What You Will Learn - What are the marketed patient self-testing
devices for measuring and monitoring anticoagulation drug therapy?
announced today that CoaguChek XS Personal (specially controlled medical device/medical equipment requiring specialist maintenance and management), a coagulation analyzer for patient self-testing
approved in Japan on July 27, 2012, has received reimbursement approval from Japan s Ministry of Health, Labor and Welfare for use in the self-testing of patients fitted with a Nonpulsatile Left Ventricular Assist System (LVAS) and will be launched in Japan on September 25.
For example, Patient Self-Testing
(PST) for PT/INR can cost $2,500 or more for the test device, plus $10-20 per strip/cartridge or disposable.
Do not overlook the growth of point-of-care testing, which includes patient self-testing
and home testing.
This good performance by patient self-testing
of their international normalized ratio (INR) suggests that "home self-testing is an acceptable alternative to high-quality clinic care and may be preferable when patient access [to a clinic] is difficult," Dr.
Roche Diagnostics stated that the acquisition will allow it to expand its immunochemistry business from human diagnostics into life science research and development, patient self-testing
, veterinary testing, drug discovery, drug development and clinical trials.
Avocet Medical received prior FDA clearances for the AvoSure(TM) PT Pro+ for healthcare professional point-of-care use and the AvoSure(TM) PT for patient self-testing
Results come just one month after the American College of Chest Physicians (ACCP), which establishes treatment practices and standards of care, released clinical evidence in support of patient self-testing
over usual outpatient INR monitoring (ACCP, 2012, p.
Based on end users, the immunoassay market is segmented into hospitals, laboratories, blood banks, academic research centers, pharmaceutical companies, CROs, and biotechnology companies, and others (physicians' offices, patient self-testing
, and ambulatory centers).
Point-of-care Prothrombin Time measurement for professional and patient self-testing
While still a small percentage of all patients, as demographics and awareness drive increases in the diagnosed incidence of underlying conditions, patient self-testing
for OAT will increasingly migrate from caregiver facilities and into homes.
Thus, integrating lab-on-a-chip with smartphones, revolutionizing point-of-care testing and decentralized testing, and introducing more patient self-testing
products and devices are important for diagnostic test developers to taste success.