搜索
1

1

News Center
/
/
/
Why is it difficult to have an open platform for the popular molecular POCT?

Why is it difficult to have an open platform for the popular molecular POCT?

  • Time of issue:2023-02-17
  • Views:

(Summary description)Talking about the dilemma that open molecular POCT platforms may face.

Why is it difficult to have an open platform for the popular molecular POCT?

(Summary description)Talking about the dilemma that open molecular POCT platforms may face.

  • Categories:Blogs
  • Author:AIVD
  • Origin:
  • Time of issue:2023-02-17 15:41
  • Views:
Information

People often ask whether we can make your molecular POCT platform open so that we can put our own reagents on it and develop our own assays to register and report.


Most of those who ask such questions are traditional molecular diagnostic reagent companies, which have already accumulated some traditional molecular diagnostic reagents, and some kits have already got the registration certificate.


This idea is quite tempting at first hearing.


After all, it takes four to five years to develop a molecular POCT product from the project to the registration certificate. If you can earn some research and development costs in advance through the open platform, it is undoubtedly very tempting for startups.


Moreover, molecular POCT products are mostly entrepreneurial companies, and the market channel has not been established, so let the traditional molecular diagnostic reagents company has a certain accumulation in this area to register to sell, looks like a few complementary advantages of a win-win situation.


For the traditional molecular diagnostic reagent company, such a reference is also their own demand.


After all, the molecular POCT track is currently popular and is one of the main directions of molecular diagnostic automation. Of course, they want to enter this track as soon as possible and occupy a good position. If the company does it by itself, on the one hand, it may not be able to build up the corresponding R&D team, on the other hand, the R&D cycle can't afford to wait.


In this case, if any company is willing to open their more mature molecular POCT platform, then they can put their own mature molecular diagnostic reagents directly up to register, get a certificate, and their own market channels are ready, that is perfect!


In the field of chemiluminescence, there are indeed doing so.


In the field of molecular POCT, there is really an open platform company - iCubate, but it has not done up. It may be that the iCubate itself has a high cost of consumables, and the whole testing system is actually composed of two instruments, and can not really be considered a fully automated nucleic acid testing machine.


But also from the side to verify, open molecular POCT platform may not be as reliable as imagined.


The ideal is very rich, the reality is very skeletal.


Why open molecular POCT platform is not as reliable as imagined?


The following talks about the dilemma that open molecular POCT platforms may face.

 

 

1. The amplification reagent form is inconsistent.


For molecular POCT, the PCR reaction reagents are generally lyophilized in consideration of room temperature storage and transportation. In contrast, the amplification reagents in traditional molecular diagnostic reagents are still mainly in liquid form.


This means that even if we open the molecular POCT platform to you, you still have to find a way to turn your amplification reagents into lyophilized balls/ powder so that they can be put into our microfluidic chips.


This is more problematic.


Traditional molecular diagnostic reagent manufacturers may not have done the lyophilization of reagents and have no accumulation in this field, so this job may fall on the molecular POCT manufacturers again.


This is not a simple job either.


The lyophilization process itself also needs to adjust the ratio of lyophilized components according to different reaction systems.


In the end, molecular POCT manufacturers need to get your liquid reaction reagents and then do some lyophilization component ratios to figure out.


This way, it becomes a personalized lyophilization process for your home amplification reagent system.

 

 

2. The problem of reagent reaction system optimization.

 

The whole nucleic acid detection is divided into two major parts: nucleic acid extraction and nucleic acid amplification.

 

In the process of molecular POCT product development, in order to adapt to the design of the microfluidic chip itself, also taking into account the room temperature storage and transportation, from nucleic acid extraction reagents to nucleic acid amplification reagents will generally make some corresponding adjustments.

 

In this way, the commercialized reagents from traditional molecular diagnostic reagent manufacturers may not be able to reach the previous performance state when they are directly put in. Therefore, the whole set of reagents should be optimized before being put in. This also requires a certain amount of investment in R&D.

 

 

3. Registration cycle and cost.

 

The molecular diagnostic reagents of traditional manufacturers become brand-new products after being put into the microfluidic chip of the molecular POCT platform. If you want to sell it on the market, you have to re-register it. And molecular diagnostic test kits are three types of certificates. The time and money investment for re-registration is too large.

