NEW YORK – Multiple diagnostic firms released preliminary earnings results for the fourth quarter and full year of 2021 on Monday, including CareDx, Castle Biosciences, Lucira Health, OpGen, Adaptive Biotechnologies, and Sema4.
CareDx announced its Q4 revenues are expected to be between $78.6 and $79.0 million, up between 34 percent and 35 percent from $58.6 million in the year-ago period. Testing services revenue for Q4 is expected to range from $68.2 million to $68.6 million, rising 36 percent from $50.3 million year over year. During the quarter, the firm said it saw test volumes of more than 41,900 tests, including approximately 700 AlloSure Lung tests. CareDx expects product revenue of $7.7 million, up nearly 31 percent from $5.9 million in Q4 2020. Digital and other revenue is estimated to be up almost 13 percent to $2.7 million from $2.4 million a year ago.
For the full year 2021, CareDx said it expects revenues between $295.7 million and $296.1 million, an increase of 54 percent year over year from $192.2 million. Testing services revenue is expected to range from $258.9 million and $259.3 million, up 58 percent from $163.6 million in 2020. Product revenue is expected to be $26.8 million, a 39 percent increase from $19.3 million a year ago, and digital and other revenue is expected to rise to $10.0 million from $9.3 million in FY2020.
Meantime, Castle Biosciences announced that it delivered 8,242 gene expression profile test reports in the fourth quarter of 2021, compared to 5,157 in Q4 2020. DecisionDx-Melanoma test volumes rose 33 percent to 5,635 from 4,246 during the same quarter in 2020. DecisionDx-SCC tests nearly tripled to 1,265 from 428 in the fourth quarter. Total MyPath Melanoma and DecisionDx DiffDx-Melanoma aggregate reports were 904 during the quarter, up from 73 in the year-ago period, and DecisionDx-UM test volumes grew 7 percent to 438.
Castle Bio said it expects to meet or exceed the top end of its previous full-year 2021 guidance of $89 million to $93 million. Total gene expression profile test reports for the year rose 55 percent year over year to 28,118 from 18,185, the company said. DecisionDx-Melanoma tests were up 25 percent to 20,328 during the year, while DecisionDx-UM tests rose 16 percent to 1,618. The number of DecisionDx-SCC reports delivered rose to 3,510 from 485 in 2020, although it was only offered from Aug. 31 to Dec. 31, 2020. And the number of MyPath Melanoma and DecisionDx DiffDx-Melanoma aggregate reports increased to 2,662 for the full year, compared to 73 in 2020 — the aggregate reports were only offered from Nov. 2 to Dec. 31, 2020.
Lucira Health also reported its preliminary quarterly and full year earnings results, announcing that its Q4 2021 revenues are expected to range from $58 million to $60 million, growth of more than 300 percent compared to the third quarter of 2021. Revenue for the full year is expected to be between $90 million and $92 million. Lucira Health went public in February 2021.
OpGen said in a statement that it expects Q4 revenues to be flat at $1.4 million, with full-year total revenues of approximately $4.3 million, up 2 percent from $4.2 million in 2020.
Also, Adaptive Biotechnologies said that revenues for 2021 are expected to be between $153 million and $154 million versus $98.4 million in 2020. Analysts, on average, are expecting full-year revenues of $153.1 million for the Seattle-based firm.
Sema4 said that its fourth quarter revenues are expected to be between $50 million and $52 million, up from previous guidance of $46.6 million to $49.6 million. Analysts, on average, are expecting fourth quarter revenues of $47.42 million for the Stamford, Connecticut-based genomic and clinical data intelligence platform company. The firm also said that its FY 2021 revenues are expected to exceed its previous guidance of revenues between $201 million and $204 million.