360Dx Index Maintains Steady Ascent, Increasing 3 Percent in August

NEW YORK – Following two prior months of steady growth, the 360Dx Index continued its climb in August, rising 3 percent month over month.

In the broader markets, the Dow Jones Industrial Average ticked up 1 percent from July, while both the Nasdaq and the Nasdaq Biotech Index rose 4 percent.

The 360Dx Index's largest gainers last month were Guardant Health (+16 percent), Myriad Genetics (+13 percent), and Opko Health (+12 percent). The decliners were led by Burning Rock Biotech (-18 percent), Accelerate Diagnostics (-16 percent), and CareDx (-13 percent).

NantHealth was removed from the index, while PerkinElmer was added.

The biggest reason for Guardant's growth during August was the announcement of its second quarter earnings results, as the company saw its revenues increase 39 percent year over year, beating the consensus Wall Street estimate. That growth was driven by an increase in clinical testing revenue, as well as the achievement of several companion diagnostic project milestones.

The company said on its earnings call that it plans to launch its colorectal cancer screening test within the first half of 2022 as a laboratory-developed test, with an expectation of gaining clearance from the US Food and Drug Administration in 2023. Guardant has been validating the assay in its ECLIPSE prospective trial, which has recruited 10,000 patients and is looking for an additional 3,000 subjects.

Puneet Souda, an analyst with SVB Leerink, wrote in a note that ECLIPSE is the "largest and most meaningful liquid biopsy trial to read out in the near term." He added that Guardant is a "best-in-class liquid biopsy opportunity in a large [$50 billion] market that is bound to see substantial growth over the next few years."

Guardant also stopped offering COVID-19 testing during the month, making the decision to return its focus to oncology testing due to the nationwide rollout of vaccines and the expanded testing options available.

Myriad Genetics' Q2 revenues more than doubled year over year, beating the consensus Wall Street estimate. The rise was attributed to strong performance from the company's hereditary cancer segment.

Later in August, medical technology firm Noviscend signed an agreement with Myriad to exclusively distribute some of its genetic tests in Canada – namely its EndoPredict breast cancer recurrence test; myRisk and myRisk – Hereditary and Single Gene Panel for hereditary cancer risk; myChoiceCDx test for homologous recombination deficiency status in ovarian cancer patients; GeneSight, a pharmacogenomic test for patients with depression; and Prolaris for determining prostate cancer aggressiveness.

The main news from Opko last month was the announcement that its subsidiary BioReference Laboratories acquired the US Ariosa centralized lab prenatal testing business from Roche. BioReference said the acquisition would complement its specialty health division GenPath's ClariTest Core, which uses the same core technology as Ariosa's Harmony Prenatal Test.

Burning Rock's decline was unexpected, as its most significant announcement was that of a partnership with Impact Therapeutics to develop companion diagnostics to identify best responders to Impact's anti-DNA damage repair therapies.

On Tuesday morning, the last day of the month, the company announced that its second quarter revenues had risen 19 percent year over year. Central lab revenues increased 7 percent, while in-hospital testing revenues were up 47 percent. It also saw a 42 percent increase in pharma research and development services revenue due to a growing pipeline of pharmaceutical projects.

While Accelerate Diagnostics announced a 33 percent year-over-year increase in second quarter revenues last month, it missed analysts' average estimate. The firm has faced headwinds from the COVID-19 pandemic, and CEO Jack Phillips said on a conference call to discuss the results that the US infection surge due to the Delta variant is concerning for the company. Some of the hospitals it has approached as potential customers for its antimicrobial susceptibility and rapid identification products have begun to refocus on COVID-related care, he said.

In August, Accelerate also received CE marking for a new configuration of its Accelerate PhenoTest BC kit that provides antimicrobial susceptibility testing and runs on the Accelerate Pheno system in labs that already have a rapid identification system.

BTIG analyst Mark Massaro said in a note that while he is "optimistic that its newly launched AST-only kit will resonate with a number of microbiology labs," he expects "it will take several quarters before we see material traction from the new launch coupled with challenges related to COVID."

There is no clear reason for CareDx's stock price decline.