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In Brief This Week:, Hologic, Revvity, Pillar Biosciences, Mainz Biomed, More

NEW YORK — Hologic has reported to the Connecticut Department of Labor that the company will lay off 86 employees and close a Connecticut manufacturing facility as the firm consolidates production facilities for its breast health products at a facility in Delaware. The Marlborough, Massachusetts-based firm said in a recent filing with the state that it is laying off 71 employees effective Dec. 20 as well as 15 other employees who will perform post-closure work until they are let go in January and February of 2025. Hologic said by email that many other employees of the Danbury plant have elected to continue working for Hologic by transferring to a facility in Newark, Delaware. 

The Connecticut plant has been used to manufacture mammography systems and other products for Hologic's breast health business. 


Pillar Biosciences this week said that the American Medical Association has granted proprietary laboratory analyses code 0523U to the firm's OncoReveal CDx pan-cancer in vitro diagnostic NGS kit. The kit, which was approved by the US Food and Drug Administration in April, leverages Pillar's Stem-Loop Inhibition-Mediated amplification (SLIMamp) technology to detect single nucleotide variants, insertions, and deletions in 22 genes using DNA isolated from formalin-fixed, paraffin-embedded tumor tissue specimens. OncoReveal CDx was cleared for use on the Illumina MiSeq Dx instrument and approved as a companion diagnostic test to identify patients who may benefit from EGFR TKI therapy in NSCLC, and from Eli Lilly's Erbitux (cetuximab) or Amgen's Vectibix (panitumumab) for KRAS in colorectal cancer, Pillar noted. 


Revvity said this week that its board of directors has authorized a quarterly dividend of $.07 per common share, payable on Feb. 7, 2025, to shareholders of record as of Jan. 17, 2025. 


BioAffinity Technologies said this week that it has raised about $2.7 million through a registered direct offering for the purchase and sale of 2,048,294 shares of common stock at $1.30 per share and the concurrent private placement of warrants to purchase up to 2,662,782 shares of common stock. The warrants will have an exercise price of $1.50 per share, and they will be initially exercisable on the date that shareholders approve of the exercise of warrants and will expire five years from that date of approval. The firm plans to use the proceeds for general corporate purposes including to secure working capital. WallachBeth Capital was the placement agent for the offering. 


Colorectal cancer screening firm Mainz Biomed this week released its financial results for the first half of 2024, reporting that the firm's revenues increased 4 percent to $520,773 from $499,049 in the first half of 2023. The firm's net loss was $11.1 million, or $.49 per share, compared to $15.0 million, or $1.00 per share, in the prior-year period. The company ended the period with $977,764 in cash. The firm noted that this month it restructured its operations and implemented cost reductions by decreasing operating costs, primarily through reduction of personnel and external consulting costs. It also decided to focus on three key initiatives for the rest of 2024 and into 2025, namely continuing to grow its ColoAlert business in Europe, developing its next-generation colorectal cancer screening test, and running a 2,000-patient study to prepare for a new submission to the US Food and Drug Administration for breakthrough device designation. 


Proteomics testing firm Proteomics International Laboratories (PIL) this week reported financial results for Q3 2024. For the three months ending Sept. 30, the company reported revenue of $A253,000 (US$167,890), up 26 percent from $A201,000 in Q3 2023. It reported a net loss for the quarter of $A1.5 million compared to a net loss of $A1.7 million in the year-ago period. R&D spending in Q3 2024 was $A1.0 million, up 46 percent from $A685,000 in Q2 2023. PIL ended the quarter with $A5.1 million in cash and cash equivalents. The company noted that it is aiming for a commercial launch of its PromarkerD test for diabetic kidney disease in the US and Australia in the first half of 2025. 


Dante Omics said this week that its laboratory in Italy has obtained ISO 9001:2015 certification for providing genomic next-generation sequencing, analysis, and interpretation services. The firm said it plans to further expand its research capabilities and enhance its AI-driven genomics products. 


Fujita Health University of Japan and BostonGene said this week that the Fujita Health University Haneda Clinic will start offering genomic profiling tests for cancer patients using the BostonGene Tumor Portrait test. The test integrates DNA and RNA sequencing and detects actionable mutations, properties of the tumor microenvironment, and treatment response biomarkers. 


Helio Genomics this week announced a partnership with Halub Medical to commercialize in Saudi Arabia the HelioLiver Dx test for the early detection of hepatocellular carcinoma. HelioLiver Dx is a multianalyte blood test that assesses cfDNA, methylation patterns, serum protein biomarkers, and demographic information. The test is expected to be available in Saudi Arabia and the Gulf Cooperation Council in Q1 2025, with the following 12-month revenue expected to be more than $12 million, Helio Genomics said. The Irvine, California-based firm leverages artificial intelligence to develop diagnostics for the early detection of cancer. Taif, Saudi Arabia-based Halub Medical specializes in distributing laboratory diagnostic test kits in the GCC and the Middle East. Financial and other terms of the deal were not disclosed.


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.