Skip to main content
Premium Trial:

Request an Annual Quote

Roche Expands Non-COVID-19 Tests as Base Business Recovers From Pandemic


NEW YORK – Roche Diagnostics' business has continued its growth during the first half of 2021, partially on the back of demand for its 21 COVID-19 products.

However, it hasn't ignored its base business, which has seen a "really strong recovery" this year, Roche CEO Severin Schwan said on a conference call to discuss the firm's first-half financial results Thursday. A number of recent launches and test expansions have come up on the non-COVID-19 side of the diagnostics segment, including cardiovascular, oncology, and Alzheimer's tests.

The company has received intended use extensions for its CE-marked Elecsys NT-proBNP immunoassay and Troponin T-high sensitivity tests to help prevent disease in cardiovascular patients. The troponin T test received 510(k) clearance from the US Food and Drug Administration in 2017 to diagnose myocardial infarction.

The tests' new claims, however, are for use as screening tests. Roche Diagnostics CEO Thomas Schinecker said on the call that the troponin T test will be able to address a larger population as it can be used on preoperative patients who are getting other surgeries to assess whether they will have a cardiac event during or after surgery. That market amounts to about 200 million patients yearly.

In addition, the test can be used for screening asymptomatic at-risk populations, addressing approximately 400 million people per year. It can also act as a rule-out test for high cardiovascular risk in patients with acute coronary syndromes.

Roche's NT-proBNP test is currently used to diagnose acute heart failure in 64 million people each year. The new claims for the test encompass screening for diabetics and elderly people, determining patients with type 2 diabetes who are at risk for cardiovascular disease, a market of 463 million, and elderly patients at risk of atrial fibrillation, a market of 457 million.

The changes in these claims allow the tests to "go from focusing on diagnostics and diagnosis to [a] much earlier setting in screening," Schinecker said, which fits with Roche's overall diagnostics strategy to "enable better patient care and outcomes" by diagnosing "much earlier, when people are still healthy … rather than when basically the situation has already deteriorated."

Another key test for Roche is its Elecsys Anti-p53 assay, which received CE marking in April. The electrochemiluminescence immunoassay quantitatively detects anti-p53 autoantibodies and can be used with other tumor markers and diagnostic tests to detect throat cancer, bowel cancer, and breast cancer. Between 20 percent and 50 percent of patients with mutated p53 will produce the antibodies. The test runs on Roche's Cobas E instruments, which have an installed base of more than 44,000 systems.

Schinecker said on the call that the screening assay can be used earlier to determine if healthy patients have developed cancer.

The firm's Ventana MMR RxDx Panel received approval from the FDA in April. The panel detects four different proteins involved in mismatch repair mechanisms, Schinecker said. If there is a loss of expression of one of the proteins, the repair mechanism doesn't work and a patient accumulates DNA damage.

Detecting the loss of expression can enable targeted treatment decisions based on the MMR protein status. Endometrial cancer has particularly high rates of MMR deficiency, between 20 percent and 40 percent. According to Roche, its test is the first immunohistochemistry-based MMR companion diagnostic test. The test is approved to select endometrial cancer patients for treatment with GlaxoSmithKline's anti-PD-1 antibody dostarlimab (Jemperli).

The Ventana test was previously approved by the FDA in 2017 to screen colorectal cancer patients for mismatch repair deficiency and Lynch syndrome.

Roche has also partnered with Merck to develop the test as a companion diagnostic for the drug firm's pembrolizumab (Keytruda) in treating mismatch repair deficient solid tumors.

The Swiss company is also in the process of seeking FDA clearance for its Elecsys cerebrospinal fluid immunoassays for Alzheimer's disease, Schinecker said. The firm received breakthrough device designation from the agency for the tests in 2018 and have approval outside of the US. Schinecker said Roche is the "only real global player who has actually an Alzheimer's test" and added that no company in the US has approval yet. Quest Diagnostics' Athena Diagnostics, Luminex, and Fujirebio currently offer CSF Alzheimer's tests as laboratory-developed tests in the US.

Schinecker also said there is only one other company outside the US using cerebrospinal fluid, or CSF, markers for Alzheimer's, although he didn't name the company.

One of Roche's tests measures beta-amyloid peptide concentrations, while the other measures phospho-tau peptide concentrations in the CSF of patients with cognitive impairment who are being evaluated for Alzheimer's or other causes of dementia. Schinecker added that Roche is currently working on tests with blood-based markers for Alzheimer's to replace position emission tomography as a testing method because it's expensive and has a long wait time.

In the molecular laboratory space, Roche plans to launch its Cobas 5800 fully automated low-throughput PCR system and its Avenio Edge system for automated sequencing library preparation and target enrichment this year. It also intends to launch the Avenio FoundationOne kit, a research-use-only decentralized kit of the FoundationOne companion diagnostic test.

Even though the COVID-19 pandemic has brought revenue growth to the company, Schinecker said maintaining the firm's base business has always been a priority. "We always said, 'Let's not take the eye off the ball while everything is really busy. Let's also make sure that our underlying business is performing well,'" he said. "And I do believe we are very well positioned."