 

At this time, traditional reagent manufacturers will also be guilty of muttering: I put our reagents into your platform, I have to pay R&D costs to you, and later I have to invest a three-year time, invest a few million to register and get the certificate. So, is your platform reliable or not? Is the cost of mass production of testing consumables as cheap as you claim? Will our cooperation be sustainable in the future? Can you open all the mass production processes of microfluidic consumables to us so that we can produce the whole testing consumables independently? Can you guarantee that you will never do the projects we registered and licensed and that you will never license them to others?

 

This becomes a question of trust.

 

 

4. The issue of trust.

 

Trust is divided into three stages.

 

In the first stage, do traditional reagent manufacturers believe in this molecular POCT platform?

 

I want to invest a lot of time and money in this platform, can you this platform is really stable, and reliable, and whether it really has a competitive market? Often, at this stage, traditional reagent manufacturers will ask for some tests to be performed on this molecular POCT platform. More likely, the traditional reagent manufacturers will want to put their own reagents into this platform for testing.

 

This one gets troublesome again.

 

As mentioned earlier, to put the traditional molecular diagnostic reagents in, you have to make the amplification reagents into lyophilized form, and you may also have to optimize the whole reagent reaction system (from extraction reagents to amplification reagents). This all requires a certain investment.


For molecular POCT platform providers, I think the cost of proving that your reagents can run stably and reliably on our platform is a bit high. It is also unlikely that molecular POCT manufacturers can expect to charge some of the R&D costs of traditional reagent manufacturers until this is proven.

 

In the second stage, the molecular POCT manufacturer has easily proved that the molecular diagnostic reagents from traditional reagent manufacturers can run stably and reliably on their platform, and the next negotiation focus becomes: can the molecular POCT manufacturer completely open the production process of the whole set of testing consumables to traditional molecular diagnostic reagent manufacturers?

 

For traditional reagent manufacturers, this may be the basis of cooperation.

 

Because, on the one hand, the traditional reagent manufacturers are responsible for the future registration of the whole testing consumables and eventually hold the registration certificate of the testing consumables if the core process steps of the whole production of the testing consumables (pro and con water treatment, sealing, etc.) are not carried out in their own factories, this is quite difficult to explain in the quality system (even if there is a registrant holding system).

 

On the other hand, for traditional reagent manufacturers, we have worked hard on your molecular POCT platform to do a good job on the test project, but also got the registration certificate, but can not master the core production process of the test consumables. Then in the future, if our cooperation is a little bit not smooth, you do not play with us?

 

In the third stage, after the molecular POCT manufacturer has opened the production process of the whole set of testing consumables to the traditional reagent manufacturer, can both sides keep the promise in the agreement for a long time?

 

This may mean that, for molecular POCT manufacturers, we have opened this test project to this manufacturer, we are determined not to touch it, and then we will not open our platform to other manufacturers who want to do this project.

 

For traditional molecular diagnostic reagent manufacturers, then we will honestly use this molecular POCT platform to do this project, do not consider doing projects on this platform outside the agreement, even if to do the back in fact I have completely mastered this molecular POCT platform.

 

 

5. The problem with the testing program.

 

The choice of testing items is also a problem.

 

The choice of detection items for molecular POCT is already an open-book test.

 

We all know that those few assays are more promising. That is the molecular POCT platform open process, the traditional reagent manufacturers are likely to want the exclusive authorization of a certain test item. Only in this way, do people dare to continue to invest heavily in this platform. If this is the case, then a molecular POCT platform can not cooperate with several manufacturers.

 

For molecular POCT manufacturers, if good test projects are picked by partners, then what else do they do? If they do not take the path of registration to get a license, based on these partners alone, the money earned to feed themselves?

 

These points are open molecular POCT platform is likely to face the dilemma.

 

Of course, there is a solution, that is, the traditional molecular diagnostic reagent manufacturers to find a molecular POCT platform, and then heavy investment, into their shareholders. It is better to become the majority shareholder of this molecular POCT company. In this way, all those gaming dilemmas brought about by mistrust can be dissipated.

 

Related news

Shenzhen AIVD Biotechnology Co. , LTD.

A4 Building 4th Floor / B5 Building C501, China Merchants Bright Technology Park, Fenghuang Street, Guangming District, Shenzhen, Guangdong Province, China

E-mail: market@aivdbiotech.com  
             info@aivdbiotech.com

Tel: +86-755-26165742   +86 18543132823

WhatsApp:+86 18543132823

facebook facebook facebook facebook facebook

© 2022 Shenzhen AIVD Biotechnology Co.,LTD.      粤ICP备18093805号