Adaptive Biotechnologies Corp. posted revenue of $30.2 million for the fourth quarter of 2020, up 25% from the corresponding prior year period. The tally beat consensus by $3.3 million. Clinical sequencing volume grew 41% to 4,539 clinical tests, compared with the fourth quarter of 2019.

For the full year, revenue increased 16% year over year to $98.4 million, and clinical sequencing volume topped out at 15,216 clinical tests delivered, up 50%.

The results coincided with the launch of the company’s T-Detect COVID, the first clinical T cell-based test to confirm recent or prior COVID-19 infection. The in vitro diagnostic is available by prescription only for use as a CLIA-validated laboratory-developed test (LDT) by patients ages 18 and older.

In real-world studies, T-Detect COVID outperformed leading antibody tests. In results published in November, T-Detect identified 97% of past polymerase chain reaction (PCR)-confirmed SARS-CoV-2 infections, compared with 77% with U.S. FDA emergency use authorized antibody testing at similar specificity approximately two months after PCR diagnosis. The T-cell response was greater in symptomatic vs. asymptomatic subjects, whereas there was no correlation between antibody levels and disease severity in recovered patients.

The test is currently being reviewed by the U.S. FDA for emergency use authorization. Patients can order T-Detect COVID online by answering some eligibility questions via secure portal and obtain a prescription from a virtual provider. They can then have their blood drawn at home by a mobile phlebotomist or visit one of nearly 2,000 patient service centers via a partnership with Laboratory Corporation of America. Patients can see their results via the secure portal.

More T-Detect tests in the works

The COVID-19 test is the first of a string of T cell-based tests that Adaptive plans to develop. Other targets include Lyme, Crohn’s and Celiac disease.

“Adaptive’s launch of T-Detect COVID marks a pivotal moment in the diagnostic testing paradigm. We have now proven that it is possible to read how T cells detect disease in the blood, and we are on a fast path to develop this product for many other indications,” said CEO and co-founder Chad Robins. “As we move into 2021, we are poised to execute on several key catalysts across all business areas that will accelerate our vision to power the age of immune medicine.”

During a Wednesday earnings call, Julie Rubinstein, Adaptive’s president, said the company expects to launch T-Detect Lyme in its CLIA lab in the fourth quarter of 2021. Enrollment in a trial to support regulatory clearance is ongoing.

“We are also actively progressing in Crohn’s disease with several thousand Crohn’s case-control samples expected to read out throughout the year,” she said. “We also expect the readout of our 1,000 patient Celiac study later this year. … GI [gastrointestinal] conditions may be a good cluster of diseases for which we can develop a panel to offer differentiated diagnosis of patients with shared system.”

Longer term, the goal is to enable “population immunomics, whereby T-Detect can become one test with many results, all driven by the same blood sample that informs the general health of a person or a population,” Rubinstein said.

Also in clinical diagnostics, Adaptive secured its first label expansion for Clonoseq in chronic lymphocytic leukemia in both blood and bone marrow. The company recently filed with the FDA for an added indication in acute lymphocytic leukemia in blood.

Life sciences, drug discovery

Turning to its life science research business, Adaptive touted the launch of Immunoseq T-Map COVID to illuminate T-cell responses for vaccine developers and growing adoption of its updated Immunoseq research-use-only kit, including 35 new Core Labs partnerships and contracts with two global contract research organizations in 2020.

The company is currently working with several vaccine developers, including Astrazeneca plc (AZ) and Oxford University, in conjunction with the Bill & Melinda Gates Foundation, to evaluate the T-cell response to various COVID-19 vaccines in their studies.

In January, Adaptive announced a multiyear pan portfolio partnership with AZ to map T-cell receptors to cancer antigen and AZ’s cancer medicines portfolio. “Immunoseq T-Map doesn’t just apply to COVID. It applies to any disease,” Rubinstein said.

The company also reported progress in its drug discovery pipeline, including a T-cell receptor discovery collaboration with Genentech Inc. The South San Francisco-based drugmaker intends to file an IND for the first shared product in the second quarter of this year.

Cowen maintained its “outperform” rating for the company. “Pipeline progress remains palpable and, generally speaking, ADPT continues to progress well,” Cowen’s Doug Schenkel wrote. “COVID-19 initiatives have led to notable and unique Dx and research product/services.”

Adaptive provided full-year guidance for 2021 in the $145 million to $155 million range – representing 52% growth at the midpoint range. Sequencing revenue is expected to generate 50% to 55% of total revenue for the year.