NEW YORK – Rebounding from a 6 percent tumble in April, the 360Dx Top 30 rose nearly 3 percent in May.
The Top 30 reflected broader market trends as the Dow Jones Industrial Average rose 2 percent and the Nasdaq grew 7 percent last month, while the Nasdaq Biotech Index increased 6 percent month over month.
The Top 30's largest gainers were CareDx (+68 percent), Guardant Health (+51 percent), and Adaptive Biotechnologies (+32 percent). The decliners were led by DermTech (-52 percent), Exact Sciences (-23 percent), and Sera Prognostics (-23 percent).
CareDx's share price was boosted last month by the announcement of its Q1 financial results, as it reported that despite revenues declining 7 percent to $72.0 million, the firm beat the consensus analyst estimate. The company also raised its full-year 2024 guidance due to the better-than-anticipated results.
The firm also last month benefited from new study results that showed its HeartCare product, which combines the AlloSure Heart donor-derived cell-free DNA (dd-cfDNA) and AlloMap Heart gene-expression profiling, was able to identify acute cellular rejection better than dd-cfDNA testing alone and resulted in fewer biopsies among transplant patients.
The study's results could drive increased adoption and payor coverage of the test, analysts said.
At the end of the month, however, CareDx stock dipped on news that Natera requested a permanent injunction against the company in an ongoing patent lawsuit related to the AlloSure test. The suit relates to patents covering methods of cleaning noisy genetic data and determining chromosome copy number.
Like CareDx, Guardant Health saw a boost from the announcement of its Q1 financial results last month. The firm reported that revenues increased 31 percent to $168.5 million from $128.7 million year over year and raised its full-year guidance to reflect the results.
Also in May, Guardant's liquid biopsy comprehensive genomic profiling and companion diagnostic test, Guardant360 CDx, received certification under the European Union's In Vitro Diagnostic Regulation.
At the end of last month, Guardant received an additional boost from the long-awaited findings of a US Food and Drug Administration advisory committee. The FDA-commissioned panel evaluated the Guardant Shield colon cancer screening test, and a majority of the panel members voted to recognize the assay as safe, likely effective, and having benefits that outweigh its risk when used in its designated indication.
Continuing the trend, fellow gainer Adaptive Biotechnologies saw its share price rise after reporting its Q1 financial results. The company's revenues for the quarter were $41.9 million, up 11 percent from $37.6 million and slightly less than the anticipated 12 percent increase. The revenues beat the average Wall Street estimate.
Among the decliners, DermTech's only key news last month was the announcement that its first quarter revenues grew 9 percent to $3.8 million from $3.5 million in Q1 2023. Test revenues rose to $3.7 million from $3.4 million, while contract revenues were $168,000 compared to $52,000 in the first quarter of 2023.
Along with the other gainers and decliners, Exact Sciences announced its Q1 financial results last month. The firm saw revenues of $637.5 million, up 6 percent from $602.5 million in Q1 2023 and exceeding analysts' average estimate of $627.4 million.
Also in May, the UK's National Institute for Health and Care Excellence recommended Exact Sciences' Oncotype DX prognostic gene expression test — along with two other assays — as a tool for guiding adjuvant chemotherapy treatment decisions in an expanded population of early breast cancer patients.
Toward the end of the month, the US District Court for the District of Delaware denied Geneoscopy's motion to dismiss a patent infringement lawsuit filed against it by Exact Sciences. The lawsuit, which was filed last year, alleges that Geneoscopy's test infringes on the patent central to Exact's Cologuard assay.
Earlier in May, Geneoscopy received FDA approval for its noninvasive stool-based colorectal cancer test that would directly compete with Cologuard.
Sera Prognostics also announced in May that it had no first quarter revenues. The firm's Q1 revenue before adjustments was $39,000, down 61 percent from $100,000 in Q1 2023, but after a review of accounting estimates for older tests it determined that it had no Q1 2024 revenue.
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360Dx Top 30
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*Bio-Techne paid a dividend of $.08 per share on May 10.
**Labcorp paid a dividend of $.72 per share on May 24.