Diaceutics Regulatory News (DXRX)

Cancer Testing and Diagnosis Suffers Sharp Downturn, finds Diaceutics

- Diaceutics data analytics shows 31% drop in the number of newly-diagnosed patients with lung cancer

- Data also shows decrease in the number of colorectal, breast and ovarian cancers patients diagnosed

- 14% drop in newly-diagnosed patients with acute myeloid leukemia

- Insights based on real-time information from Diaceutics' data lake based in the US

Parsippany, New Jersey, 29 April 2020 - Diaceutics PLC, (AIM: DXRX), the precision diagnostic commercialization company, today announces research results from its COVID-19 oncology tracker, which shows the impact of the crisis on cancer testing and diagnosis in the US. The analysis, based on real-time data taken from the organization′s data lake, shows that there has been a sharp downturn in both biomarker testing and cancer diagnosis rates between February and March of this year.

The figures, which have been tracked monthly since January 2019, provide an insight into the impact that COVID-19 and the subsequent lockdown measures being implemented across the United States are having on cancer patient care. Diaceutics found that compared to the month of February 2020, March saw a 31% drop in the number of patients being diagnosed with lung cancer. Testing rates for related biomarkers also decreased, with reductions ranging between 7% (KRAS) and 13% (EGFR). With regard to EGFR, Diaceutics estimates that there were nearly 4,000 fewer tests performed in March alone when compounding the reduced number of patients diagnosed and reduction in testing rates.

Diaceutics' COVID-19 oncology tracker also revealed a 14% drop in the number of new patients diagnosed with colorectal cancer during that same time period. The insights show that testing rates for biomarkers related to this form of cancer decreased as well. BRAF was down by 9%, while MSI/MMR was down by 8% and RAS was down by 6%. In the hematological setting, there was a 14% drop in newly-diagnosed patients with acute myeloid leukemia between February and March, with FLT3 (12%), IDH1 (11%) and IDH2 (12%) testing rates all dropping.

Diaceutics found that the number of newly-diagnosed breast cancer and ovarian cancer patients decreased by 8.4% and 8.6% respectively during this period.

The information upon which these findings are based is a representative dataset from Diaceutics′ data lake, which includes community, commercial and academic laboratories. Diaceutics defines newly-diagnosed cancer patients as those who have undergone a biopsy and surgical pathology testing and have not been recorded in the company's database previously.

Jordan Clark, CCO, Diaceutics, said: "These insights highlight the devastating impact that COVID-19 is having on cancer patients, from both a social distancing and healthcare system capacity viewpoint. Our research shows that laboratories are receiving fewer samples and hospitals are performing fewer biopsies. In fact, one community hospital laboratory reported that molecular oncology testing had slumped by 25%.

"Of course, the downturn in rates varies across the different types of cancer, with lung cancer being the worst affected. We suspect that this is because COVID-19 is a respiratory disease, so the symptoms that patients would normally consult their doctor about are potentially being mistaken for the novel coronavirus.

"On the other hand, in the case of acute myeloid leukemia, patients tend to be very sick by the time of diagnosis and need to be immediately hospitalized, so these people are more likely to enter the healthcare setting despite the pandemic.

"The reality of the situation is that fewer people are going for regular screening, or attending medical appointments to get symptoms checked out. In addition, we have seen social distancing and repurposing of labs' resources to tackle COVID-19 testing impact their ability to process oncology testing. This means that fewer people are getting diagnosed and therefore tested for specific biomarkers. Optimal companion diagnostic testing is vital for getting precision medicine therapies to as many patients as possible. Our research shows that COVID-19 is having a detrimental impact on the already fractured testing ecosystem, which means that even more cancer patients are missing out on getting the treatment that is right for them at the right time.

"While this data relates to the US, the COVID-19 pandemic is a global issue so there is no doubt that the same trends are emerging elsewhere and that this decline will continue in the weeks to come."

Enquiries:

Note to the editor:

The COVID-19 oncology tracker draws on real-time data from labs that Diaceutics has agreements with and includes claims data from both commercial and public payors. Within this data, Diaceutics tracks the patient testing journey from diagnosis to advanced biomarker testing.

To determine the cancer diagnosis rates, Diaceutics uses relevant ICD and procedures codes to identify a patient population which is then normalized to the National Cancer Institute's incidence rates within its Surveillance, Epidemiology, and End Results program. To determine the biomarker testing rates, the company compares the N of diagnosed patients vs those who got biomarker testing, using claims data and data from their lab network.

The numbers Diaceutics have tracked in the last month offer a window into the impact lockdown rules and fears over SARS-CoV-2 infection may be having on the US health system's ability to diagnose new cancer patients.