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Date: 2017-12-12

Type of information: Product launch

Product name: NextCollect™ Urine Collection and DNA Preservation Kit

Compound:

Therapeutic area: Technology - Services

Action mechanism:

  • NextCollect™ is a proprietary high volume urine specimen collection and stabilization kit. Formulated DNA preservative solution is integrated into the NextCollect™ reservoir cap, and dispensed when the cap is secured to the NextCollect™ cup. When added to the urine specimen, NextCollect™ preserves DNA during transport for up to 2 weeks at room temperature. NextCollect™ is designed to collect a higher volume of urine specimen, containing more DNA available for testing methods. NextCollect™ urine extracted DNA can be used for a range of applications across oncology, urology, virology and infectious disease. NextCollect™ is intended for Research Use Only (RUO) and not for use in diagnostic procedures.

Company: Trovagene (USA - CA)

Disease:

Latest news:

  • • On December 12, 2017, Trovagene announced that its proprietary NextCollect™ urine collection and DNA preservation kit is now available, for research use only, to clinical research laboratories and pharmaceutical customers. NextCollect™ is being offered to both existing contracted clients and to new customers through an online ordering web distribution portal. NextCollect™ enables high-volume, non-invasive urine sample collection and isolation of DNA, and has the potential to expand the utility of nucleic acid testing from urine, including oncology, virology and infectious disease.
  • NextCollect™ accommodates up to 250 mL of volume in its urine collection cup with a built-in delivery of a preservative fluid in the collection cup lid to maximize the amount of cfDNA collected in each urine sample, while minimizing total DNA degradation during transport and storage. NextCollect™ is designed for high-throughput lab processing with the ability to fit directly into standard centrifuge systems for initial specimen DNA separation requirements.
  • Trovagene plans to make its DNA Isolation Buffer Kits available in early 2018 to complement the NextCollect™ collection applications. These kits support the isolation of pre- and post-renal cell free DNA and RNA, utilizing the methods developed with the Trovera® ctDNA tests and can enable research laboratories to extract significantly more DNA than currently available methods.
   

Patents:

Submission of marketing authorization application USA :

Submission of marketing authorization application UE:

Withdrawal of marketing authorization application USA:

Withdrawal of marketing authorization application UE:

US authorization:

UE authorization:

Favourable opinion UE:

Favourable opinion USA:

Orphan status USA:

Orphan status UE:

Pediatric exclusivit _USA:

Pediatric exclusivity UE:

OTC status:

Other news:

Is general: Yes