FAQ - Biomeme

How does your system work?

The Biomeme device is a real-time qPCR thermocycler that attaches to an iPhone SE and enables you to perform gold-standard DNA or RNA analysis. Using our truly mobile M1 Sample Prep, you can isolate DNA or RNA from a sample, add it to a target specific Go-Strip and put it into the thermocycler. In less than an hour, you can determine the presence or absence of that target in your sample. It’s like a targeted copy machine for DNA or RNA. If there’s just one copy of your DNA target in your sample, the device turns it into billions of copies, which can then be detected. The iPhone is used to run the hardware and process the results.

What do I do with your device?

Lots of things. Anywhere there is DNA or RNA, our device can be used to detect it. Since there’s DNA and RNA all throughout our world, the sky’s the limit. For now, we’re working with partners in human health, biothreat surveillance, genetic testing, education, research, food safety, environmental monitoring and more. Read more about use cases on our blog. Contact us to discuss partnerships. How can we help you do what you do?

What is PCR?

PCR stands for Polymerase Chain Reaction, a biochemical process used to amplify target DNA sequences. Since its invention in 1983, PCR has become a bedrock technology in molecular biology and biomedical science. DNA consists of two strands of nucleic acid units bound together by pairs of matching bases. When DNA is heated to a certain temperature (usually 94-98°C), the two strands come apart, exposing the bases. Through ensuing cooling and heating cycles, the exposed bases on both strands can then be matched to new bases, creating two new double helices. Done over and over, this process can exponentially grow the number of DNA copies you have. It’s like a targeted copy machine for DNA or RNA. If there’s just one copy of the target DNA or RNA in your sample, the PCR process makes billions of copies, which can then be detected. PCR offers superior accuracy and/or speed when compared to other detection methods, like culture.

How do you use PCR to identify targets in your DNA?

PCR uses primers to copy only the segment of DNA you’re looking for. Primers contain the complements of the first few “letters” of the “word” you’re looking for on your template strand (the first bases of your target sequence). They only bind to the template strand where they find those letters, and thus only those sequences are copied. Real-time PCR works by introducing fluorescent dyes and probes to the PCR process. Devices can then optically measure how much fluorescence there is in your reaction mix and use that to interpret how much target DNA was in your sample.

What's "real-time" PCR?

Real-time PCR is an updated PCR method that allows you to receive results as the reaction proceeds. Instead of waiting for the entire chain reaction to finish, you can watch the reaction proceed in “real time”.

How long does it take?

Our device takes approximately 30 – 55 minutes for a complete run. Contact us for the latest spec sheets.

How is your sample prep lab-free?

Our M1 Sample Prep system eliminates the need for common lab equipment such as pipettes, centrifuges and vortexers. Our proprietary sample prep column fits on the end of a syringe to bind and clean DNA as you pipette up and down from reagent to reagent. See it in action here. It’s important to note that our sample prep system must be validated and adjusted for your sample type. Whole blood, for instance, requires a different sample prep protocol than saliva. Contact us to talk about sample prep possibilities.

Do you have FDA approval?

No, all of our products are currently for Research Use Only and not for use in diagnostic procedures. We intend to take a subset of our products through the US regulatory process in the near future.

How can I obtain your system?

Visit our online store to purchase devices, supplies, or test kits. If you have any questions or would like a custom quote please contact us.

What fluorophores do you recommend?

Currently our device is compatible with FAM/SYBR and Cy5/ATTO647N fluorophores. Isothermal (LAMP) analysis is also possible. Contact us for the latest device spec sheets.

Do you provide master mix? If not, what do you recommend?

We have developed several master mixes: LyoDNA, LyoRNA, and LyoGreen. We also offer Go-Strips with lyophilized master mix. These products are available for sale at our store.

You can also use your favorite commercial or homebrewed master mixes. Note that your master mix should not contain ROX.

What tests do you have?

We have a number of test kits available for sale at our store. You also have the option of developing your own test using our bulk product line. Other organizations are also developing their own tests for use on the Biomeme platform in a variety of industries and applications ranging from biothreat to nutrigenomics to K-12 STEM education. Contact us to discuss potential test development partnerships.

Is your system battery-powered?

Yes. The Biomeme two3 can run for about 6 test runs on a single charge.

How do I charge my device?

The device comes with a power adapter that plugs directly into a wall outlet. Charging takes about 1.5 hours, and the device will still work while charging. Watch this short video here about how to charge your two3 thermocycler.

How many tests can I run on a charge?

On a full charge, the battery can deliver up to six tests.

Do I need to provide my own iPhone to use the two3?

No! Our device comes with the iPhone SE and all necessary software to get started right away.

Will it accept standard PCR tubes?

Yes, the device is compatible with standard 200 µL PCR tubes. However, we highly recommend using Biomeme’s Go-Strips, as they are specially designed for use with our device.

Can the device get through airport security?

Yes. Please make sure the device is turned off, and that the smartphone is turned off or in airplane mode before flying.

How does your system manage data?

The device analyzes test results in real time. The data are stored on the iPhone and synced with Biomeme’s cloud-based data management system when the iPhone has a Wifi or cellular connection.

Biomeme’s web portal and accompanying dashboard enables users to track and manage test results seamlessly from anywhere on any device. Users can also manage and view test results within the iOS application and export raw data as a .csv file via email or text. You can also export results as a .jpg file of the amplification plot with a text description.

Results can be securely sent to third-party databases on a case-by-case basis.

What protections are in place for my results?

We use 128-bit encryption on all data transfer. Human health test data can be stored in a HIPAA-compliant database.

What EHR or EMR systems do you work with?

Our data management system is cloud-based and easily integrated with other cloud-based systems. We work with customers to identify an EHR of choice and then go to that EHR to request an API for that customer’s case.

Do you have an API?

Yes, we have an API that will allow you or your organization to create apps to fit your data management needs.

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