Profile: Alere Inc (ALR.N)

Alere Inc. is engaged in developing capabilities in near-patient diagnosis, monitoring and health management. The Company’s products and services, as well as its new product development efforts, focuses on cardiology, infectious disease, toxicology, diabetes, oncology and women’s health. The Company operates in three segments: professional diagnostics, health management and consumer diagnostics. In February 2013, it acquired Epocal, Inc.

In December 2011, the Company acquired Method Factory, Inc (doing business as, Wellogic). On November 23, 2011, the Company acquired Arriva Medical LLC (Arriva). On November 1, 2011, it acquired Axis-Shield plc (Axis-Shield). In November 2011, it acquired 1 Medical Distribution, Inc. On October 3, 2011, it acquired Avee Laboratories Inc. In October 2011, it acquired Mahsan Diagnostika Vertriebsgesellschaft mbH and Medical Automation Systems Inc. In September 2011, the Company acquired Abatek Medical LLC and Forensics Limited. In August 2011, it acquired Laboratory Data Systems, Inc. In July 2011, it acquired Drug Detection Devices, Inc. and Colibri Medical AB. In May 2011, the Company acquired 80.92% interest in Standing Stone, Inc. In February 2011, the Company acquired Alere Connected Health Limited. In March 2011, it acquired Bioeasy Diagnostica Ltda. In January 2011, it acquired 90% interest in BioNote, Inc. and Pregnancy.org, LLC.

Professional Diagnostics

Professional diagnostics are designed to assist medical professionals in both preventative and interventional medicine, and include testing and monitoring performed in hospitals, laboratories and doctors’ offices and, increasingly, patient self-testing, which it defines as testing or monitoring performed at home under the supervision of a medical professional. Within professional diagnostics, the Company focuses on point-of-care, rapid diagnostic testing and health monitoring and the developing patient self-testing market. The point-of-care market for rapid diagnostic products includes all areas where a patient is assessed or diagnosed, including hospitals, laboratories, physician offices, specialized mobile clinics, emergency rooms, rapid-response laboratories and patient health screening locations. The Company’s professional diagnostic products include point-of-care and laboratory tests sold within its focus areas of cardiology, infectious disease, toxicology, diabetes, oncology and women’s health.

The Alere Triage system consists of a portable fluorometer that interprets consumable test devices for cardiovascular conditions, as well as the detection of certain drugs of abuse. Alere Triage cardiovascular tests include Alere Triage BNP Test, Alere Triage NT-proBNP, Alere Triage Cardiac Panel, Alere Triage CardioProfilER Panel, Alere Triage Profiler Shortness of Breath (S.O.B.) Panel, Alere Triage Cardio3, Alere Triage Cardio2, Alere Triage Troponin I, Alere Triage D-Dimer Test and Alere Triage NGAL. The Company’s Alere Cholestech LDX System is a point-of-care monitor of blood cholesterol and related lipids, which is used to test patients at risk of, or suffering from, heart disease and related conditions. The Alere Cholestech LDX System provides results in five minutes per test cassette.

The Company’s Alere INRatio System is a hand-held blood coagulation monitoring system for use by patients and healthcare professionals in the management of warfarin. The Alere INRatio System measures prothrombin time/ international normalized ratio (PT/INR). The Alere INRatio System is 510(k) cleared by the Food and Drug Administration (FDA) for use by healthcare professionals, as well as for patient self-testing. The Company also sells the Alere INRatio2 System. It also distributes the enterprise point-of-care (epoc) Blood Analysis System for blood gas and electrolyte testing pursuant to an agreement with Epocal, Inc. (Epocal). The epoc platform is a point-of-care analysis system, which provides wireless bedside blood gas and electrolyte measurement testing solutions. The Alere Heart Check System provides a reading of B-type natriuretic peptide (BNP) in 10 minutes using a fingerstick sample.

