The existing gold-standard method for diagnosing cancers and delineating the boundary between cancerous and healthy tissue during surgery, known as Frozen Section Analysis, is often slow and occasionally inaccurate. Each sample can take 30 minutes or more for preparation and interpretation by a pathologist, which increases the risk of patient infection and adverse impacts of anesthesia. Furthermore, for certain cancer types, frozen section interpretation can be challenging, leading to unreliable results in about 10 to 20% of cases. Now, a powerful tool rapidly and accurately identifies cancerous tissue during surgery, delivering results in roughly 10 seconds - a speed over 150 times faster than existing technology.

The MasSpec Pen from MS Pen Technologies (Houston, TX, USA) is an innovative handheld device that provides surgeons with precise diagnostic details regarding the specific tissue to be excised or preserved. This aids in enhancing treatment outcomes and minimizing the likelihood of cancer recurrence. Each cancer variant produces a distinctive set of metabolites and other biomarkers that serve as identifiers. The MasSpec Pen extracts and analyzes these metabolites to establish a molecular fingerprint of the tissue. Remarkably, this simple and gentle chemical process enables the MasSpec Pen to rapidly deliver diagnostic molecular data without causing any tissue damage.

The disposable handheld device is easy for physicians to operate. The process involves simply placing the pen against the patient's tissue, initiating the automated analysis via a foot pedal, and waiting a few seconds for the result. The pen releases a droplet of water onto the tissue, into which small molecules migrate. The device then propels the water sample into a mass spectrometer, an instrument that detects thousands of molecules to create a molecular fingerprint. A statistical classifier software instantaneously evaluates the molecular fingerprint obtained from an uncharacterized tissue sample by the MasSpec Pen, utilizing a database of molecular fingerprints collated from 253 human tissue samples. These samples comprised both normal and cancerous tissues from the breast, lung, thyroid, and ovary. Upon completion of the MasSpec Pen analysis, the terms "Normal" or "Cancer" automatically appear on a computer screen. For specific cancers, such as lung cancer, a subtype may also be indicated.

In trials involving tissues extracted from 253 human cancer patients, the MasSpec Pen was able to provide a diagnosis in about 10 seconds, with an accuracy exceeding 96%. The technology could also detect cancer in marginal regions between normal and cancer tissues, which exhibited mixed cellular composition. Additionally, the MasSpec Pen demonstrated its ability to accurately diagnose cancer in live mice with tumors during surgery, without causing any noticeable tissue damage or stress to the animals. The MasSpec Pen shows potential for application as a clinical and intra-operative tool for both ex-vivo and in-vivo cancer diagnosis, and was a finalist for the 2023 AACC Disruptive Technology Award. 

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