Connecting diagnostics, connecting information, connecting the dots Over

Over the past few years Inverness Medical has steadily expanded and we have added new products and healthcare services to our portfolio, resulting in a multitude of well known brands including BinaxNOW®, Clearview®, Determine® and Triage®. In order to realign with our strategy, to bring healthcare closer to the physician and patient, the company has decided to bring most of our

Over the past few years Inverness Medical has steadily expanded and we have added new products and healthcare services to our portfolio, resulting in a multitude of well known brands including BinaxNOW®, Clearview®, Determine® and Triage®. In order to realign with our strategy, to bring healthcare closer to the physician and patient, the company has decided to bring most of our products and services together under a single global brand, creating an identity that is easily recognisable to our customers - Alere

“Alere” is a Latin verb meaning to nurture, to care for, or to support. It reflects our focus on delivering people-centered, smart and productive healthcare solutions. As a company focusing on improved quality of patient care, the name “Alere” clearly conveys our goals. The range of AlereTM innovative products and services will allow healthcare decisions to be taken at the point-of-care and cover a range of health areas including infectious diseases, cardiology, oncology, drugs of abuse and women’s health.

Over the coming months you will see brands including BinaxNOW®, Cholestech LDX®, Clearview®, Determine®, Panbio® and Triage® transition into a single global brand, AlereTM.

Cardiology

Alere has recently announced the launch of three new next generation products; Troponin I - a single-analyte, improved sensitivity Troponin I (TnI) test, Cardio2 - a two analyte panel consisting of the new Troponin I and BNP as well as Cardio3 - a three analyte panel consisting of the new Troponin I, BNP and CK-MB. These improved tests allow for earlier detection of even lower levels of TnI which improves outcomes and benefits the patient, the hospital, the physician office laboratory and the cardiologist.

These new tests represent the further evolution of Alere’s market leading Triage cardiac testing solutions. These test utilize enhanced TnI sensitivity enabling measurement down to the 99th percentile, a recommendation found in emergency department, cardiology and laboratory guidelines.

By offering this improved sensitivity troponin assay on panels that simultaneous test other cardiac markers at the Point of Care, these products will allow emergency physicians to make better chest pain/shortness-ofbreath patient disposition decisions much more rapidly. When used in a rapid serial draw algorithm, the panel results can identify healthy patients earlier, allowing them to go home sooner and physicians to focus their time on only those patients in greatest need. All three products are designed for use on the Triage Meter.

“Alere continues to demonstrate its commitment to improving patient outcomes through the development of ever more powerful tools for the Point of Care”, said Tom Parenteau, Senior Director of Global Product Marketing. “We’re extremely excited to bring such innovations to the cardiovascular diagnostics market, ones which enable physicians to make faster and better informed decisions about their chest pain patients”.

The products bear the CE Mark, which expresses conformity with the requirements of the European IVD Directive and allows distribution within the European Union. The tests are now available for commercial sale in Europe, Australia and New Zealand and will soon be available in many other countries around the world. A timeline for US availability will be established shortly.

Blood-borne Pathogens

Alere has also recently launched the new Panbio® Dengue Early Rapid immunochromatographic test for the early detection of dengue infection. Designed for use in conjunction with other dengue serology tests, the Dengue Early Rapid test can help to diagnose active dengue infection from the very first day fever appears. In facilitating early diagnosis, therapy and monitoring can begin much earlier, reducing the risk of severe complications such as dengue hemorrhagic fever (DHF) and dengue shock syndrome (DSS).

Detecting dengue NS1 antigen in serum, the Dengue Early Rapid test is able to provide a specific diagnosis of dengue infection in 15 minutes following an easy three step procedure. This is especially valuable in areas where diagnosis could be confounded by serological cross reactivity. There are four distinct dengue virus serotypes (DEN -1, -2, -3, -4) which are immunologically related and can all cause dengue fever. Although related, the four serotypes do not provide cross-protective immunity against each other, resulting in patients in endemic regions often having more than one infection during their lifetime. The risk of DHF rises substantially with second or subsequent infections, further emphasizing the need for early diagnosis that enables early treatment and care.

Endemic in 124 countries, the dengue virus is carried and transmitted by mosquitoes. Typically, dengue fever is a non-fatal febrile illness characterized by fever, muscle pain, headache, and nausea and vomiting lasting 5-7 days. The more severe manifestations of the disease, dengue hemorrhagic fever and dengue shock syndrome, can however be fatal if not identified and therapy administered in the early stages

For more information about Panbio® Dengue from Alere, please visit: www.panbiodengue.com

HIV Diagnostics

One major area of focus for us at Alere is HIV infection. HIV remains an important public health issue that continues to demand constant evolution of testing technologies and testing algorithms, as well as sustained funding and involvement of laboratories.

Combined HIV antigen and antibody tests (4th generation) enable earlier detection of HIV infection than that afforded by antibody-only-tests (3rd generation). Rapid 4th generation screening tests designed for use at the point of care, have not been commercialized until now. The Alere Determine HIV 1/2 Ag/Ab Combo immunochromatographic rapid test enables simultaneous differential detection of the HIV-1 p24 antigen, as well as antibodies to HIV-1 and HIV-2 in human serum, plasma or whole blood.

Compared to 3rd generation assays, Determine HIV 1/2 Ag/Ab Combo improves upon the detection of HIV infection by detecting the presence of the viral antigen before the appearance of antibodies. Due to separate signals for HIV-1 p24 antigen and HIV antibodies, the test enables rapid detection of acute infection cases. Moreover, Determine is engineered in a robust and easy-to-use format for performance anywhere in the world, including areas where well equipped laboratory infrastructures are limited.

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