The Company also sells disposable, lateral flow rapid diagnostic tests for d-dimer and troponin I under its Clearview brand. The Company develops and markets a variety of point-of-care tests for influenza A/B, respiratory syncytial virus (RSV), strep throat, pneumonia, C. difficile, infectious mononucleosis, human immunodeficiency virus (HIV), herpes simplex virus (HSV-2), hepatitis C (HCV), hepatitis B (HBV), malaria, lyme disease, chlamydia, H.pylori, rubella and other infectious diseases. As of December 31, 2011, its tests for infectious disease were sold under brand names that include Alere, Alere Determine, Acceava, BinaxNOW, Clearview, DoubleCheckGold, Panbio, Standard Diagnostics, TECHLAB and TestPack.

Its tests for infectious disease are sold under brand names that include Alere, Alere Determine, Acceava, BinaxNOW, Clearview, DoubleCheckGold, Panbio, Standard Diagnostics, TECHLAB and TestPack. The Alere CD4 Analyzer is the point-of-care cluster difference 4 (CD4) platforms, which measures CD4 counts. In addition to point-of-care products, the Company also offers a line of indirect fluorescent antibody (IFA), assays for over 20 viral, bacterial and autoimmune diseases. It is the United Sates distributor of the AtheNA Multi-Lyte Test System. Its products include tests to detect alcohol, as well as various device platforms for the detection of the illicit and prescription drugs of abuse: amphetamines/methamphetamines, cocaine, opiates, phencyclidine, tetrahydrocannabinol, acetaminophen, barbiturates, benzodiazepines, methadone, propoxyphene and tricyclic antidepressants, using urine and, for some applications, saliva, hair and other body fluids.

The Company’s rapid toxicology tests are sold primarily under the brands Alere Triage, Alere iScreen, Concateno and SureStep. The Alere Triage TOX Drug Screen panel sold for use with its Alere Triage MeterPro system detects the presence of many of the illicit and prescription drugs. It is used in hospital and clinical testing as a laboratory instrument to aid in the detection of drug abuse. Its Drug Detection System (DDS), is an on-site saliva drug detection system utilized in roadside testing, which displays results for the presence of two drugs. The Company also offers laboratory-based testing services throughout Europe under the name Concateno and in the United States under the names Alere Toxicology Services, Inc. (Alere) Toxicology, and Redwood Toxicology Laboratory, Inc., (Redwood).

The Company, through Redwood, offers laboratory testing services to multiple domestic clients, including law enforcement agencies, penal systems, insurers and employers in the United States. The point-of-care products of Axis-Shield include the Afinion Analyzer System and the NycoCard System. The NycoCard System includes tests for C-reactive protein (CRP), glycated haemoglobin (HbA1c) and U-Albumin. The test for U-Albumin is used for early identification of renal disease in patients with diabetes or hypertension. The Company is a supplier of diabetic testing supplies, including blood glucose monitors, test strips, lancets, lancing devices, and control solution, as well as other related medical supplies in the United States. The Alere NMP22 BladderChek Test is an assay, performed on a single urine sample that detects elevated levels of NMP22 protein.

The Company also offers the Alere NMP22 Test Kit, an enzyme-linked immunosorbent assays (ELISA) test designed to detect elevated levels of NMP22 protein. Its pregnancy tests are generally urine-based, CLIA-waived rapid tests in dipstick or cassette format. The Company’s women’s health products also target diseases or conditions, such as pre-eclampsia, rubella, pre-term labor and premature rupture of membrane. Additionally, it offers bone therapy (osteoporosis monitoring). The Company also markets a portfolio of tests for sexually-transmitted diseases. Its women’s health products are sold under its Alere, Acceava, Clearview, Osteomark, Sure-Step and TestPack brands.

Health Management

Health management segment provides programs and services focused on wellness, disease and condition management, productivity enhancement and informatics. The Company provides services supporting home INR testing. As of December 31, 2011, its health management business was principally conducted in the United States. The Alere Disease Management (Chronic Care) Program provides technology-enabled, evidence-based solutions for managing chronic and high-cost conditions, improving clinical outcomes and reducing healthcare costs. It offers a personal health support model of care. The DayLink Monitor records a participant’s weight and/or blood glucose, as well as answers to questions regarding their symptoms. The Alere Disease Management Program assists individuals with the chronic diseases or conditions, which include asthma, coronary artery disease, chronic obstructive pulmonary disease, diabetes, heart failure, pain, weight management and depression. In addition, it also offers Complex Care Management for participants.

