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In Brief This Week: CAP, T2 Biosystems, Siemens Healthineers, DiaSorin, More

NEW YORK –  The College of American Pathologists and the American Society of Clinical Oncology said this week that they have reaffirmed the Human Epidermal Growth Factor Receptor 2 (HER2) Breast Cancer Testing Guidelines following a review of the recent DESTINY-Breast04 clinical trial for metastatic breast cancer patients that found a treatment traditionally used in HER2-positive patients was also effective in patients considered HER2-negative. CAP and ASCO did not recommend changes in HER2 reporting terminology, but the updated guidelines emphasize awareness of the new clinical significance of specific HER2 protein levels reported and include a reporting comment footnote to clarify that significance. 

T2 Biosystems announced this week that it has submitted an application for Breakthrough Device Designation to the US Food and Drug Administration for its direct-from-blood Candida auris Panel. The panel runs on the firm's T2Dx instrument and simultaneously detects five Candida species. Breakthrough Device Designation could potentially accelerate the path to FDA clearance and commercialization, the firm said in a statement. T2 also recently announced plans to add C. auris detection for its FDA-cleared T2Candida Panel. 

Abbott this week said it has declared a quarterly dividend of $.51 per share, payable on Aug. 15 to shareholders of record at the close of business on July 14.

Siemens Healthineers and drone maker Wingcopter said last week that they’ve signed an agreement that will provide Siemens' laboratory testing services in areas of Africa with limited access to healthcare. Under a memorandum of understanding, Wingcopter's highly automated drone-based service will allow for quick delivery of patient samples, medicine, and other medical products and maintain cold chains for those products. The delivery network will also allow increased centralization of sample testing and medical consumable distribution, which will improve testing access, turnaround times, and efficiency, the firms said. The locations for the drone-based laboratory sample deliveries have not been announced. 

The Italian National Commission for Companies and the Stock Exchange (CONSOB) fined DiaSorin €100,000 and company CEO Carlo Rosa €20,000 this week on allegations the company violated requirements related to disclosure of inside information as well as disqualified Rosa from holding a leadership position in a listed company for two months on allegations of illegal communication of inside information. DiaSorin and Rosa have filed appeals. 

The fine against the company relates to information disclosed through press releases in March and April of 2020 regarding the completion of studies that the company planned to use in support of CE marking and US Food and Drug Administration Emergency Use Authorization of a molecular test and an immunoassay for SARS-CoV-2. The company said that, according to CONSOB, those press releases disclosed inside information about upcoming products that could have substantial benefits to the company and that Rosa was accused of having a private conversation about the same information. 

In a statement, DiaSorin officials said the firm believes the press releases were consistent with past practices and its behavior was in line with that of other diagnostic companies in Europe. The firm noted that Rosa has not been charged with illegal transactions related to shares of DiaSorin or any other unlawful activities involving company securities. 

DermTech said this week that it has signed an agreement with a Blues plan payor in Hawaii, enhancing access to its melanoma test for this plan's nearly 800,000 members. The move brings DermTech's total covered lives in the US to approximately 126 million, including 68 million under Medicare and another 58 million served by commercial and governmental payors. 

The DermTech Melanoma Test is designed to assess pigmented lesions, using RT-PCR to detect expression of the LINC and PRAME genes and, optionally, DNA sequencing to identify mutations in the TERT promoter region. Positive results for any of those biomarkers are correlated with a higher risk of melanoma. If none are detected, it indicates a greater than 99 percent probability that the mole being tested is not a melanoma. 

Renalytix said this week that its fiscal third quarter revenues declined about 11 percent year-over-year, but it also made progress toward regulatory clearance and payer coverage of its kidney disease progression test.

The London-based firm reported revenues of $724,000 for the three months ended March 31, down from $812,000 in Q3 2022. The consensus Wall Street estimate was for $1.3 million in revenues for the recently completed quarter. The firm said it has made continued progress toward US Food and Drug Administration de novo authorization of its KidneyIntelX blood-based assay for acute and chronic kidney disease detection and risk scoring and the firm expects a decision on authorization by the end of June.

The firm posted a net loss of $12.1 million for the quarter, or $.14 per share, compared to a loss of $14.7 million, or $.20 per share, in the year-ago quarter. The consensus Wall Street estimate was a loss per share of $.11.

The firm had $33 million in cash and cash equivalents as of March 31.

Prenetics this week reported $17.7 million in first quarter revenues, down 81 percent from $92.0 million in the year-ago quarter. The Hong Kong-based genomics and precision medicine company provided no explanation for the revenue shortfall. Its net loss in Q1 widened to $11.6 million, or $.07 per share, from a net loss of $33.5 million, or $1.06 per share, a year ago. The number of weighted average common shares used to calculate net loss was 157.8 million in Q1 2023 compared to 31.2 million in Q1 2022. Prenetics ended the quarter with $166.3 million in cash and cash equivalents and $19.9 million in short-term deposits. 

ChromaCode said this week that it has received a strategic investment of undisclosed size from Shimadzu Future Innovation Fund and its general partner Global Brain to further develop the firm’s High Definition PCR (HDPCR) platform technology for use in oncology. The goal is to deliver high-quality, fast, and inexpensive diagnostic tools for disease detection and monitoring. 

Hememics Biotechnologies said this week that it is collaborating with General Graphene to develop a scalable, non-clean-room process to manufacture Hememics' 32-plex, graphene biosensor chips. Gaithersburg, Maryland-based Hememics' handheld reader can provide test results in no more than 5 minutes. Additionally, it is about 100 times more sensitive than a typical lateral flow test kit while remaining cost competitive on a per test basis, the firm said, adding that Hememics and General Graphene have manufactured more than 100,000 graphene biosensors in the past nine months. The chips can detect multiple pathogens from a single saliva or blood sample. 

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared on 360Dx.