LifeSign
Changing the Face of Healthcare with Point of Care Testing Solutions

Given the unpredictability of flu virus circulation and severity, accurate screening is key for delivering an effective treatment and ensuring positive patient outcomes and infection control. Viral infections are contagious and can affect the health of more than just one person; which is why identifying the cause of an infection early is integral to initiating the right treatment at the right time. Yet, too often, healthcare providers are forced to choose between accuracy and speed; there is increasing pressure for faster turnaround of laboratory results and the development of a broader menu of testing devices. With the rise of point-of-care testing solutions (POCT), however, that picture is starting to change. POCT is bringing testing closer to the patient, and results are available conveniently and quickly to the healthcare provider to expedite diagnosis and subsequent treatment. Today, several manufacturing companies are pushing the envelope to make POCT devices faster, easier, and more reliable. A maven among these is NJ-based medical diagnostic company LifeSign, which is delivering high-quality rapid point of care testing solutions to care providers worldwide. The firm’s extensive line of innovative testing products is used worldwide for the detection of medical conditions and illnesses that include infectious disease, women’s health, drugs of abuse, and cardiac markers. Roger Kang, president of the firm says, “In a time of crisis like this, where there is a rapid spread of COVID-19 across the world, a quick flu test has become very important as a screening tool. Considering the limited availability of corona virus tests, doctors can use rapid flu tests to check if a patient has flu. And, if an individual tests negative for flu, and yet exhibits flu like symptoms, the doctor can then take the necessary steps to screen for a corona virus infection.” To that end, LifeSign offers a range of in vitro rapid qualitative tests that detect infectious diseases such as flu, strep, and mono directly from nasal swab/nasopharyngeal swab, throat swab, and blood respectively. All of LifeSign’s solutions are developed and manufactured under ISO, FDA cGMP, and CE mark guidelines, and marketed and supported with the highest of quality standards by LifeSign’s team of sales, technical, and customer service professionals.

At the core of all these rapid diagnostics solutions provided by the firm is the underlying, patented lateral flow immunoassay technology. Today, LifeSign has access to over 70 FDA 510K cleared testing products, all manufactured and developed in-house by its sister company, Princeton BioMeditech Corporation (PBM). PBM was founded back in 1988 by Dr. Jemo Kang, and one of the first products the company developed and commercialized was a one-step pregnancy test that tests for the human chorionic gonadotropin hormone in a urine sample.

Today, LifeSign has access to over 70 FDA 510K cleared testing products, all manufactured and developed in-house by its sister company, PBM

It is a simple test that is over 99 percent accurate and presents the results in less than a minute. The company has since developed an array of POCT products, including a test for screening male and female fertility, drug screening tests to identify drug abuse in individuals, and an immunochemical fecal occult blood test (FOBT) to detect hidden blood in the stool. “The FOBT test is an effective screening test that can help identify precancerous polyps in the intestine,” adds Kang. In addition, LifeSign also offers cardiac marker tests that help healthcare providers diagnose congestive heart failure (CHF), cardiac ischemia, and other heart conditions associated with insufficient blood flow to the heart. These tests also help determine a person’s risk of having these conditions and monitor and manage someone with suspected acute coronary syndrome and cardiac ischemia.

What perhaps talks for itself about LifeSign is its rapid POCT products’ ease of use, accuracy, robustness, efficacy, cost-effectiveness, and quality. “The success of our products stems from our team’s expertise and experience. Every time we create a solution, we try to understand who is going to be using the product and how can we make the task easier for that individual,” mentions Kang. “We try to make sure that the tests not only meet but exceed the expectations of the person who using it.” In fact, LifeSign strives to implement feedback from customers in its products regularly. Since its inception, the firm and its R&D department has worked hand-in-hand with customers, analyzing and identifying different product options for new product development. “We’re not just making products and sending them out. We offer customers the liberty to give their input for product development. We originated as a developer of rapid diagnostic products and have continued down the same path, creating, developing, and manufacturing quality U.S. made products,” remarks Matt Lane, director of sales at LifeSign.

And LifeSign’s dedication to in vitro diagnostics doesn’t stop there. The firm also offers a wide range of support materials and educational tools— including in-person training, online videos and scientific publications—to help healthcare providers and caregivers with the product specifications and procedures. Going forward, LifeSign will continue to manufacture high-quality rapid diagnostics aligning with the growing market demand for better POCT solutions. In fact, the firm is currently developing both rapid antigen and antibody tests for coronavirus. These screening test will have the same format as LifeSign’s flu and mono tests. “If coronavirus does become more of a seasonal illness, our new test could be a very valuable tool for a healthcare professionals,” informs Kang. The firm is also looking forward to growing both internally and geographically in the coming years. Between the changing healthcare landscape and increasing demands for improved accuracy, efficiency, and productivity, LifeSign’s innovative POCT products that offer treatment decisions in minutes rather than hours are proving to be a boon for caregivers and healthcare professionals around the world.