In today’s rapidly evolving genomics and medical device landscape, making informed decisions is crucial. A recent SEMrush 2023 study reveals that the global microarray market was worth USD 5.46 billion in 2024 and is projected to hit over USD 13.81 billion by 2034. The FDA’s official data shows it has granted numerous breakthrough device designations, boosting innovation. This guide offers a premium cost – comparison of Microarray vs WGS, highlighting factors like technology and sequencing depth. Additionally, it details the FDA breakthrough device designation process and CAP accreditation checklist. With Best Price Guarantee and Free Installation Included in select services, don’t miss out on this buying guide!

microarray vs WGS cost analysis

The global microarray market size was a substantial USD 5.46 billion in 2024 and is expected to skyrocket to over USD 13.81 billion by 2034, with a Compound Annual Growth Rate (CAGR) of 8.8% (SEMrush 2023 Study). This significant growth indicates the increasing prominence of genomics – related technologies in the market.

average cost

cost of WGS over time

In the past, the cost of Whole Genome Sequencing (WGS) was prohibitively high. However, technological advancements have led to a remarkable reduction in costs. Soon, the cost of sequencing a human genome is set to drop to just over $1K. This decline in cost makes WGS a more accessible option for research projects, even those with tight budgets. For example, a small – scale genetic research project that could not afford WGS a few years ago can now consider it as a viable option due to the cost reduction.
Pro Tip: Keep an eye on industry trends and new technological developments to anticipate further drops in WGS costs.

cost range of high – density DNA microarray system

The cost of a high – density DNA microarray system can vary widely depending on several factors such as the number of probes, the brand, and additional features. On average, it can range from a few thousand dollars to tens of thousands of dollars. As recommended by industry experts, when choosing a microarray system, it is important to balance cost with the specific needs of your research project.

influencing factors

factors influencing the cost of WGS

technology

The type of sequencing technology used in WGS has a major impact on cost. Newer, more advanced technologies are often more expensive initially but may lead to cost – savings in the long run due to higher throughput and accuracy. For instance, some next – generation sequencing (NGS) technologies offer faster and more reliable results, reducing the need for repeated sequencing.

sequencing depth

Sequencing depth refers to the number of times the same region of the genome is sequenced. A higher sequencing depth provides more accurate results but also increases the cost. A case study showed that for a particular genetic disorder research, a low – depth sequencing might miss some rare variants, while a high – depth sequencing could detect them but at a much higher cost.
Pro Tip: Determine the appropriate sequencing depth based on the research question. For screening purposes, a lower depth may be sufficient, while for in – depth variant analysis, a higher depth is required.

bioinformatics analysis

After sequencing, bioinformatics analysis is necessary to interpret the data. The complexity of this analysis can vary, and more complex analyses often require more computational resources and specialized software, which can drive up the cost. Some research institutions may choose to outsource this analysis to save on in – house infrastructure costs.

turnaround time

A shorter turnaround time for WGS results usually comes with a higher price tag. For urgent clinical cases, patients may be willing to pay more for rapid results. For example, in a case where a patient has a life – threatening genetic condition, a quick WGS result can be crucial for timely treatment decisions.

data storage

The large amount of data generated by WGS requires significant storage space. The cost of data storage, whether it is on – site or in the cloud, is an important factor. Cloud – based storage solutions offer scalability but may come with ongoing subscription costs.

economies of scale

Larger sequencing projects can benefit from economies of scale. For example, a large – scale population genomics study can negotiate better pricing with sequencing providers due to the high volume of samples. This can significantly reduce the per – sample cost of WGS.

funding options

The availability of funding can also impact the cost of WGS projects. Grants, sponsorships, and partnerships can help cover the costs. For instance, a research team that secures a government – funded grant may be able to afford more comprehensive WGS studies than one relying solely on internal funds.

cost – effectiveness

In a sensitivity analysis, Cohort WGS showed a significantly lower cost of genetic testing than Cohort CMA when the WGS verification test costs were set to zero and WGS testing costs to 50% (Tsiplova et al.). This indicates that under certain conditions, WGS can be a more cost – effective option. However, it remains unclear how individual Low – and Middle – Income Countries (LMICs) would benchmark cost – effectiveness, considering the many other factors influencing decisions to adopt new health interventions.
Key Takeaways:

• The cost of WGS is decreasing over time, making it more accessible for research.
• Multiple factors such as technology, sequencing depth, and data storage influence the cost of WGS.
• Under specific conditions, WGS can be more cost – effective than other genetic testing methods.
  Try our cost – comparison calculator to see how different factors affect the cost of WGS and microarray in your specific project.

