Theranos is looking for a new lab director in Palo Alto, California after the qualifications of the physician currently running the laboratory came into question by other specialists. The physician in question, medical doctor Sunil Dhawan (Theranos), has been supervising the lab associated with his dermatology practice for 21 years and is board certified for both internal medicine and dermatology.
- Theranos is looking for a new lab director after the qualifications of the current one have been called into question by specialists.
- Theranos has developed a new blood diagnostic start-up that can test for multiple diseases with only the prick of a finger
- The company has faced some issues of quality and the technology it has to perform the tests has been questioned recently.
Though many might say that both his experience in supervising a lab and his medical degree make him eligible for the job, some specialists claim that he may not have the required experience to run a full reference lab like the one Theranos has hired him to supervise, mainly due to the fact that he is not board certified in pathology or laboratory science.
Theranos is a blood diagnostic startup that was founded by entrepreneur Elizabeth Holmes when she was 19. It garnered some interest when it claimed the ability to revolutionize health care by using a new simple way to run blood tests, in which one prick of the finger would be sufficient to test for multiple diseases.
Earlier this year Theranos CEO Elizabeth Holmes had an announcement to make: the Food and Drug Administration had given a 510k approval to the company’s testing system for herpes. Although Holmes and the company celebrated the news and considered it an acknowledgement of the technology’s performance and accuracy, it seems that FDA representatives themselves feel differently.
According to a report commissioned by the FDA itself, the 510k clearance doesn’t necessarily mean that the service in question has been deemed as safe or effective. What it could mean in this case is that Theranos’ tests are similar to other products on the market that have already been approved by the FDA.
Thanks to Holmes’ implication Theranos obtained great reactions at first, including a $9 billion evaluation, great media coverage and an impressive board of directors. But since the launch of the new testing method new problems have appeared and are now causing experts to wonder how well the technology Theranos has actually works.
Theranos has received several forms from the FDA citing a number of issues such as the lack of a proper client complaint system or the sale of unapproved devices across state lines. In a report published by the Wall Street Journal it has also been found that by the end of 2014 the company hardly ever used its famous finger-prick tests.
Holmes has claimed that this is because of the FDA transition and because they are trying to address the complaint forms in order to gain the approval needed to continue. But, while not uncommon in the medical device field, these issues need to be addressed. It seems that Theranos needs experienced professionals to guide them through the FDA approval process before more mistakes are made.
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