Medical devicefor diagnosing appendicitis.
AspenBio Pharma a leading biotechnology company has come up with its patented devise which they claim that is usefull in diagnosing appendicitis .
The AspenBio Pharma’s test is a patented assay method which is capable of detects a marker and protein compounds in the blood of patient with a appendicitis the marker antigens and protein compounds are produced by process of inflammation in appendicitis, after the FDA approval for the device, it will the first of its kind diagnostic tool available in the world for appendicitis and it is said that the device will be useful in diagnosing , evaluating, safe, economical and faster diagnostic test appendicitis.
The AspenBio Pharma is in the process of finalizing the out come results of their clinical trial for this device and for submission of 510(k) ( What is 510(k) clearance )
Brand name for this devise is AppyScore and is estimated to fetch about $1 billion globally every year.
This tequnique (AppyScore ) will be cheaper compared to the regular techniques used like CT scans and are less time consuming than CT scans.
AppyScore consists of , a cassette and reader instrument which can give results with more accuracy and rapidly than the ELISA format. AppyScore is said to have many advantages over an ELISA-based test. It can provide results in 15 minutes, it has a built-in electronic interface which can be used to load the test results in the hospital’s computerized Laboratory System.
What is appendicitis
There is a cecum a structure of colon which looks like a pouch. And there tube like blind ended structure avg. 10 cm in length this structure is called appendix its location is near the junction of the small intestine and the large intestine.
Appendix is belived to have immune function as it consist of lymphoid cells , they fight incoming infection in GIT, it also helps in maintaining the beneficial intestinal bacterial floora .
The inflammatory condition of Appendix is known as appendicitis , it result in severe acute abdominal pain , and if left untreated may become life threatening due to peritonitis and shock.
The treatment so for appendicitis is surgical removal of inflamed Appendix ,and early diagnosis is important part in treatment of appendicitis.
Appendicitis becomes critical in case when it ruptures and spreads infection over gastrointestinal organs and body parts , in such cases recovery is slow and may prove fatal , hence many times in emergences preferred treatment for appendicitis is appendectomy, on time diagnosis is also equaly important for appendectomy surgery
Here are some articles which will be useful for you in further understanding of aspects of sterile dosage form manufacturing and regulatory affairs and good manufacturing practice in pharmaceutical industry
Types of validations in pharmaceutical manufacturing
Requirements of documents for validation of sterilisation process
How to investigate OOS out of specification results
Determination of Phenol coeeficient of a disinfectant
Time limitations in sterile pharmaceuticals processing
Aspects of validation of manufacturing process in sterile pharmaceuticals
Controling Pyrogens in injectable dosage forms
Media fill run process simulation aspects Validation of Aseptic Process and Sterilisation
New Drug Application (NDA) how to make a New Drug Application (NDA) to US FDA
Abbreviated New Drug Application (ANDA) What is ANDA , detaied information about ANDA preparation and submission to US FDA
How to make Investigational New Drug (IND) Application to US FDA
Drug applications submission to us fda Over the counter Drugs OTC drugs
BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
Eletronic record in pharmaceutical manufacturing industry
Good manufacturing practice in pharmaceutical industry
Pharmaceutical industry pharmaceutical companies and FDA latest updates