Sequenom Sells Bioscience Unit to Agena

Sequenom (San Diego, CA, USA) has sold its Bioscience business for up-to-USD 35.8 million to Agena Bioscience (San Diego, CA, USA), which said it plans to expand clinical use of the Massarray System for mass spectrometry-based detection of nucleic acids.

Agena agreed to pay Sequenom USD 31.8 million cash up front, plus up to USD 4 million in contingent consideration tied to achieving undisclosed regulatory and sales milestones. Agena assumed the lease for the Bioscience business in San Diego, as well as liabilities related to Bioscience—but which does not include any portion of Sequenom¹s bank debt or convertible notes outstanding, the buyer said.

Achieving that expansion will be the job of Agena’s new chairman and interim CEO John Lillig, a senior life sciences and diagnostics industry executive with more than 30 years of experience in clinical diagnostics, as well as the life science instruments and reagents markets.

“Massarray has become a fundamental tool for genomic research. We believe it will have a similar impact as a high throughput and cost effective workhorse technology for mutation detection and targeted genomic analysis of cancer and other diseases in the clinical laboratory setting as well,” Lillig said in a statement.

Agena said it will improve the Massarray System with expanded hardware automation, software functionality, high value assay content, and resources to support growing use in basic, agricultural, and clinical research. Massarray has been used in more than 2,000 published research studies, Agena said. It incorporates MALDI-TOF mass spectrometry for highly sensitive and specific interrogation of tens to hundreds of multiplexed genetic biomarkers.

The company also intends to extend the Massarray platform into the in vitro diagnostic market with the impact Dx System, for which it has filed a Premarket 510(k) Notification with the US Food and Drug Administration (FDA; Silver Spring, MD, USA)

Agena said it has retained all of the former Sequenom Bioscience employees, and will keep the business headquartered in San Diego. The sale comes almost a year after Sequenom said it would conduct a strategic review of its Bioscience unit, once known as Genetic Analysis. Harry F. Hixson, Jr., Sequenom’s chairman and CEO stated, “This sale strengthens our balance sheet, and will enable us to focus exclusively on our Sequenom Laboratories business as we work toward achieving profitability.”

In a separate but related announcement, Agena said it will make available later this year to clinical researchers an online tool for Massarray that will enable the designing of custom Ultraseek panels for ultrasensitive interrogation of low-level mutations. Ultraseek is the first ultrasensitive somatic mutation detection technology for high-throughput and definitive interrogation of rare mutations that occur at less than 1% abundance in matched tissue circulating plasma and tumor samples.

The first panel made available this year, the Ultraseek Oncogene Panel, uses 40 ng of input DNA to interrogate 26 driver mutations in 12 critical oncogenes.

Ultraseek is intended to enhance the sensitivity of the single-allele base extension reaction (Saber) method for Massarray genotyping. Saber was employed by Kazuto Nishio, MD, PhD, and colleagues at Kinki University and several Japanese medical centers to profile lung cancer-related gene fusions and rare somatic hotspot mutations that may affect patients' therapeutic responses in a phase III trial of multiple lung cancer drugs. Data from the study was presented Saturday at the American Society for Clinical Oncology (ASCO) annual meeting in Chicago, which took place from May 30–June 3, 2014.

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Sequenom
Agena Bioscience
US Food and Drug Administration