Changing Diagnostic Paradigms With The Revolution In Point Of Care Testing

A Story by Steveblade

The point of care testing (POCT) device in healthcare sector focuses on value rather than test volume and reimbursement issues that minimize tests to the optimal point where outcomes won't suffer whil

A recurring theme in healthcare is that the diagnostics industry is on the cusp of a major transformation that will see an evolved role for point-of-care (POC) tests that can be run at the bedside, in doctors’ offices, at pharmacies or in people’s homes. This industry tends to transform with the computing revolution rendering many types of mainframe computers obsolete, as the price of manufacturing POC tests drops and the potential for running multiple tests in miniature expands.

Shift to Self Care Diagnosis

The emphasis of care has shifted from the prevention and early detection of disease to the ability to get involved and diagnose themselves. The dominant area in POC is glucose monitoring, which requires self-monitor and diagnoses as diabetes patients needs to regularly test themselves means that the ease of access to, and functionality of, POC testing is perfectly suited to their conditions.

Portability: Trend in POCT

Trend of wearable devices , smartphones and lab-on-a-chip technology is the major factor for the recent growth in POC testing. In addition, portability and usability of these devices also means that this testing has huge potential from a humanitarian perspective. In hard-hit areas of Africa, a quicker, cheaper diagnosis of life-threatening disease could be life-changing or lifesaving for millions of people in order to see a POC test for HIV, TB or malaria from a smartphone, enabling patients to diagnose themselves �" avoiding lengthy trips to hospitals or healthcare providers. As of now, USA is dominating the POCT market, however Middle East & Africa and Asia-Pacific are the potential areas for the growth owing to the production and innovations in the healthcare sector.

Alere & Roche in Competition for POCT Market

Alere received the FDA grant for a nucleic acid-based test, that was quickly followed up by Roche’s own FDA approved Cobas product portfolio. On the basis of Poct market share, Roche, Alere and Siemens lead the way in POC market. Siemens, BD and Hologic are preparing to wade in the molecular POC market. According to the National Centre of Biotechnology Information (NCBI), in 2011 the POC testing market was around USD 15 billion and tends to grow at the rate of 4% over the forecast period.

POCT Solutions: Opportunistic Market

Much opportunity exists to create POC solutions to help minimize the time spent by nurses walking to and from centralized charting and monitoring areas. Additionally, many current systems are inconvenient and time consuming, actually putting patients at risk. Point-of-care testing at retail pharmacies can reduce the number of undiagnosed HIV patients (14% of undiagnosed HIV patients cause 33% of new infections) - leading to the reduction in new infections. The 20 minute visit is light-speeds faster than the 2-weeks needed when sending tests to established laboratories. OJ-Bio's Xtalline product range measures the biomarker C-Reactive Protein (CRP), a biomarker of inflammatory disease allowing determination of whether an infection is caused by bacteria. The test then can be used to determine whether antibiotics are required immediately at the point-of-use. It's designed to be simple enough for anyone to use.

Parallax's Target System Technology

The commercial success of the current generation of small, simple to use diagnostic devices which provide rapid results in POC applications has been limited by their inability to provide precise, highly sensitive, quantitative measurement. Parallax's Target System technology addresses these limitations by applying sophisticated immunochemical and optical methods to detect and quantify virtually any analyte present in a liquid. Development data indicates that sensitivity will be comparable to expensive and complicated laboratory-based analyzers.

Major Players: Competitive Analysis

Key vendors in this market are -Abbott Diagnostics, Alere, Roche Diagnostics, Siemens, Abaxis, Acon Laboratories, Avioq, Bio-Rad Laboratories, Cavidi, Cepheid, Chembio Diagnostic Systems, Clarity Diagnostics, Hologic, Thermo Fisher Scientific, Landwind Medical, Mindray, i-Sens, Nipro Diagnostics, Randox Laboratories, Span Diagnostics, Sysmex, Trivitron Healthcare, and URIT.

