(Boursier.com) — Biosynex announces that the company ProciseDx based in San Diego, in which it holds 42.7% of the capital alongside Nestlé Health Science which owns 43.13%, has just obtained 510(k) authorization from the FDA (US Food and Drug Administration) for the commercialization of the ProciseDx instrument and the ProciseDx CRP test.
This first authorization devotes years of development of the ProciseDx platform based on an innovative TR FRET technology allowing the performance of quantitative tests at the point of care in 2 to 5 minutes. It constitutes a major step in the validation of the ProciseDx technology.
ProciseDx has obtained CE marking for 4 products in the field of gastroenterology. Around thirty instruments are currently installed in Europe and the Middle East for routine use in patients with inflammatory bowel disease (IBD) such as Crohn’s disease or ulcerative colitis. About fifty other sites are being equipped.
On the American market, ProciseDx has also submitted de novo 510(k) authorization applications to the FDA for biotherapy monitoring tests: Dosage of Infliximab (Remicade and biosimilars) and Adalimumab (Humira and biosimilars).
“The dosage of these drugs is currently carried out on centralized biology automatons and the result obtained in several hours is transmitted to the doctor and the patient several days after the sample is taken. The ProciseDx platform will make it possible to obtain a quantitative result in 5 minutes or less and can be used in gastroenterology offices or small to medium-sized clinics,” said Larry Mimms, President and Chief Scientific Officer of ProciseDx.
This first FDA authorization comes a few weeks after the signature of a license agreement between Biosynex and ProciseDx allowing Biosynex to manufacture on its site the products already developed by ProciseDx and to develop new applications on this platform. For its part, ProciseDx retains the marketing rights in the US, Canada, China and Japan.
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