360Dx Top 30 Ticks up 2 Percent in August

Note: This story originally named Castle Biosciences as the company with the highest share price gain and has been edited to reflect CareDx as the highest gainer. 

NEW YORK – The 360Dx Top 30 ticked up another 2 percent in August following an 11 percent leap in July.

The Top 30 matched or bettered the broader market as the Dow Jones Industrial Average also rose 2 percent and both the Nasdaq and the Nasdaq Biotech Index increased 1 percent month over month.

The Top 30's largest gainers were CareDx (+54 percent), Exact Sciences (+35 percent), and Veracyte (+31 percent). The main decliners were DermTech (-67 percent), Guardant Health (-27 percent), and Sophia Genetics (-13 percent).

CareDx saw its share price rise after the US Centers for Medicare and Medicaid Services said that its Medicare administrative contractors have refrained from finalizing a proposed local coverage determination that would change coverage of noninvasive blood-based surveillance testing for solid organ allograft rejection, such as CareDx's AlloSure, AlloMap, and HeartCare tests. The proposed LCD and a related billing and coding article raised concerns about limiting patient access to transplant tests and previously caused CareDx to withdraw its full-year 2023 financial guidance.

Exact Sciences' key news last month was the announcement that it has enrolled the first patient into its multi-cancer early detection (MCED) Falcon Registry Real-World Evidence study. The study aims to recruit up to 25,000 people to assess the clinical performance, patient and provider experience, and psychological impact of MCED testing over a five-year span. The US Food and Drug Administration granted an investigational device exemption to the company's laboratory-developed MCED test to allow its use in the study.

Veracyte's stock price was boosted in August by its Q2 financial results. The firm reported Q2 revenues of $114.4 million, up 27 percent from $90.3 million in Q2 2023 and beating analysts' average estimate. As a result, the company raised its full-year financial guidance to between $432 million and $438 million from $402 million to $410 million.

In addition to its financial results, Veracyte also benefited from final local coverage determinations from Medicare's MolDx program. Medicare administrative contractor Palmetto GBA agreed to cover gene expression profile tests for prostate cancer and molecular assays to help diagnose or rule out lung cancer in certain circumstances and cited Veracyte's Decipher Prostate and Percepta Genomic Sequencing Classifier, respectively, as potentially covered tests. Other MACs in the MolDx program aligned their coverage with Palmetto's.

Among the decliners, DermTech continued to be impacted by its bankruptcy. The company's shares were delisted from the Nasdaq in June and moved to the over-the-counter market. Last week, the firm said it sold substantially all its assets to Derm-Jes Holdings, resumed operations under its current name, and became a private company. It will retain its laboratory in San Diego and continue processing orders for the DermTech Melanoma test.

Guardant made multiple key announcements last month that may have impacted its share price. Toward the beginning of August, the firm reported that its Q2 2024 revenues rose 29 percent year over year to $177.2 million from $137.2 million in the prior-year quarter, beating analysts' average estimate of $161.9 million. The firm raised its full-year 2024 financial guidance to be in the range of $690 million to $700 million, up from the previous guidance of $675 million to $685 million.

At the end of the month, Guardant Health Japan said that the country's Ministry of Health, Labour, and Welfare approved Guardant360 CDx as a companion diagnostic for Janssen Pharmaceutical's amivantamab-vmjw.

Like Guardant, Sophia Genetics also reported financial results that may have had an effect on the firm's share price last month. The company's second quarter revenues rose 5 percent to $15.8 million from $15.1 million in Q2 2023 but missed analysts' average estimate of $17.4 million. Results fell below company expectations due to challenges related to the firm's BioPharma business and its efforts to penetrate the European market, CEO and Cofounder Jurgi Camblong said upon the announcement of the results.

Later in the month, the company said that it received CE marking under the European Union's In Vitro Diagnostic Regulation for its Data-Driven Medicine platform, a cloud-based deep learning software-as-a-service platform used to analyze genomic and clinical data to inform drug discovery and development and treatment decisions.

*Bio-Techne paid a dividend of $.08 per share on Aug. 19.

**Labcorp paid a dividend of $.72 per share on Aug. 29.