Lab-developed tests were controversial before the COVID-19 pandemic, and there was attempts at regulating them more in the United States. Then came a massive infectious disease threat for which lab developed tests were essential. The sudden onset of a disease for which there were no existing test products, so labs had to develop their own. […]
The landscape of COVID-19 testing has been rapidly evolving. New products and services are continually being introduced, and regulatory approvals have been growing and expanding to include more types of tests, samples, and sample collection methods. With the sudden global demand and governments loosening requirements during the crisis, there has been an unprecedented flood of […]
Companion diagnostics are rising to the forefront of pharmaceutical development and treatment. Companion diagnostics increase the probability of clinical success by identifying patients with the presence of biomarkers or disease-specific therapeutic targets that can dramatically improve outcomes. The COVID-19 pandemic has gripped the world and continues to be a major area of research and development […]
In Kalorama Information’s Emerging Infections Testing report (https://kaloramainformation.com/product/emerging-infectious-disease-diagnostics-markets-and-trends/) , we discussed Chagas. Chagas disease is named after the Brazilian physician Carlos Ribeiro Justiniano Chagas, who discovered the disease in 1909. Chagas disease (Trypanosoma cruzi, known as kissing bugs) is also referred to as American trypanosomiasis. It is endemic throughout Mexico, and Central and South America, and is caused […]
The fast spread of COVID-19, a respiratory condition, has healthcare systems focused on other diseases that could spread using the same method. Kalorama Information’s Emerging Infectious Disease Diagnostics report: (https://kaloramainformation.com/product/emerging-infectious-disease-diagnostics-markets-and-trends/) details multiple types of viruses that are being tracked worldwide, many that have jumped from developing nations to developed ones. These are some of the […]
The FDA approved BioFire FilmArray COVD-19 test, as well as Mesa Biotech’s Accula. Both can bring a COVID-19 diagnosis to the point of care where testing is most needed. BioFire’s Film Array has thousands of placements. Accula is a hand-held test.
We projected in Kalorama’s mPOC market study that molecular point of care ( mPOC ) would lead the fight in meeting the demand for COVID-19 testing with accurate and fast results. Lab staff is at a premium, hospitals are taxed, and testing needs to happen where it can be useful to isolate patients. We suggested that […]
Demand for testing has gone from a healthcare industry topic to a national crusade in weeks with the onset of COVID-19. High-throughput tests have been approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. for the detection of SARS-CoV-2, the virus behind the disease. But for true intervention in doctors […]
Not since the Swine Flu epidemic of 2009 has there been this amount of emphasis on vaccines and vaccine development. This new infectious disease threat with no anti-viral, nor vaccine is causing significant concern among healthcare providers, governments and the public. Last-resort measures such as school closings and curfews in place in the United States […]
Major IVD vendors, especially those common in reverse transcription PCR (RT-PCR), went right to work in the recent coronavirus outbreak. This as the FDA announced plans to make emergency test deployment easier. The recent novel coronavirus, responsible for thousands of infections and over 170 deaths in the Hubei province in China at the time of […]
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