The Company’s Women’s and Children’s Health division delivers a spectrum of obstetrical care services, ranging from a risk assessment to identify women at risk for pregnancy complications to a neonatal program for early infant care management. It delivers telephonic and home-based nursing services that support improved clinical outcomes. Wellness Solutions is a suite of integrated wellness programs and resources designed to help organizations reduce health risks and improve the health and productivity of their employees and health plan members, while reducing healthcare-related costs. Wellness programs include screening for risk factors associated with diabetes, cardiovascular heart disease, hypertension and obesity; screening for high-risk pregnancies and assessments of health risks for broad populations. The Company also offers services designed to support anticoagulation management for patients at risk for stroke and other clotting disorders who can benefit from home INR monitoring.

The Company’s Alere Home Monitoring business assists patients in acquiring home INR monitors, including its Alere INRatio2 monitors, and seeking Medicare reimbursement and insurance coverage, while providing physicians with a solution for incorporating home INR monitoring into their practice. The Company’s CoagNow program includes its Face-2-Face patient training model, which utilizes experienced nurse educators, patient scheduling, collection and reporting of home testing results to the physician and CoagClinic, its Web-based application, which provides healthcare professionals with real-time access to patient information. The Alere Oncology Program is the cancer management program in the United Sates. The Alere Oncology Program manages adults diagnosed with any cancer that requires treatment beyond a single surgery and includes services for over 42 different tumor types and over 200 stages of cancer. Cancer continues to challenge employers and health plans as they search for tools to manage this condition among their population.

The Company’s Alere Wellbeing business specializes in Web-based learning and phone-based cognitive behavioral coaching to help employers, health plans and state governments improve the overall health and productivity of their covered populations. The Company’s technology solutions provides employers and health plans with a portal or front door to its continuum of healthcare services and allow individuals to create a on-line record of their personal healthcare data that is compliant with the requirements of the Health Insurance Portability and Accountability Act (HIPAA), and its regulations. Its Apollo technology platform provides the framework and supporting infrastructure for a series of enhancements to Alere’s services. The Company also offers health information exchange solutions, care coordination software solutions and electronic health record (HER), technology.

Consumer Diagnostics

The consumer diagnostics segment consists primarily of manufacturing operations related to the Company’s role as the manufacturer of products for SPD Swiss Precision Diagnostics (SPD), its 50/50 joint venture with The Procter & Gamble Company (P&G). SPD has operations in the worldwide over-the-counter pregnancy and fertility/ovulation test market. As part of the SPD joint venture, it entered into a finished product purchase agreement, pursuant to which the Company manufactures and sells to SPD substantially all of the consumer diagnostic products which it sells. The Company also entered into certain transition and long-term services agreements with SPD, pursuant to, which it provides certain operational support services to the joint venture.

The Company’s other consumer diagnostic products consists of its First Check brand of over-the-counter drug tests for at-home testing for up to seven illicit drugs and five prescription drugs, as well as First Check brand over-the-counter tests for cholesterol monitoring and colon cancer screening. It also sells Balance Activ Vaginal Gel directly to consumers and health care professionals for the effective treatment of bacterial vaginosis without antibiotics.

The Company competes with Becton Dickinson, Abbott, Siemens, Beckman Coulter, Johnson & Johnson, Roche, Abaxis Medical Diagnostics, Nexus Dx, INOVA Diagnostics, DiaSorin, Qiagen Diamedx, Bio-Rad Laboratories, Tosoh Corporation, Liberty Medical, CCS Medical, Simplex Medical, AmMed Direct, United States Medical Supply, Sanare, Immuno Concepts, Trinity Biotech and Meridian Biosciences.