting developments aimed at raising the standard of cancer screening around the world. Here’s a rundown of our achievements so far:

Validated Demand
Even though RBI has been in a pre-marketing stage, the company has generated nearly $500k in revenue in the past three years, increasing steadily each year, with paying customers in 13 countries and active prospects in 35 more.  

Certified
ClearPrep products are registered as FDA Class I devices, so they can be purchased, validated, and implemented for any type of cytology in the US. However, in order for the company to make claims for cervical screening,
ClearPrep needs to obtain a Class III approval. This will allow the company to advertise the product and compete head-to-head against the market leaders. ClearPrep has been approved for CE Mark for distribution in Europe. In addition, ClearPrep has been approved in Brazil, Australia, Paraguay, Chile, Hong Kong, New Zealand, among others, and is in registration in China, Russia, Mexico to name a few.

Patents
Two patents issued, one patent pending, and three trade secret reagents in our toolbox.

Published Studies
UCLA and USC have both published studies and UCLA will participate in the FDA Class III clinical trial.

Partnerships & Distribution
RBI sells ClearPrep direct to laboratories in the US, and through distributors internationally. At current, RBI has distributors in place in various countries around the world:

Capacity  
Our facility’s current vial-filling capacity is 6 million vials per year, and all components are very scalable.  

What’s Next for Resolution Biomedical?
The medical testing is complete and ClearPrep is already on the market and approved for use for any type of cytology.

Upon receipt of Class III approval in the US, we plan to leverage PR and start marketing to gynecologists and adding a salesforce and customer service members. Class III approval in the US will also validate and bolster our efforts in every other country.

Find out more about how you can help Resolution Biomedical reach these goals by requesting access to the business plan page of our profile.

 
 
 
 


Michael has over 30 years of financial and operations experience with public and private companies. He previously served as a managing director for the Crestwood Pacific Group, a private equity firm with portfolio companies in the US, Germany and China, and as CFO for MindArrow Systems, a publicly-traded digital marketing company now part of IBM. His senior executive experience includes roles with emerging technology companies in the US, Europe, and Asia. He is an inventor (two US patents) and author (articles published in the Journal of Accountancy and CMA Management). Michael has a Bachelor’s Degree in business from Kent State University, and began his career as a certified public accountant. 


Dr. Williams brings decades of experience in cytology and women’s health care to RBI. He is a co-founder of RBI and is the principal inventor of our ClearPrep Cytology Solution, Collection Vial, Microscope Slide and GyneMed Brush. Before RBI, Dr. Williams served as the Director of Cytology for the Central Medical Laboratory in California, and laboratory director for Newport Pathology and Empire Pathology. Dr. Williams has served on the National Best Practices Team for Cytology for Smith Kline/Quest Labs; as Principal Cytology Advisor to the World Health Organization, Caribbean Division; and as founder and medical director of Caribbean Cytopathology in the French West Indies. He earned his M.D. at Nacional Univ. de Mexico, and did fellowships in cytology at Charing Cross Hospital in London, at Swiss University Hospital in Bern and at UCLA in Los Angeles. 


After earning a J.D. from Columbia Law School and an M.B.A. from Harvard Business School, Robert served as an engagement manager for McKinsey & Company. He currently serves as Chief Commercial Officer for Solazyme, Inc., a publicly-traded biochemical company. Prior to joining Solazyme in January 2014, Mr. Webber held several C-level positions with both publicly traded and privately held companies in industries ranging from agriculture to technology to resort operations. Robert is the go-to advisor and strategist for Resolution Biomedical.

Before RBI, Terry served as VP of Marketing & General Sales Manager for International Paging & Cellular Corporation, where he expanded the client base from 18,300 to over 135,000 in five years. He was also Director of New Business Development for World Marketing, Inc., and served as marketing director for medical device firms Noble Biomedical Sales and eLab Supply. He is a graduate of Chichester College in England.

Dr. Smith has over 15-years of experience in regulatory affairs and the development of novel technologies from concept through commercialization. He is also experienced in quality and data management systems, supervision of R&D, development of new product specifications, and evaluating and registering medical drug and device product lines. Dr. Smith obtained his Ph.D. in Pharmacology and Toxicology from the University of California, Irvine

 
 
Contact Information:

Michael
Dr. Williams

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