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Roche Planning Additional SARS-CoV-2 Product Launches as MDx Business Soars


NEW YORK – SARS-CoV-2 products have been the saving grace for many diagnostic firms trying to weather the COVID-19 pandemic, especially as other areas of focus, such as cancer screening, have taken big financial hits.

Roche announced in its financial results Thursday that it too has felt the pinch of declining routine testing volumes, but it has been able to offset softness in its other businesses as a result the skyrocketing demand for SARS-CoV-2 tests, of which Roche has four available, two molecular and two serology. Its current offerings include high- and low-throughput PCR assays to detect the virus, and a serology antibody test.

On a conference call to discuss the earnings, Roche Head of Diagnostics Thomas Schinecker said diagnostics growth for the first half of the year was in line with expectations but noted the areas of success have shifted due to the pandemic. "The mix has been very different to what we would have expected at the beginning of the year," he said. 

Roche's usual big businesses such as centralized and point-of-care solutions, along with tissue diagnostics and diabetes care, were hit hard by the global lockdowns that led to decreases in routine testing, checkups, and non-emergency surgeries. But molecular diagnostics growth compensated for the downturn, increasing more than 100 percent in the second quarter alone as a result of the firm's PCR test portfolio, Schinecker said. In the same quarter, the virology segment of the diagnostics area encompassing high-throughput assays grew 200 percent, while the LightMix segment for low-throughput assays grew 250 percent throughout the quarter.

Continuing to respond to demand for COVID-19 testing, Schinecker said the company is investing even further into SARS-CoV-2 diagnostics and will launch four new products in the coming months – one high-throughput multiplex assay for SARS-CoV-2 and influenza, a multiplex assay at the point of care, a serology antibody test, and a rapid antibody test.

The high-throughput multiplex assay will run on Roche's Cobas 6800/8800 and will differentiate between SARS-CoV-2, influenza A and influenza B, which Schinecker said would be important as the flu season begins. The same assay will also be available as a rapid diagnostic for the Liat point-of-care instrument. Meanwhile, the firm's new Elecsys serology test will run on the Cobas e immunoanalyzers and will be a quantitative immunoassay detecting antibodies for the spike protein.

Schinecker noted that antibody tests are important for understanding immunology and prevalence and how the virus impacts patients. The new assay will be particularly significant in the context of vaccine development to monitor the level of antibodies in the blood.

Roche's first antibody test, the Elecsys Anti-SARS-CoV-2 test, is a sandwich assay for detecting antibodies to the nucleocapsid protein and looks at the neutralizing of antibodies in live cells, Schinecker said. Most likely, the two Elecsys Anti-SARS-CoV-2 tests will be used in combination to detect both kinds of antibodies using the same blood sample, he added.

Roche is also working internally to develop a rapid viral antigen test for the virus, but sensitivity is a concern, Schinecker said. Rapid antigen tests on the market have sensitivity between 80 and 84 percent, which is also where Roche's test is at, according to Schinecker. If an antigen test was launched, Schinecker said any negative result would have to be confirmed with a more sensitive PCR test, making it an inefficient choice for broad screening. 

Roche is in discussions with multiple vaccine companies who want to use the firm's antibody tests. The company also has the Elecsys IL-6 test, which identifies levels of inflammatory marker interleukin 6 in the body and can help identify COVID-19 patients at high risk of intubation. The test received Emergency Use Authorization from the US Food and Drug Administration in June.

The boom in diagnostics also led to an increase in hardware sales throughout the first half of the year, selling twice as many as normal, Schinecker said. But that boom was accompanied by higher distribution costs for the SARS-CoV-2 tests because getting products into different countries during lockdowns presented challenges. He said the company had to charter flights to ensure products made it to where they needed to go on time, since normal flights were rare.

Roche noted in its first quarter earnings call that it would focus on ramping up manufacturing capacity for both molecular and antibody testing, and company CEO Severin Schwan said on Wednesday's call that it was still a focus, although he declined to share detailed capacity figures. He noted that the vast majority of the sales impact from SARS-CoV-2 came from the molecular tests, with a lower impact from antibody testing. 

Schinecker also emphasized capacity increases, saying the firm had increased to four times its normal capacity and had ordered multiple different production lines, some specifically focused on consumables. The new lines would be ready soon so the firm can continue ramping its capacity, he said.

Schwan said the firm is expecting good growth in the coming quarters as routine testing volumes pick back up and the COVID-19 testing demand continues. "There's a new equilibrium where healthcare systems are again ready for patients who suffer from other severe diseases such as cancer [and] autoimmune diseases," Schwan said.

Schinecker said the decline in non-SARS-CoV-2 diagnostics was concerning because "cancer doesn't stop just because of COVID-19," and noted that many people were not being diagnosed with cancer because hospitals were focused on SARS-CoV-2. Blood screening and cervical cancer screening saw significant decline as well, which Shinecker said could lead to potential negative impacts in the future.

Beyond SARS-CoV-2, Roche has multiple other assays in the pipeline, including three to detect antibodies to Epstein-Barr virus and one to detect and confirm HIV-1 and HIV-2.