APAC Expected To Be The Largest POCT Market

APAC point of care testing market to reach USD 6.23 billion by 2024. the market has clocked revenues of USD 3.45 billion in 2016.Adoption of miniaturized technology and hospitals looking for a quicker means to reduce turnaround times for test result to reduce the patient stay in hospitals. APAC is the opportunistic market for the POCT due to the demand for the traditional care settings in order to reduce hospital stay, overcrowding of emergency room and increase speed of diagnosis of patient. In operation theatres, recovery rooms, cath labs and intensive care units POCT is preferred in order to deliver the quicker results. Glucose point of care, haematology, cardiac and pregnancy testing tends to enable the selective opportunities in APAC. Stakeholders are educating physicians about POCT being more on the perception of the medical personnel, in addition offering the rental and direct sales of product to decrease distributor and retailer costs.

Quality Diagnostics Products

Point-of-care line QDx (QDx stands for Quality Diagnostics) of DiaSys is committed to introduce technologically advanced products under its mother brand QDx. DiaSys POC products helps patients and their caregivers get timely and actionable information to achieve better patient compliance, better treatment outcomes, better health, and higher quality of care. QDx range of POC products do not replace the laboratories, rather complement the lab’s efforts by providing quick results at patient’s bedside especially for critical care test like PCT (Procalcitonin) and CTnI (Cardiac Troponin I). The HemoCue POCT solutions are used in a broad spectrum of clinical settings all over the world like hematology, diabetes, connectivity solutions, etc. EKF Diagnostics Holdings plc sold over21,500 point-of-care analyzers in 2016. Trinity Biotech plc's point-of-care revenues increased from USD 20 million in 2015 to USD 22 million in 2016, which represents an increase of 1.4%.

Monitoring Of Coagulation Abnormalities

With increasing burden on healthcare systems, care providers today are under greater pressure than ever to optimize procedures, provide cost- and time-efficient care and bring care close to the patient. The benefits of point-of-care testing (POCT) have been well documented, however POCT is still not widely implemented in hospitals. In many instances, hospitals still use central laboratories to process tests, which can impact efficiency, the length of stay of a patient as well as costs. Minicare H-300*, point-of-care hemostasis system to aid in the diagnosis and monitoring of coagulation abnormalities: In critical care settings, such as a heavy blood trauma or massive surgery, it can be crucial for the physician to know the accurate coagulation status of a patient.

Hand-Held versus Bench-Top POCT Devices

According to accreditation Canada, POCT is “any test conducted outside a lab, in a hospital, in a clinic or by a health care organization providing ambulatory care.” POCT devices are categorized into two types: Hand-Held and Bench-Top on the basis of size. With the revolution of healthcare sector, devices are synchronizing along with it. It provides with rapid results that are useful in making clinical decision by the doctor making it convenient for patients and care providers as well.

POCT Devices Types & Benefits

The POCT devices are segmented on the basis of system are as follows: Blood gas family, Cardiac, Diabetes, Urinalysis, and Informatics. Blood Gas Systems provide test data quickly with minimal operator interaction. Major application areas of POCT: self-monitoring; community testing in the pharmacy; general practice; and the emergency department. The dominant model of laboratory testing throughout the world remains the centralised laboratory in which more and more of the analytical processes are automated to enable the analysis of large numbers of samples at relatively low cost. This trend is well established in biochemistry and haematology and is now extending to other disciplines including microbiology and anatomical pathology. Point-of-care instruments vary widely and can be categorized as “transportable,” “portable,” or “handheld,” based on the format. Some are capable of testing specific analytes, while others are capable of performing an array of tests (eg, electrolytes and blood gases).

