More than four million patients in the U.S. are being treated with oral anticoagulants such as warfarin (Coumadin®) for a variety of clinical conditions such as dangerous blood clots, heart attacks, stroke, coronary artery disease, joint replacement, congestive heart failure, and cancer.
In the past, these patients had to make lab appointments to have their blood tested regularly to see if they were maintaining the proper clotting times, according to something called the Prothrombin Time/International Normalized Ratio (PT/INR). A tube of blood would be drawn using a large needle in the arm, which could be painful. And of course, this often created problems for patients who were on anti-clotting therapy in getting the bleeding stopped after the sample was taken.
Further, the sample then needed to be analyzed and the results reported to physicians before patients could be contacted and any adjustment made in their warfarin dosage.
For long-term warfarin users, lab visits typically were required every four to six weeks. This period of time was frequent enough to be inconvenient for patients, many of whom are elderly. At the same time, it was not frequent enough to ensure that patients stayed within the therapeutic range required to properly treat their medical condition.
Testing at Home or in the Doctor’s Office
On June 1st, CoaguSense Inc. — which is headquartered in Building 42840 Christy St., Suite 110 — emerged from stealth mode, with FDA approval of their groundbreaking portable, point-of-care medical system.
The CoaguSense PT/INR monitoring system is designed for home use by patients, or by physicians right in their offices, without requiring a separate trip by patients to a specialized lab. Medicare will now cover both treatment options.
With the CoaguSense system, a small finger stick is all that’s needed to produce a blood sample on a test strip. The system’s metering device then reads the sample and adjustments can be made by physicians instantly, minimizing the chance of clotting.
Talking with CoaguSense President and CEO Doug Patterson, I learned that administering anticoagulants such as warfarin or Coumadin has always carried significant risks for the medical community. “If a physician prescribes too high a level of warfarin to ensure clots don’t occur or reoccur, there’s a real risk of causing a hemorrhagic stroke due to excessive bleeding,” Patterson explained. “That could lead to a costly malpractice suit against the physician. But if too little is prescribed, then the patient will get blood clots. It’s critical the optimum therapeutic range is maintained — and that’s where our system can help.”
Christy Street Space Offers CoaguSense Extraordinary Flexibility
Founded in 2008, CoaguSense moved into 3,323 sq. ft. of space in 42840 Christy St. in early 2009. Patterson said the location in Fremont, close to the I-880 freeway, as well as services and dining in the Pacific Commons Shopping Center, was ideal for employees.
But what appealed most to Patterson was Christy Street’s flexibility to accommodate the expansion he envisioned for the company. CoaguSense just added 3,000 sq. ft. of space in the adjacent suite 112 — combining suites 112 and 110 into a single office with more than 6,300 sq. ft. That gives Patterson enough room for office purposes — and even to manufacture the test strips in a small facility that’s part of the Fremont space. Meter fabrication is outsourced.
“As a medical device company, we are certified not only by the State of California but also ISO under ISO 1345 guidelines,” said Patterson. “If we were to move, we would have to undergo the arduous certification process again. Having the flexibility to expand here at Christy Street is critical.”
This may prove even more critical going forward. Industry analysts estimate the patient self-testing market will grow by over 500% annually, from $100 million to $1 billion annually within five years!
Abbott Labs has signed an exclusive sales agreement to market the CoaguSense system nationwide. For more information about CoaguSense, visit the website. To find out more about the remaining spaces at Fremont Business Park at Christy Street, e-mail Anna Mcquillan Rose, or call her at (408) 550-4826. DRE License #01368576