Philips launches handheld rapid blood test for heart attack diagnosis

Philips announced the launch of a new handheld blood test, the Minicare I-20 system, for rapid diagnosis of a heart attack at the point of care. The new test is being introduced in selected countries in Europe including the UK, Germany, the Netherlands and Belgium, with introduction in other European countries following in due course. As a result, patients with chest pain presenting at the emergency department are set to benefit from this major innovation, which Philips has recently CE marked for compliance with the European in vitro diagnostic medical devices directive. The handheld Minicare I-20 system measures the level of cardiac troponin I (cTnI), a protein that is excreted by the heart muscle into the blood following a heart attack. It delivers test results, comparable with those obtained by laboratory testing, in less than 10 minutes near the patient, reducing the time for a physician to decide on the appropriate treatment pathway.

  

The Minicare I-20 system is the latest innovation to come out of Philips’ global R&D and new business development programs in the area of point-of-care testing and monitoring applications for the hospital and the home. It consists of a connected handheld analyzer, dedicated software, and a single-use disposable cartridge containing an application specific test based on Philips’ proprietary biosensor technology.

“The commercial launch of the Minicare I-20 system for cardiac troponin I testing represents a major milestone for us,” said Marcel van Kasteel, CEO of Handheld Diagnostics at Philips. “I am convinced that we will be able to make a real difference for patients and care providers. Minicare I-20 is designed to help care providers reduce both the time-to-treatment and time-to-discharge of patients, thereby helping to reduce crowding in emergency departments and improve the utilization of hospital resources.”

“Blood samples are usually analyzed in the hospital laboratory, and it can easily take more than an hour to get the result back to the emergency department physician,” said Dr. Paul Collinson, Consultant Chemical Pathologist at St George’s University Hospitals NHS Foundation Trust (UK). “Point-of-care testing can significantly help to reduce the turnaround time.”

The Minicare I-20 was tested in real-life acute care settings within the European Lab2Go project, a consortium of European hospitals. The study showed the potential of Philips Minicare cTnI system to accurately measure cTnI values, near the patient in the emergency department, with a turnaround time of less than 10 minutes.

A press release can be found from Philips website by following this link.

POC osteoporosis diagnosis instrument also available in USA

Bone Index Ltd. has received 510(k) clearance from the Food and Drug Administration (FDA) for the Bindex® point-of-care instrument to help in osteoporosis diagnosis.

 

Osteoporosis, a very underdiagnosed disease, is responsible for two million broken bones every year in the USA. These fractures translate into costs totaling about 19 billion dollars. Experts forecast that by 2025, the costs due to fractures will rise to 25.3 billion dollars. Currently, one of the biggest challenges in osteoporosis management is the low availability of diagnostics since bone density scans are mostly performed in hospitals with large DXA X-ray machines that entail high costs.

Bindex® measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA. Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.

"The clearance process with the FDA was straightforward despite the novel approach introduced with Bindex. The technique is based on extensive clinical evidence, and with the effectiveness of Bindex, the current care of osteoporosis can be significantly improved," says Bone Index's CTO, Dr. Janne Karjalainen.

"A recently published article* in Osteoporosis International presents an approach to how the international fracture risk calculator (FRAX®) and the Bindex® test can be used together in identifying patients in need of medication. This is extremely important because an estimated 75% of osteoporosis sufferers are undiagnosed and without the treatment they need," says Professor Heikki Kröger, MD. The clinical validation for Bindex® has been conducted with a total of over 2,000 patients.

"Bindex technology is unique in the world. The device is pocket-sized, reliable and enables new and cost-effective diagnostic pathways for osteoporosis," says Bone Index's CEO, Dr. Ossi Riekkinen.

A press release can be found from Bone Index website by following this link.

Massachusetts General Hospital developed device for rapid diagnosis of bacterial infections

A team of Massachusetts General Hospital (MGH) investigators has developed a device with the potential of shortening the time required to rapidly diagnose pathogens responsible for health-care-associated infections from a couple of days to a matter of hours. The system described in the journal Science Advances also would allow point-of-care diagnosis, as it does not require the facilities and expertise available only in hospital laboratories.

