Posts Tagged ‘Singulex’

JP Morgan Healthcare Conference: Highlights for Day Three and Day Four

Reporter: Aviva Lev-Ari, PhD, RN


JP Morgan Healthcare Day Three: Foundation Med; Cepheid; BD; Invitae; GenMark; Berry Genomics

Jan 14, 2016

Ed Winnick

Monica Heger 

  • Berry Genomics
  • GenMark Diagnostics
  • Invitae
  • Becton Dickinson
  • Cepheid
  • Foundation Medicine

The company’s liquid biopsy assay, FoundationAct, will genomically profile circulating tumor DNA from patients for whom a tissue biopsy cannot be obtained. Pellini stressed that the assay was designed to help guide oncologists’ treatment decisions. But the company is also developing an assay that could be used to monitor patients’ disease burden and response to treatment.

Pellini added that the company is taking a “new approach to companion diagnostics” in work it is doing to develop a universal companion diagnostic that will be a regulated product used with any targeted agent or immunotherapy.




JP Morgan Healthcare Conference Day Four: Luminex, Exact Sciences, T2 Biosystems, Singulex

Jan 15, 2016

a GenomeWeb staff reporter



Luminex received US Food and Drug Administration clearance for the Aries system and Aries Herpes Simplex Virus (HSV) 1&2 Assay last October. The firm launched the real-time PCR-based sample-to-answer system in the fourth quarter of 2015 and is targeting 100 placements by the end of this year, Shamir said.


Exact Sciences

Exact Sciences reported earlier this week that it had sold 38,000 of its Cologuard tests, below its expected 42,000 tests. Conroy attributed the lower sales to a higher-than-expected dropoff in orders around the holidays.


T2 Biosystems

In his presentation, T2 Biosystems President and CEO John McDonough provided an update on the uptake of the company’s T2Dx magnetic resonance-based rapid diagnostic platform and its first test, T2 Candida, a US Food and Drug Administration-cleared assay for the detection of sepsis-causing Candida infections. He also provided attendees with an update on the company’s assay pipeline.

The assay, which was FDA cleared in September 2014, can directly detect Candida species from a patient blood sample without prior culturing in three to five hours and with better sensitivity.

McDonough said that the company has been targeting the top 450 hospitals in the US with the platform and assay and that adoption “has been going at a very nice rate.”


Singulex’s CEO Guido Baechler said that the company will launch its CE-IVD marked single-molecule counting platform, Singulex Clarity, in Europe this year. The first two systems will be installed in Barcelona and London in May and he expects approval for the machine by September.

Baechler added that the company is also looking to bring the platform through US Food and Drug Administration 510(k) clearance with an assay that rules out acute myocardial infarction in patients.




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