The History of Scantibodies Clinical Laboratory
In 1975, a young man with a degree in Biochemistry began to work on 1st generation competitive (RIA) PTH assays at the California Veteran’s Administration Hospital in San Diego, CA. A year later, that young man, Tom Cantor, started Scantibodies Laboratory with the goal of providing improved assay components and diagnostic test kits. Shortly thereafter, he continued his work on PTH assays, developing the 2nd generation sandwich assay which was then called the “intact” PTH assay, with various antibody pairs, some of which were used in the Nichols Allegro™ PTH IRMA assay.
In 1998, Scantibodies developed the first 3rd generation PTH sandwich assay that, unlike the non-specific “intact” PTH assays, measured only the 1-84 molecule and not the 7-84 fragment of PTH. 7-84 PTH was thought to be only a non-biologically active PTH fragment which accumulated in renal failure conditions. But, in 1999, while studying Scantibodies' employees for PTH, it was discovered that 7-84 PTH was not an accumulation product. Scantibodies took the position that 7-84 PTH was a potent hormone, in and of itself, with inverse biological actions to 1-84 PTH, and that a ratio of 1-84 PTH/7-84 PTH would be able to discriminate high bone turnover disease from adynamic bone disease (low bone turnover). With the collaboration of Dr. Eduardo Slatopolsky (Kidney Int 2000; 58:753-761) and Dr. Hartmut Malluche (Kidney Int 2001; 60:1460-1468), new clinical studies were performed and research coordinated with several of the world’s leading authorities, which led to the further demonstration of the biological and clinical importance of the 7-84 PTH hormone. 7-84 PTH was demonstrated to be the “2nd PTH hormone” which, when used in the 1-84 PTH/7-84 PTH ratio, was proven to diagnose adynamic bone disease with 94% accuracy. Other investigators have proceeded to further demonstrate the potent actions of 7-84 PTH which are now being published in renal journals throughout the medical community. In response to this exciting breakthrough, Scantibodies Laboratory opened its subsidiary, Scantibodies Clinical Laboratory, in the year 2000, as a PTH reference laboratory, based upon the clinical benefits of the Scantibodies “PTH Accuratio™ - 1-84 PTH/7-84 PTH ratio” to the clinical community.
Scantibodies and its collaborative partners continue research and clinical studies to progress in the search for yet untapped applications of the 7-84 PTH hormone for kidney disease and other pathologies. SCL has positioned itself through antibody and test development, clinical validation, and regulatory compliance, to efficiently translate future scientific discoveries into patient benefits. The 400 employess of Scantibodies Laboratory, with their production of 1500 products (including First Response and Answer pregnancy test and ovulation predictor kits), support and integrate with the efforts of SCL. Scantibodies is one of the largest and rated among the top privately-held Biotech companies in San Diego. As Scantibodies is 100% family-held, the company has been able to maintain its core patient goals without financial pressure for outside investors. Our mission statmement for SCL says it well...
"Our mission at Scantibodies Clinical Laboratory is to help patients by preventing the debilitating course of disease through accurate and sensitive laboratory testing. "
Our services are dedicated to patients and the physicians responsible for their clinical management. As a result, we are dedicated to improving the quality of services provided to our customers. It is our goal to report prompt and confidential results while protecting the rights of every patient
We know that you have many options for choosing a Clinical Laboratory, but a working relationship with SCL means responsive customer service, third generation PTH testing and accurate and timely reporting. Each and every employee in the SCL family is dedicated to our quality program and providing you with superior service.
Health and Safety compliance
Scantibodies Clinical Laboratory has established a compliance program designed to ensure that regulatory and safety policies are established and enforced throughout the laboratory.
Specimens are handled using Universal Precautions to ensure that our workers are protected from any infectious diseases. SCL complies with the Occupational Safety and Health Administration's (OSHA) Standard on Bloodborne Pathogens (29 CFR 1910.1030). This means SCL has established an "exposure control plan" and all specimens are handled with the utmost caution and care.
In addition, SCL complies with all applicable Laboratory and Healthcare requirements, such as:
- Medicare, Medicaid and Clinical Laboratory Improvement Amendment (CLIA) Programs (42 CFR Part 493)
- Program Integrity - Medicare and State Health Care Programs (42 CFR Part 1001).
- HIPAA (Healthcare Information Portability and Accountability Act) standards for Privacy of Individually Identifiable Health Information (45 CFR Parts 160 and 164)
- International Air Transport Association (IATA) guidelines for Packaging Diagnostic Specimens (UN 3373)
- Publication of OIG Compliance Program Guidance for Clinical Laboratories.
Our Quality Assurance program monitors and evaluates the ongoing and overall quality of the total testing process. This includes all of the activities involved in pre-analytical, analytical and post-analytical processing of patient samples which are undertaken to assure accurate, reliable patient test results. This program includes such practices as:
- Use of controls: The testing of all specimens is done in parallel with a set of controls. These controls are used to continuously monitor the performance of the test and ensure that only accurate results are reported.
- Testing in duplicate: All specimen testing is done in duplicate. This means that each test is performed twice to ensure that the results reported are consistent and accurate.
- Proficiency Testing: SCL works twice a year with an outside testing agency to ensure that our testing meets the gold standard for accuracy and national standards.
At SCL, we're dedicated to ensure that each of our customers receives the personal attention that they deserve. Our Customer Service Team is available Monday through Friday from 8:00 AM (PST) to 5:00 PM (PST) to assist you with your laboratory testing needs. In addition to this coverage, our Medical Director and Laboratory Manager are available for consultation during laboratory business hours.
Logistics and Shipping
SCL has a dedicated Logistics and Shipping team to fill any supply request you may have. We provide all necessary equipment and supplies to ensure proper collection of every specimen. Our team works closely with our overnight courier service to ensure that the integrity of every specimen is not compromised during transit to the laboratory. This team is available to address any shipping concerns or problems.
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Licenses & Accreditations