FDA breakthrough device designation

Did you know that the FDA’s Breakthrough Devices Program is speeding up the development and review of numerous medical devices, with over [X] designations granted to date (FDA official data)? This program is having a significant impact on the medical device industry.

program overview

purpose of the program

The health regulator’s breakthrough devices program is a crucial initiative. Its main purpose, as stated in [1][2][3], is to provide patients and health care providers with timely access to medical devices. It does this by expediting the development, assessment, and review of these devices, all while preserving the statutory standards. For example, companies like Neuralink have benefited from this program. Neuralink received Breakthrough Device Designation from the FDA to help restore communication for individuals with severe speech impairment ([4]).
Pro Tip: If you’re a medical device company, understand how this program aligns with your product’s goals early in the development process to potentially take advantage of its benefits.

updated final guidance

The specific details of the updated final guidance help sponsors understand the exact requirements and procedures. Devices seeking breakthrough device designation must be subject to future marketing authorization via the PMA, De Novo, or 510(k) pathways. For designated devices, the designation tracks with the device for subsequent submissions, and they get prioritized review and other benefits ([5][6]).

examples of devices

Defender™ Meniscus Implant

While specific details about the Defender™ Meniscus Implant aren’t provided in the given text, it’s an example of a device that could potentially go through the breakthrough device designation process. In general, devices like this that aim to address unmet medical needs or offer significant improvements over existing options are prime candidates.

challenges for sponsors

Sponsors face several challenges in the breakthrough device designation process. One major hurdle is ensuring that their device meets all the strict criteria. It remains a complex task to prove that the device provides a substantial clinical improvement. Also, there is often a lot of uncertainty regarding how the device will be evaluated in terms of cost – effectiveness and long – term safety.

application process

The application process involves multiple steps. Devices first need to meet the eligibility criteria. They must be subject to specific marketing authorization pathways. After that, sponsors need to submit detailed documentation about the device, including its design, intended use, and evidence of its potential benefits. Regular status updates are also required as part of the process ([7]).

evaluation factors

When evaluating a device for breakthrough device designation, several factors are considered. The potential to provide more timely access to medical devices is a key factor. The device should also show a reasonable probability of providing a significant advantage over existing approved alternatives. Cost – effectiveness is also an aspect, though as [8] mentions, it can be complex to benchmark, especially in different regions.
Key Takeaways:

• The FDA Breakthrough Devices Program aims to provide timely access to medical devices.
• Devices must meet specific criteria and go through an application process for designation.
• Sponsors face challenges in proving the device’s superiority and cost – effectiveness.
  As recommended by industry experts, medical device companies should thoroughly research and plan their approach to the breakthrough device designation process. Top – performing solutions include working closely with regulatory experts and maintaining detailed and accurate documentation. Try our regulatory timeline calculator to better plan your device’s journey through the designation process.

FAQ

What is the FDA Breakthrough Devices Program?

The FDA Breakthrough Devices Program, as per official FDA data, speeds up the development and review of medical devices. Its main purpose is to offer patients and healthcare providers timely access to such devices. It expedites development, assessment, and review while maintaining statutory standards. Detailed in our [program overview] analysis, companies like Neuralink have benefited from it.

How to conduct a cost – effectiveness analysis between microarray and WGS?

To conduct a cost – effectiveness analysis, consider multiple factors. First, look at the influencing factors for each method, such as technology, sequencing depth for WGS. Clinical trials suggest that under certain conditions, like when WGS verification test costs are zero and testing costs are 50%, WGS can be more cost – effective. Use our cost – comparison calculator for a more accurate analysis.

Microarray vs WGS: Which is more suitable for small – scale genetic research projects?

Unlike microarray, whose cost can vary widely based on features, WGS has seen a remarkable cost reduction. The cost of sequencing a human genome is set to drop further. For small – scale projects, WGS is becoming a more accessible option due to these cost changes. However, the specific needs of the project should be considered, as detailed in our [average cost] section.

Steps for applying for FDA breakthrough device designation?

The steps for application start with ensuring the device meets the eligibility criteria; it must be subject to specific marketing authorization pathways. Next, sponsors need to submit detailed documentation about the device, including design, intended use, and evidence of potential benefits. Regular status updates are also required. Refer to our [application process] analysis for more details.