End User Analysis

In the hospitals, clinics, diagnostic labs and home care settings POCT devices are being used for immediate test results that lead to quicker decisions for earlier treatment. Critical patient results are needed in the laboratory as well as the OR, ER, ICU, critical care units and other hospital testing locations. In hospital, POCT is used in Inpatient (Operation Theater, Intensive care ward, Emergency departments, etc) as well as outpatient care (Medical Practice, House Visits, etc). While glucose monitoring and anticoagulant monitoring are commonly utilized by patient self-monitoring category.

Regional Market Scenario

North America has the largest market for POCT devices followed by Europe. However, APAC is the emerging market with the highest CAGR due to the multiple factors like growing initiatives by major players to expand the distribution network, innovation in health care, increasing patient population, and rising number of ventures among POC providers are responsible for the growth of the Asia-Pacific point-of-care device market. The market is considered evolving with growth opportunity. Developing and developed markets have scope to grow due to an ageing population worldwide. Europe POCT Device Market is expected to reach USD 10.1 billion by 2024 from USD 5.2 billion in 2016, at a CAGR of 8.6% in the forecast period 2016 to 2024. On the basis of prescription mode, the Europe point-of-care testing market is segmented into prescription based testing and over-the-counter (OTC) testing. The OTC testing is projected to witness the higher growth rate of 9.1% during the forecast period to reach a value of USD 3.98 billion by 2024. Some of the major factors driving the market for rising scope of POCT devices, advancement in technology, increasing incidence of chronic diseases, rising demand for self-testing point-of-care testing devices, decentralized laboratory testing, and technological advancements like the microfluidic lab on a chip technology. These factors increase the demand for devices such as blood glucose meter, CRP, HBA1C, Homocysteine.

Target of Major Players in Diagnostics

Top players of POCT devices are Roche, Alere, Siemens, Abaxis, Abbott, Bayer, Biosite, bioMerieux, etc. Like in IVD Category Roche is the dominant player in POCT Devices. Coagulation and glucose testing are key areas. In June 2015, Roche introduced the Cobas c513 blood glucose analyzer. It is a dedicated, high-throughput HbA1c analyzer suitable for diagnosis, monitoring and risk identification of diabetes patients.

Future of Point-of-Care Instruments and Testing

Point-of-care testing undoubtedly will take a more active role in critical care settings. It will be used more for on-site diagnostic testing and trend monitoring of patient conditions, due in part to the increasing percentage of critically ill patients in hospitals, the need for shorter therapeutic turnaround time, and bidirectional connectivity of transportable, portable, and handheld devices. While POCT may not necessarily replace centralized laboratory testing, it is becoming an important modality for improving patient care and outcomes.

Point-of-care testing services are anticipated to surpass immunizations to drive revenue [in retail pharmacies]. Pressure from payers to detect high-cost diseases early will help speed up the growth of pharmacy-based diagnostic screening services. Areas for pharmacy-based POC tests include Acute disease screening such as influenza or strep, chronic disease management and monitoring such as diabetes (blood glucose and A1C), cholesterol, HIV, hepatitis C and more and other important tests like tests for blood lead levels or genetic tests.

Coeliac disease is a lifelong autoimmune disease caused by a reaction to gluten which affects 1 in 100 people worldwide, that’s 650,000 people in the UK and 72 million worldwide. Since 2005 they have contributed around 2 million euros towards research into the fundamentals of the condition, finding out about the immune mechanism involved, the genetics, and complications like neurological problems, as well as psychological and social factors associated with coeliac disease. The development of innovative digital tools and point of care testing could offer an optimum regime for self-care.

Home Monitoring

The Diabetes Control and Complications Trial demonstrated that glucose control in type 1 diabetic patients reduced long-term microvascular complications. Normoglycemia is recommended for all diabetic patients and is best attained in insulin-treated type 1 and type 2 patients by intensive insulin therapy or 3 to 4 insulin injections per day. The dose of insulin is determined by a blood glucose value obtained by a fingerstick capillary blood specimen analyzed on a portable glucose analyzer approved for home use by the US.