“Health-care-associated infections are a major problem that affects more than 600,000 patients each year, more than 10 percent of whom will die, and incurs more $100 billion in related costs,” says Ralph Weissleder, MD, PhD, director of the MGH Center for Systems Biology, Thrall Family Professor of Radiology at Harvard Medical School (HMS) and co-senior author of the report. “Rapid and efficient diagnosis of the pathogen is a critical first step in choosing the appropriate antibiotic regimen, and this system could provide that information in a physician’s office in less than two hours.”

While considered the gold standard for diagnosing bacterial infections, traditional culture-based diagnosis can take several days and requires specialized equipment, trained laboratory personnel and procedures that vary depending on the particular pathogen. Emerging genetic approaches that identify bacterial species by their nucleic acid sequences are powerful but still require complex equipment and workflows, restricting such testing to specialized hospital laboratories.



The system developed by the MGH team, dubbed PAD for Polarization Anisotropy Diagnostics, allows for accurate genetic testing in a simple device. Bacterial RNA is extracted from a sample in a small, disposable plastic cartridge. Following polymerase chain reaction amplification of the RNA, the material is loaded into a 2-cm plastic cube containing optical components that detect target RNAs based on the response to a light signal of sequence-specific detection probes. These optical cubes are placed on an electronic base station that transmits data to a smartphone or computer where the results can be displayed.

More details can be found from MGH website by clicking here.

China's Sinocare Reaches Definitive Agreement to Acquire PTS Diagnostics

Sinocare Inc announced today it has signed a definitive purchase agreement with privately-held PTS Diagnostics, under which Sinocare will acquire PTS Diagnostics for up to $200 million in cash including contingent considerations of up to $90 million for the successful accomplishment of certain milestones. PTS Diagnostics is a U.S.-based manufacturer of point-of-care biometric testing devices, including the CardioChek® family of analyzers, A1CNow systems, and PTS Detect cotinine systems. The company’s manufacturing facilities are principally located in Indianapolis, IN and Sunnyvale, CA.

Shaobo Li, Chairman and CEO of Sinocare commented, “Sinocare is dedicated to the innovation of biosensor technology and has been providing high quality products and services to people with diabetes and other chronic diseases. Through continuous innovation, PTS Diagnostics has become the market leader of lipid, A1C and other important point of care biometric testing. We know Sinocare and PTS Diagnostics have a shared vision and mission to improve the quality of life for our users. We commend and respect the achievements of the PTS management team and employees, and we are confident that they will be able to continue to deliver and achieve our common goals. We will continue to grow our business and explore opportunities globally and we will provide more innovative and systematic solutions to fight chronic diseases which allow people with diabetes and other chronic diseases live better and healthier lives.”

“PTS Diagnostics has a proven track record of driving innovation and efficiency in the point of care biometric testing category. We are quite pleased and excited by the many future opportunities that now open for us as a part of the Sinocare, as together we will greatly expand our mutual global reach. We share a vision of innovation and creativity, and together we will make our various solutions available to a much larger customer base, driving action and connecting more people to improved outcomes. Our biometric connectivity and information platform, PTS Connect, continues to solve significant data management problems for healthcare professionals,” said Robert Huffstodt, President and CEO of PTS Diagnostics. “PTS Diagnostics’ core product portfolio of lipid and HbA1c testing systems also integrate well with Sinocare’s focus on glucose monitoring. Our combined company will provide unmatched access to information that will help improve diagnosis and monitoring of multiple chronic diseases. Together, our future will be centered on transforming preventative medicine, biometric testing, and connectivity by providing fast, easy, portable, and accurate medical devices and information management systems to individuals and healthcare professionals.”

Subject to the satisfaction of certain conditions, the transaction is expected to be completed within one hundred and twenty days.

Evercore is acting as exclusive financial advisor to Sinocare. J.P. Morgan Securities LLC is acting as exclusive advisor to PTS Diagnostics.