Astro Instrumentation, LLC and Immunicon Corporation Team Up to Provide Automated Breakthrough System for Cancer Detection

According to the World Health Organization, breast cancer is the most common form of cancer among women, affecting more than five million women per year worldwide. While not all cancer is treatable, a patient has a much better chance of survival when the disease is diagnosed and effectively treated in its early stages.

A new automated diagnostic device, manufactured by Astro Instrumentation, LLC (Strongville, Ohio) and Immunicon Corporation (Huntingdon Valley, Penn.) is helping oncologists in the battle against breast cancer. The CellTracks® system enables physicians to more quickly gauge a patient’s response to prescribed treatment.

Relying on CellTracks’ sophisticated cell isolation process, doctors can continually monitor circulating tumor cells in a patient with metastatic cancer throughout the treatment regimen. At the onset of treatment and every three to four weeks thereafter, the technologist can use the CellTracks system to gather critical data on circulating tumor cell counts. This information is then provided to oncologists so they can evaluate and adjust regimens accordingly.

CAT scans, by comparison, provide an image of a patient’s metastatic lesions. These scans are typically administered before the start of a new line of therapy and a follow-up after 3-4 months to assess treatment efficacy. Results from the CAT scan are very subjective because the radiologist attempts to measure the change in size of the tumors. However, CAT scans can only detect fairly large changes, so the time interval must be fairly long, which ultimately hinders a doctor’s ability to evaluate a patient’s response in the early stages of treatment.

An indispensable component of the CellTracks® AutoPrep System is a Colder Products Company (St. Paul, Minn.) quick disconnect coupling. The Colder quick disconnect resides on a bulk fluid module that contains the waste, buffer and cleaning solution supply. For medical technologists who need to change these bottles, having a leak-free coupling limits their exposure to harsh cleaning chemicals and biohazards, such as whole blood. The coupling also prevents the formation of air bubbles in the reagent lines, which could potentially affect the accuracy of the reagent delivery and the system results.

“Precise control of the waste and buffer supply is vital to the ability of the system to isolate circulating tumor cells and determine a correct cell count,” says Michael Kagan, vice president of operations at Immunicon Corporation. “Use of the Colder connection not only prevents air bubbles and leaks in the fluidic system, it also allows easier access and handling of these fluid lines by the operator.”

Colder couplings also enable technologists to quickly connect and disconnect the module with one hand when the bottles need to be changed or replaced, resulting in simplified servicing and faster maintenance of the system.

Need for Greater Accuracy and Speed Driving Demand for the Automation of Lab Equipment

In recent years, the high cost of drug development and labor coupled with the need for improved analytical procedures has led to increasing demand for automated laboratory instruments. Consequently, as medical technologists have begun moving away from the more time-consuming manual operations, they are leveraging these highly automated systems by running multiple lab tests simultaneously. The use of automated systems also has translated to more standardized results and the generation of less waste.

Looking to address this evolving trend for advanced systems, bioscience company Immunicon decided to investigate ways to automate its early CellPrep cell preparation system. The company called on Astro Instrumentation, a designer of electromechanical devices, for a solution. Working in partnership, the two companies developed the CellTracks AutoPrep System. Immunicon currently sells this system to major cancer centers and research institutions worldwide.

How it Works

The overall challenge with the system then, is to capture one circulating tumor cell from billions of cells in a tube of blood. Through the process of enrichment, the CellTracks AutoPrep System isolates and stains the cells using immunomagnetic cell capture. The CellTracks AutoPrep system adds reagents to each blood specimen and through a series of additional process steps, aspirates the unlabeled blood cells. In so doing, the sample volume is reduced from 7.5 ml to 320 ul. The resulting 320 ul volume contains a concentration of the circulating tumor cells. This final enriched sample is dispensed into a cartridge, which is scanned by the CellTracks® Analyzer II.

With the tumor cells magnetically labeled, the use of robotics correctly positions probes and moves the required magnets to allow for the magnetically labeled cells to be directed to specific locations in the sample tube and through a series of stations on the instrument, ultimately resulting in an enriched sample. The fluidic module controls fluid movement to and from the bulk fluid module that is attached to the instrument. The bulk fluids on the module are considered common reagents or supplies needed for the system to operate effectively.

“We hope that by identifying and counting the circulating tumor cells, physicians can have a better understanding of the disease status in a patient in a relatively short amount of time,” says Kagan.

Quick Disconnects are Critical for Safe, Accurate Dispensing

In the bulk fluid module, Colder quick disconnect couplings attach to three large, four-liter bottles containing the waste, buffer and cleaning solution supply. Having a leak-free connection ensures limited contact to biohazards and eliminates waste and clean-up involved with messy spills. Additional options on the Colder quick disconnect coupling include a feature called keying, which prevents the inadvertent mixing of waste and water supply lines and can assist in matching required connections.

While added features enhanced the value of the couplings, quality and reliability were the chief considerations for Astro and Immunicon when choosing components for the CellTracks AutoPrep system. For such a unique device, the companies needed components that would enable them to meet the required specifications such as chemical compatibility, ease-of-use and dependability. Colder’s quick disconnects met these requirements.

“For more than fifteen years, we have depended on Colder for a variety of applications in high-end medical instrumentation such as chemistry analyzers and urinalysis. The fact that we have never had a problem with system safety in the external fluid module attests to the reliability of Colder quick disconnects,” says Tom Harbart, director of engineering at Astro Instrumentation. “Lab automation is ultimately about bringing a greater level of consistency and efficiency to operations. With Colder couplings, we have been able to accomplish this goal.”