2020 has really been a year that doesn’t quit, hasn’t it? The dangerous part of COVID-19 has been how rapidly it has overwhelmed our healthcare system, in particular, how it has affected cancer patients and their treatment. According to Cancer Network, part of Oncology journal, the COVID-19 pandemic has alarmingly resulted in health care workers’ priorities changing to control, diagnose and treat COVID-19 patients, instead of continuing oncology diagnostics initiatives. As a result, standard cancer screenings for say, breast or colorectal cancer dropped by over 85% through May 2020. New cancer diagnoses reduced by over 65% through April 2020. What does that mean in the long-term? Long term ramifications are that this will increase the late-stage cancer patient numbers, and eventually decrease survival for these patients. Prior to the COVID-19 pandemic, the US cancer statistics had continued to improve over the last few decades including a 25% drop in cancer mortality over the past 25 years.

From 1991-2016, the overall cancer death rates dropped continuously to 27%, i.e. ~ 2.63M fewer deaths from cancer versus if the rates had remained at peak. But while the racial gap in cancer mortality is reducing, preventable cancers have been rising, especially when comparing affluent to poor countries in female cervical or male lung/liver cancers (2-fold for cervical, 40% higher for the latter, 2012-16). Hard to believe that the pandemic has been with us for nearly a year, and we now know that it’ll be a monumental task to reclaim the progress and get back to our mission, which is to lower cancer deaths, and improve on oncology diagnostics. To put it simply, you can’t fix it, if you can’t detect it. And you can’t detect it, if the patients don’t get tested.

Pharma, diagnostics groups and CROs have worked simultaneously to anticipate COVID-19-related hurdles as it relates to clinical trial participation along with monitoring and sample collection as part of those trials. According to a Lancet August 2020 article, the effect of COVID-19 has been enormous, with thousands of trials—around 80% of non-COVID-19 trials—being stopped or interrupted. In September 2020, the FDA issued its guidance during COVID-19 which emphasized the need to capture information on the case report form re: missing data, tele-visits, or missing protocol-specified information including discontinued trials. According to FDA guidance, any drug trial should now include an understanding of SAEs (severe adverse effects) as associated with COVID-19 in trial participants in a randomized controlled trial with a control arm.

NeoGenomics Laboratories, Inc. has been working with the top global pharmaceutical companies, supporting CDx (companion diagnostics) and early discovery/translational, Phase I/II/III trials. While our clinical testing team continues to test COVID-19 patient samples as part of the EUA offer, our pharma division works with pharma companies, advising and assisting in clinical test proposals, along with guidance on data collection, interpretation and submission for regulated trial studies. 2020 may be the year of COVID-19, but CROs like NeoGenomics has been the go-to group for pharma trials to apply the COVID-19 guidance to FDA trials and to offer strategic solutions on oncology trials in a pandemic.

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About Madhu Ghosh, PhD

Vice President, Strategic Alliances & Projects

About Madhu Ghosh, PhD

Vice President, Strategic Alliances & Projects

Madhu brings a wealth of experience to successful team leadership in strategic alliance management, P/L business unit leadership and IVD and CDx product development for in excess of 20 years spent in molecular diagnostics and assay development with a focus on NGS, real-time PCR, multiplex PCR, oncology and infectious disease diagnostics. Prior positions include Senior Director, Strategic Accounts and Global Strategic Partnerships, whilst at Thermo Fisher Scientific, VP positions held at Althea Dx and senior leadership tenures with Qiagen and Enigma Diagnostics.

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