Could COVID-19 Influence LDT Regulation?

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. […]

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As COVID Testing Expands Rapidly, Recommendations and Consenus Taking Shape

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 […]

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COVID-19 Has Small Negative Impact on Important Companion Diagnostic Testing, Report Finds

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 […]

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Chagas: Opportunity for Testing Companies as US Army, CDC Get Involved

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 […]

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COVID-19 Diagnostics Blog: Labs Must Remove Faulty Kits; Hundreds of Tests on The Market, U.S. Labs Mostly Use Ten

Hundreds of Tests on The Market, U.S. Labs Mostly Use Ten

As the COVID-19 crisis surfaced in the United States, molecular diagnostic manufacturers went to work with new RT-PCR testing kits.  There have been hundreds of tests on the market receiving EUAs from the Food and Drug Administration, but a survey from the Association of Molecular Pathology demonstrated that only a few are used by laboratories.  As part of its survey: https://www.amp.org/advocacy/sars-cov-2-survey/ labs were asked their top ten testing methods.   Among them: Abbott m2000, Roche cobas were the top two vendors in most labs’ top tens.

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Six Other Respiratory Conditions Healthcare Systems are Watching

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 multpile types of viruses that are being tracked worldwide, many that have jumped from developing nations to developed ones.  These are some of […]

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Coagulation Tests Find Use in COVID-19, New Anticoagulants

Coagulation is a complex process in which multiple enzymes and proteins regulate blood flow and clot formation. Coagulation (clot formation), fibrinolysis and platelet aggregation are a part of this process. Fibrinolysis refers to the breakup of blood clots. It is a normal body process that keeps naturally occurring blood clots from growing and causing problems. Anticoagulant drugs help prevent blood platelets from sticking or clumping together, reducing the likelihood that arteries will be blocked by a clot, leading to a stroke or heart attack.

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Drug Discovery Outsourcing – COVID-19 has Mixed Effect

Drug discovery is a high-cost, risky business because only a fraction of the therapeutic targets selected for study will actually yield products that achieve regulatory approval by the U.S. Food & Drug Administration (FDA) or other global regulatory agencies. The average drug can take 10+ years to progress from the discovery phase to the clinic, […]

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Reading The Tea Leaves: Limited Q1 Results Speak Volumes About the Future

While only two weeks of the first quarter of 2020 could truly be said to be under the grip of the U.S. portion of the COVID-19 pandemic and associated social distancing, companies with molecular diagnostic divisions reported a variety of positive results.  Kalorama expects further growth in the sector in Q2 reports and some tail […]

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Cell Therapy Market Reaches 3.8 BN; Cancer Treatments Dominate and COVID-19 Applications Explored

Cell therapy involves the modification of human cell which are used to replace or repair damaged tissues or cells. Two areas with growing development and commercialization include chimeric antigen receptor (CAR)-T therapies and stem cell therapies. According to a recent report from Kalorama Information, the global market for cell and gene therapy in 2020 is […]

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